<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![CDATA[AD/Director Clinical Project Management]]> The AD/Director, Clinical Project manager drives the development and execution of high quality, global, integrated cross-functional clinical and medical affairs project plans in support of the overall program strategy and oversees the initial planning of clinical and medical affairs programs.

Job Responsibilities:
  • Develops and executes high quality, global, integrated cross-functional clinical and medical affairs project plans in support of the overall program strategy
  • Uses project knowledge to plan short-, mid-, long-term project plans and identifying interdependencies
  • Manages the critical path of the project and key project risks
  • Work closely with the Medical Director, Clinical Operations leads and Medical Affairs to ensure clinical study, real-world evidence generation (e.g., patient reported outcomes, registry) deliverables support clinical and medical affairs program goals and project execution
  • Responsible for analysis of Key Performance Indicators
  • Works with Finance, Medical Director Trial Management and Medical Affairs to create initial budget estimates and timelines for planned clinical trials and projects
  • Coordinate risk analysis and contingency planning for clinical programs
  • Leads and participates in the debrief and lessons learned exercises
  • Facilitates Clinical Development governance meetings
  • Uses strong project and organizational knowledge, leadership and active facilitation to enable effective team meetings and high performance teams
  • Develops, maintains, tracks, and manages a high-quality, integrated project plan to enable accurate reporting and decision making
  • Coordinates dashboards
  • Contributes to functional excellence and business improvement initiatives
  • Manages team-level and corporate processes effectively, using strong project and process knowledge, to drive team deliverables


Qualifications/Requirements:
  • Masters or doctoral level (PhD, PharmD, MD, MBA); undergraduate technical/scientific degree Experience
  • Project Management Professional (PMP)® - preferred
  • 10+ years relevant experience in the biotech/pharmaceutical industry
  • 7+ years of relevant project management experience
  • Demonstrated ability to think strategically when planning, managing teams, and managing processes.
  • Skillful use of interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
  • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
  • Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
  • Ability to work effectively with cross-functional teams.
  • Ability to work in a matrixed organization
  • Strong analytical skills with a data driven approach to planning, executing, and problem solving
  • Proficient in creating and maintaining clinical program budgets and timelines
  • Knowledge of GCP and ICH
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Wed, 24 May 2017 00:00:00 EDT 0
<![CDATA[Sr. Study File Specialist]]> Our growing Global Pharmaceutical Client is looking for a motivated and experienced Sr. Study File Specialist. The Study File Specialist will report to a Study File Manager and work alongside other Study File Specialists as the go-to person regarding the support and process of eTMF/TMF for multiple studies. One large Phase 3 study will be starting soon and this person will have a lot of interaction with that study.  

The Study File Specialist will provide support for Trial Master File (TMF) activities to the clinical teams for 5-8 studies.  This role will be responsible for working with study teams, both internal and external, to author TMF Plans, perform document review in eTMF, assist with training and implementation of the eTMF and complete TMF completeness checks for assigned trials.  General activities include, but are not limited to:  review of TMF processes and system for continuous improvement, continued relationship building with key stakeholders and customers, and assist study teams with inspection readiness activities.  The Study File Specialist will evaluate and report on key deliverables in support and as directed by management.

The target background for this role is someone that has worked in study start up and has handled the TMF process. Someone that now only knows the documents but also knows how to set standards and how to check for accuracy and has helped teams put together a TMF plan and follow it through. Teams are global and someone that is interested in being the point person and is confident both on the phone and in person will ensure success of the position. Specialists will be working on studies that are starting and may also have some older studies that they would be reviewing.

Job Responsibilities:
  • Assist with implementing processes for Trial Master File (TMF) activities.  Liaise with study teams to facilitate knowledge and use of TMF tools and processes to standardize procedures. 
  • Assist with  implementation of the framework for a standard, global structure and maintenance of the Trial Master File (TMF)
    • Use recent audit findings and consultant review to understand current status across sites, inconsistencies and gaps
    • Continuous evaluation of electronic document repositories in use
    • Use experience and knowledge of ICH GCP and Code of Federal Regulation Guidelines to design globalized standard structure for TMF
    • Identify and develop templates, tools and processes for TMF set-up and maintenance
    • Act as vendor liaison for standardized document filing across projects
    • Collaborate with CQA and Clinical Quality Compliance team to ensure global submission and inspection readiness of TMFs as appropriate
  • Perform TMF completeness reviews within the indicated timelines to ensure TMFs are inspection ready at all times.  This includes providing guidance into the ongoing TMF QC checks study teams perform. 
  • Assist with reporting TMF related metrics to management; used to show inspection readiness and completeness of TMF. 
  • Develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all geographical regions. Foster communication with management throughout the organization to promote increased cooperation and accountability. 
  • Work closely with study teams fielding, escalating and resolving TMF related issues.
  • Ad hoc support for any activities within Study Operations in support of meeting objectives or timelines.  This may include archiving study files or filing documents into the TMF


Qualifications/Requirements:
  • 4+ years clinical research experience within the pharmaceutical industry
  • Bachelor Degree in a Business related discipline.
  • Moderate experience in the set-up and maintenance of Trial Master File infrastructures and sound knowledge of regulatory requirements for global submissions
  • Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
  • Involvement in cross-functional, multicultural and international teams.
  • Excellent ability to handle complex decisions.
  • Experience in oversight of vendors highly desirable.

Nice To Have’ s:
  • Expereince using Veeva Vault
  • Experience working with standard, TMF Reference Model
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Tue, 23 May 2017 00:00:00 EDT 0
<![CDATA[Sr CRA - East Coast]]> Growing International CRO is building a US monitoring team. Oncology or complex therapeutic area monitoring experience is required.  Monitoring regions are West Coast, East Coast and Texas near major airports.

Job Responsibilities:
  • Administration and full investigator site responsibility for clinical studies
  • May assume line management responsibilities for CRAs and assist PM as needed
  • Ensures clinical trials are monitored such that subjects' rights, safety and well-being are protected and that the clinical trial data are reliable.
  • Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
  • Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
  • Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities
  • Performs pre study visits
  • Performs initiation visits
  • Performs monitoring visits
  • Understands and updates Clinical Trial Management System (CTMS) in a timely manner
  • Monitors and updates data in an Electronic Data Capture (EDC) system
  • Demonstrates a broad understanding of the SAE reporting process to regulatory authorities
  • May write SAE narratives to support pharmacovigilance activities
  • Prepares accurate and timely visit reports from all types of visits
  • Assists in business development


Qualifications/ Requirements:
  • Graduate, postgraduate, 4-year college degree or equivalent, ideally in a scientific or healthcare discipline.
  • Three (3) years or more as Clinical Research Associate (CRA) either in Clinical Research Organization (CRO) or pharmaceutical industry.
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Tue, 23 May 2017 00:00:00 EDT 0
<![CDATA[Sr CRA - West Coast]]> Growing International CRO is building a US monitoring team.  Oncology or complex therapeutic area monitoring experience is required.  Monitoring regions are West Coast, East Coast and Texas near major airports.

Job Responsibilities:
  • Administration and full investigator site responsibility for clinical studies
  • May assume line management responsibilities for CRAs and assist PM as needed
  • Ensures clinical trials are monitored such that subjects' rights, safety and well-being are protected and that the clinical trial data are reliable.
  • Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
  • Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
  • Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities
  • Performs pre study visits
  • Performs initiation visits
  • Performs monitoring visits
  • Understands and updates Clinical Trial Management System (CTMS) in a timely manner
  • Monitors and updates data in an Electronic Data Capture (EDC) system
  • Demonstrates a broad understanding of the SAE reporting process to regulatory authorities
  • May write SAE narratives to support pharmacovigilance activities
  • Prepares accurate and timely visit reports from all types of visits
  • Assists in business development


Qualifications/ Requirements:
  • Graduate, postgraduate, 4-year college degree or equivalent, ideally in a scientific or healthcare discipline.
  • Three (3) years or more as Clinical Research Associate (CRA) either in Clinical Research Organization (CRO) or pharmaceutical industry.
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Tue, 23 May 2017 00:00:00 EDT 0
<![CDATA[Director or Sr. Director, Remote Visit Services]]> The Senior Director, Remote Visit Services is responsible for oversight, planning, execution of remote visit trials under the direction of the Vice President, Global Clinical Operations & Remote Visit Services. The Senior Director, Remote Visit Services is an employee and may fill this role for any given period of time.

Job Responsibilities:

Business Development Responsibilities
  • Establish corporate objectives with the Executive Team
  • Works with the Business Development Department to identifies new opportunities with existing clients and potential new clients. 
  • Works with Business Development to meet corporate and departmental sales goals
  • Develops and completes assigned requests for information (RFI) and requests for proposals (RFP) within corporate identified timelines. 

Managerial Responsibilities
  • Develops and tracks objectives and key performance indicators (KPIs) relating to operational project delivery within the Remote Visit Team
  • Develops, tracks and oversees departmental financial objectives in coordination with the finance department. 
  • Oversees all departmental activities and personnel relating to supplier management for clinical activities and adherence to SOP QA-001, Supplier Evaluation and Monitoring
  • Mentors and provides leadership support to Remote Visit staff
  • Monitors contracts for compliance and implementation to ensure adherence to regulatory standards
  • Complies with the Quality Management System (Quality Manual, SOPs) and maintains all assigned controlled documents
  • Contributes to and participates in the Management Review Meetings by developing and presenting results
  • Trains, mentors and supervises department personnel

Department Responsibilities
  • Allocates departmental resources as appropriate
  • Oversees remote visit clinical tasks and study activities
  • Point of contact for sponsor and supplier issues and escalation to include obtaining customer feedback
  • May serve as a main contact (project manager) on select projects
  • Attend internal start up meetings for new projects
  • As needed, coordinate, attend, and lead client visits and teleconferences
  • Oversee or participate in clinical tasks as needed
  • Identify possible improvements to current processes, determine new processes that are needed and initiate and implement new processes
  • May be used as a clinical resource for a project or to reach a milestone


Qualifications/ Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, education, and / or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
  • Bachelor’ s degree or equivalent is required, typically in nursing or scientific field. Advanced degree is desirable.
  • At least 8 years of direct clinical research experience including experience in managing sponsors and supplier relations. Global experience required. Experience in multiple therapeutic areas or disease state/indications required.
  • Current knowledge of and the ability to apply ICH/GCP and all applicable regulations and guidelines.
  • Responsibility for cross-functional program management required. Client management required.
  • Must have demonstrated a high level of core and technical competencies of a Project Manager or equivalent and demonstrated potential for leadership.
  • Competent in application of standard business procedures (SOPs, Global Regulations, OEC, Outsourcing).
  • Participates in and is key contributor to initiatives and advancement of the organization.
  • Management of employees, mentoring, oversight providing issue escalation and resolution, oversight of project, team management.
  • Well organized and able to multi-task.
  • Positive and energetic attitude.
  • Able to drive a team to work both independently and as a team.
  • Able to give clear and concise directives. Professional, well spoken, articulate.
  • Global travel may be required (30%) to meet with clients as appropriate
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Tue, 23 May 2017 00:00:00 EDT 0
<![CDATA[Contract NDA Submission Project Manager]]> My client is currently seeking a Contract NDA Submission Project Manager to fill a role on site for up to 1 year.

Job  Responsibilities:
  • Provide support to ensure the Regulatory Lead and cross functional program team develop and seamlessly execute global regulatory strategies enabling successful marketing applications with Health Authorities.
  • Utilize robust project management methodologies to ensure the development, utilization and continuous improvement of tools and processes to meet project deliverables.
  • Ensure product specific strategies are documented, maintained, updated and proactively coordinated and endorsed by key stakeholders. Ensure transparent and constant communication of objectives and strategies across program teams, sub-teams, and senior stakeholders.
  • Encourage and model creative problem solving and demonstrate innovative approaches in working within a dynamic environment. Assist regulatory lead in problem solving and generate options to enable effective and timely decision making.
  • Develop and maintain project plan and ensure execution of regulatory filing focused on quality and schedule.
  • Prepare and coordinate meetings including scheduling agendas, minutes, action item and decision logs and timelines. Maintain real-time project documentation to ensure alignment and agreement on tasks, timing and approach.
  • Assist with the identification and elevation of potential major and critical project risks / issues as appropriate.
  • As necessary, coordinate key cross-functional tasks in order to deliver high quality deliverables on schedule.
  • Prepare and distribute reports and trackers to communicate updates and project status.
  • Communicate and drive follow-up on action items as well as provide project status updates to internal & external Partners/Vendors/CMOs/CROs.
  • Track project variances and report and prepare variance reports. Assist with the identification of root causes of variances.


Qualifications/ Requirements:
  • Experience in the submission and approvals of NDAs and MAAs in the role of project manager.
  • Thorough understanding of US & Global regulations, standards and guidance documents.
  • Experience in Project Management leading cross-functional drug development or regulatory teams - PMP Certification or equivalent highly desired.
  • BS degree in Science discipline - Chemistry, Biochemistry or equivalent with at least 3 years in a related position in industry.
  • Experience corresponding and interacting with regulatory agencies, particularly with the FDA.
  • Technical Writing Skills.
  • Ability to effectively organize, multitask, and works in a fast-paced, deadline driven work environment.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Strong team player that has a customer service approach and is solution-oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Possess strong written and verbal communication skills.
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Mon, 22 May 2017 00:00:00 EDT 0
<![CDATA[Director of Nursing]]> Our client in the Northwest Suburbs is looking for a Director of Nursing:

Job Responsibilities:
  • Develop and maintain nursing service objectives, standards of nursing practice, and the implementation of nursing policies and procedures
  • Oversee the recruitment, retention and the orientation practices of nursing and restorative/rehab staff
  • Provide sufficient staff to ensure uninterrupted service to the residents at all times
  • Maintain a procedure to ensure that all licensed personnel have a current and valid license as required by the State, and that the State of Illinois appropriately registers all certified personnel
  • Maintain personnel records for all nursing staff (hiring, counseling, and terminating employees)
  • Evaluation/performance review oversight of all personnel under the direction of the Director of Nursing
  • Develops rapport with residents and families and develops systems to encourage communication between residents/families/staff
  • Develops/implements communication patterns between food service, and nursing departments
  • Develops/implements communication pattern between restorative/rehab department and nursing departments
  • Responsible for the fiscal management of the nursing department
  • Responsible for the oversight of the nursing management team and the development of their teamwork approach in providing the best clinical outcomes for the residents
  • Responsible for nursing department annual mandatory inservices
  • Provide clinical support, as needed, to other facilities within the corporation
  • Oversees the process of evaluation and assessment of employee injuries to determine the need for treatment in an outside facility. Works in conjunction with the facility Human Resources Manager to exchange information and to coordinate a complete filing with the workers’ compensation carrier. Follows up with documentation of work status orders of employees receiving treatment.
  • Acts as a member of the Quality Assurance Committee and utilizes available reports and information to develop and prioritize plans for improvement if necessary
  • Responsible for identifying, investigating trigger events in accordance with state, federal and organization guidelines
  • The DON has a leading role in promoting through role modeling, education and program development the facility’ s Culture Contract components
  • Promotes and partners with all facility staff to provide quality customer services.
  • Assist other team members when necessary
  • All other duties as assigned


Qualifications/ Requirements:
  • Full-time RN who has knowledge and training in nursing administration and restorative/rehabilitative nursing.
  • Knowledge and training of geriatric residents.
  • Graduate of an accredited nursing program with an Illinois RN license.
  • CPR certified
  • Possess excellent communication skills
  • Nursing Home Administrator’ s license is a plus
  • Must be able to read, speak and understand the English language.
  • Must be able to propel a patient / resident in a wheelchair.
  • Must be able to move items at least 15 pounds.
  • Must be able to assist patients /residents in evacuating the building in an emergency
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Mon, 22 May 2017 00:00:00 EDT 0
<![CDATA[Systems Coordinator, Clinical Compliance and Operations]]> Ensures that systems, SharePoint sites, data/document transfer mechanisms and Clinical shared Email-boxes are compliant with applicable laws, regulations, directives, and regulatory guidance.

As a member of the Clinical Compliance function, the Systems Coordinator is a model of regulatory and quality systems compliance and should function as a subject matter expert and advisor to his or her colleagues throughout the organization.

Job Responsibilities:
  • Coordinates, facilitates and/or conducts the review and selection process for new or replacement Clinical systems, including but not limited to, electronic (e) data capture (EDC), e-signature, e Trial Master File (TMF), Clinical Trial Management System (CTMS), secure data and document transfer mechanisms
  • Manages implementation and maintenance of new and replacement Clinical systems
  • Manages access to Clinical systems
  • Manages upgrades to Clinical systems
  • Manages vendors relevant to Clinical systems
  • Manages Clinical SharePoint sites, including access
  • Interfaces with IT and other functions and departments as needed to ensure effective systems support for the Clinical functions
  • Develops and implements appropriate processes relevant to Clinical systems
  • May manage Clinical email-boxes as assigned
  • May also be responsible for managing, directing, or mentoring Clinical staff, and consultants or contractors
  • Other tasks as assigned


Qualifications/ Requirements:
  • BA or BS (or equivalent ex US) degree
  • Thorough knowledge of 21 CFR Part 11 as well as US and global privacy regulations
  • 3+ years’ experience in the medical product industry
  • Strong analytical skills.
  • Proficient in Microsoft Office, Adobe Acrobat, SharePoint, and clinical systems
  • Professional, proactive demeanor
  • Strong interpersonal skills
  • Excellent written and verbal communication skills
  • Ability to sit and stand for extended periods of time
  • Ability to carry, handle and reach for objects
  • Manual dexterity to operate office equipment, e.g. computer, phones, etc.
  • Ability to travel independently up to 25% over the course of a year
  • Action Oriented
  • Problem Solving
  • Organization
  • Functional/Technical Skills
  • Priority Setting
  • Drive for Results
  • Strategic Agility
  • Intelligence Horsepower
  • Dealing with Ambiguity
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Fri, 19 May 2017 00:00:00 EDT 0
<![CDATA[Administrator]]> Our client in the South Suburbs is looking for an Administrator for their Long Term Care Facility.

Job Description:
  • The Administrator is responsible for organizing, staffing, directing, coordinating, reporting, budgeting, inventory control, and management of the facility, people, supplies and equipment in partnership with their direct reports in such a way that meaningful services are established to render the optimum level of resident care.
  • This individual is expected to develop and encourage a teamwork approach within the facility and corporate structure as it pertains to facility issues.
  • Promotion of the facility’ s Culture Contract in all aspects of their role, both for residents, families and staff.
  • Oversee the recruitment, retention, and orientation practices of new employees within the Social Service Division, Activity Division, Dietary and Environmental Service personnel
  • Complete personnel records for all areas of supervision including: Hiring, counseling and terminating employees
  • Evaluation/performance review of all personnel
  • Management of the overall social services and activity programs
  • Oversees the activity budget
  • Management of the facility Information Management systems
  • Supervision of the Dietary department by working in a collaborative manner with the Food Service Supervisor to provide nutritious meals following dietary standards
  • Oversees the Environmental Services department and working in a collaborative manner with the Environmental Services Director to provide a sanitary living environment for the residents
  • The Administrator  is considered the Site Information Systems (IS) Coordinator within the facility. As the Site IS Coordinator, the Administrator  should be familiar with computers and the Windows environment, and willing to learn and share information with other computer users in the facility regarding the utilization of the facility software and network. Responsibilities include:
  • Oversees the facilities network backup
  • Communication between the facility and the corporate MIS department regarding electronic policies and procedures, computerized management reports and other important computer files
  • Communication between the facility and the corporate MIS department regarding software, hardware and network maintenance
  • Communication between the facility and the corporate MIS department regarding all computer related training needs
  • Assist other team members when necessary

Job Qualifications:
  • Active Licensed Nursing Home Administrators License in good standing.
  • Bachelor' s degree from a four-year college or university.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • To perform this job successfully, being able to manipulate through programs on the computer. Knowledge of Excel Spreadsheet software and Microsoft Word software.
  • Must be able to read, speak and understand the English language.
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Thu, 18 May 2017 00:00:00 EDT 0
<![CDATA[Strategic Markets & Corporate Accounts Specialist]]> Under the direction of the VP will be responsible for developing and implementing account specific business plans and achieving sales targets, serving as the primary account contact for key markets. Provide support and assistance for worldwide Corporate Accounts to ensure continued growth and profitability. Contributes to and supports Corporate Accounts strategies. 

Job Responsibilities
  1. Identify new sales opportunities across group practices within specified regions in the U.S. market. 
  2. Generate and manage reports and other contact information.  Develop reporting for quarterly business reviews.  Create and maintain master lists of key contact information for group practices, VA, CHCs, Indian Health and Correctional Facilities. 
  3. Marketing and support.  Coordinate logistics and distribution of information with North American Sales Team, which includes newsletters, quarterly mailings, and PowerPoint presentations. Recommend support materials that focus on continuing education courses, presentation materials, and education support.
  4. Work closely with the marketing communications department in a project management capacity to drive due dates and deadlines based on annual marketing plan.  Develop marketing programs and develop strategies to promote new products as well as entire product line. In cooperation with Marketing Communications, develop sales aids, brochures, ads, pads, laminated sell sheets promotional package production/mailing and marketing pieces to promote products and increase sales. Review dealer websites on a regular basis to ensure company presence is accurate and up-to-date.
  5. Work with sales team to create and maintain a support plan for all customers.
  6. Outbound sales.  Make calls to key accounts to enhance communication relations while maximizing sales opportunities. Answer sales questions that cannot be addressed by Customer Care.  Help ensure that information needed for Customer Care to answer questions is available on systems that meet the requirements of the user.
  7. Work closely with Corporate Account Managers to oversee spiffs, rebates and incentives.  Provide promotional incentive updates on a regular basis including:   performance to goals, ranking, and contest updates. Work with Corporate Account Managers and Product Managers to identify and coordinate promotions based on strategic initiatives/marketing plans to achieve sales growth. 
  8. Attend and support dental and dental hygiene events, dental conventions, dealer sales meetings, open houses, continuing education seminars and professional meetings to promote product lines. Coordinate meeting logistics onsite or offsite, if needed.
  9. Manage invoices and tracking systems, along with coordinating payment of special dealer reward points.
  10. Completes other duties as assigned.


Qualifications/Requirements
  1. Bachelor degree in Business or equivalent work experience
  2. Minimum 2 years experience in marketing, marketing communications or sales
  3. Knowledge of the dental field preferred. 
  4. Exemplified analytical skills
  5. Self-starter with excellent time management  and follow-through skills
  6. Excellent computer and internet skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
  7. Excellent organizational, interpersonal, analytical, written and oral communication skills.
  8. Valid Driver’ s License and accommodation of an overnight travel schedule of up to 25%.
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Thu, 18 May 2017 00:00:00 EDT 0
<![CDATA[Sr. Director/Director Clinical Research - GI]]> My pharmaceutical client is seeking a talented, highly motivated and experienced pharmaceutical physician interested in joining a fast-paced company. The primary responsibility of the Senior Director/ Director of Clinical Research will be to provide medical expertise and leadership necessary to advance one or more of the Company’ s lead drug candidates through Phase I, II, III and Post-approval clinical trials. There are two positions and depending on someone’ s therapeutic area experience each person will be assigned a drug candidate. Key areas – Rheumatology, nephrology, GI.

The Senior Director/ Director, Clinical Research, will drive the design, planning, and implementation of clinical program/s and study protocols for drugs that are in all phases of development, and will play a key role in driving the clinical development strategy and supporting related regulatory activities. This clinical development expert will also support attainment of corporate strategic objectives by contributing their clinical, scientific and development expertise to business development initiatives, co-development partnerships, and development plans for pre-clinical programs. 

The Sr. Director/Director, Clinical Research will report to a Sr. VP of Pharmaceutical Development.

Job  Responsibilities:
  • Lead the creation of clinical strategies and development plans for assigned programs across development phases, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
  • Be the recognized clinical expert for these development program/s both within and external to the client
  • Provide medical input into the design of clinical trials for these development programs
  • Serve as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members, including external partners, to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget
  • Assist in the preparation of clinical protocols and FDA/EMA documents (eg., INDs, annual reports, meeting requests, briefing books, and NDAs) and other relevant clinical documents
  • Provide authoritative clinical leadership in preparation for and interactions with Regulatory Authorities
  • Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I to III safety and efficacy trials; assist in generating the study reports and publications from these trials
  • Establish strong Scientific Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and protocols
  • Collaborate with other members of the Clinical Affairs and broader R&D teams on medical matters related to drug development
  • Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs
  • Provide clinical, scientific and development expertise to business development initiatives
  • Travel 20% to conferences
  • May or may not have direct reports, group is evolving from recent changes and this will be determined at a later time


Qualifications/ Requirements:
  • MD or DO degree with Board Certification in GI, Neurology, Rheumatology (depending on area of specialty)
  • Medical expertise in internal medicine
  • A minimum of six years of pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3 and post-approval; for Director, a minimum of three of relevant industry experience
  • Possesses thorough understanding of strategic and operational aspects of clinical research and product development
  • Strong general knowledge of regulatory requirements such as apply to clinical drug development, with significant experience interacting directly with Health Authorities

Preferred qualifications:
  • Translational medicine expertise a significant plus (not required)
  • Persuasive, effective and flexible in interpersonal interactions at all levels, with strong oral and written communication capabilities
  • Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environment
  • Strong project management and problem-solving skills
  • Specialty training and board certification, or expertise in rheumatology, nephrology, GI would be ideal
  • Displays sense of urgency, and a willingness to be a “ player/coach” able to roll up sleeves to get the work done when necessary
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Wed, 17 May 2017 00:00:00 EDT 0
<![CDATA[Contract Corporate Recruiter]]> Our client is actively looking for a Sr. Recruiter to join the corporate recruiting team for North America division.  The Corporate Recruiter will drive the full-cycle recruitment process for all departments, at all levels of the organization. The ideal candidate will be organized, detail-oriented and a self -starter with a passion for identifying top talent for the organization.  In this highly visible role the Corporate Recruiter will play a critical role in partnering with the hiring managers to source, screen and hire candidates that are best suited to support the growing needs of the business.

Job Requirements:
  • Ability to build strong business relationships with hiring managers and senior leadership to provide the best in class recruitment solutions.
  • Strong negotiation skills and the ability to listen, advise, and influence business leaders.  Good written and oral communication skills. 
  • Ability to develop networks of candidates to support a strong pipeline of qualified candidates. 
  • Passion for searching for information and recognizing new techniques for sourcing potential candidates. Skilled is employing Boolean search techniques and using social media such as LinkedIn.
  • Understands how and when to utilize different recruiting strategies. 
  • Project management skills to be to manage multiple recruitment projects concurrently.  
  • Appreciates and is disciplined in the development and adherence to business processes that ensure consistency and standard hiring operations. 
  • Support and participate in outreach initiatives for diversity and college program. 
  • Previous HR generalist experience is a plus.
  • Demonstrates the core values of company – Customer Focus, Quality, Integrity, Collaboration, Creativity, Passion and Commitment. 


Qualifications:
  • Bachelor’ s degree in Human Resources or related field
  • 5 + years of experience in recruitment, screening, selection and placement
  • In-depth knowledge of recruitment based web sites and sourcing tools.
  • Experience utilizing an ATS, preferred.
  • Experience recruiting in the pharmaceutical, life sciences, or related industry a plus.
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Tue, 16 May 2017 00:00:00 EDT 0
<![CDATA[Payroll Coordinator]]>   A national engineering consulting firm seeks a Payroll Coordinator.  Primary objective is processing of bi-weekly payroll  for over 2, 000  employees.

Job  Responsibilities:
  • Processing of multiple payrolls
  • Verify the processing of new hires and terminations
  • Work closely with field offices regarding payroll issues
  • Update reports, schedules, and spreadsheets in Excel
  • Maintain confidentiality of employee records
  • Recognizes, researches and resolves employee/system issues


Qualifications/ Requirements:
  • 2 – 4 years payroll experience
  • Proficient experience using Excel required
  • Ability to work with confidential information
  • Good organizational and time management skills
  • Able to work under deadline pressure
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Tue, 16 May 2017 00:00:00 EDT 0
<![CDATA[HR and Office Manager]]> The HR Manager  provides guidance, support, and coordination in the consistent and effective application of policies, procedures, and practices of the Human Resources Department. Candidate must have strong foundation in all aspects of HR including Benefits, Compensation, Recruitment, and Employee Relations. The overall responsibility of the  HR Manager  is to assist the executive team in every aspect of human resources by responding to any and all queries of associates. 

Job Responsibilities:
  • Manages all employee relations for respective teams and develops solutions by collecting and analyzing information; recommending courses of action 
  • Oversee the employee onboarding process  including assisting in post recruitment efforts, new hire employee orientation, scheduling and paperwork
  • Manage and maintain all employee information  including files, digital library and records in accordance with EEO, privacy, and related requirements
  • Assist  in Benefits administration, including open enrollment and audits, as well as managing other ancillary benefits
  • Provide a high level of service to employees for all general HR issues
  • Research sources for viable candidates: schools with applicable programs, competitors, area employers, professional associations, etc.
  • Source passive candidates
  • Establish and maintain relationships with recruiting vendors


Qualifications/  Requirements:
  • Bachelor’ s degree
  • Minimum7-10 years of progressive generalist experience in human resources
  • Broad knowledge of general employment laws, recruitment, EEO/AAP, safety training and policy development, benefits and compensation
  • Ability work in fast paced, complex environment with sensitivity to confidential and proprietary information
  • Ability to prioritize, plan and use time effectively.
  • Organization and accuracy skills and able to monitor work for quality.
  • Strong working knowledge of HRIS Systems, ADP Workforce preferred
  • High functional knowledge of Microsoft Excel, Word
  • Strong communication skills, both verbal and written
  • SPHR/or PHR preferred
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Tue, 16 May 2017 00:00:00 EDT 0
<![CDATA[Total Rewards Analyst]]> This position is responsible for applying compensation and benefits knowledge and subject matter expertise. Responsible for maintaining, planning, and coordinating all Total Rewards programs, including compensation, benefits and wellness programs, policies, and procedures.  Responsible for ensuring programs meet employee needs, comply with legal requirements, and are cost effective. Proactively ensures the compensation and benefits programs enhance the organization' s ability to attract and retain employees.

Job Responsibilities:
  • Responsible for implementing and managing all aspects of corporate compensation programs including; Partnering with other members of HR, Finance, and management to ensure jobs are priced according to market and the corporate compensation philosophy, design incentive plans including modeling and forecasting,  develop recommendations for compensation adjustments based on benchmarks and market trends, lead and manage the annual merit and bonus process, and develop and implement improvements to the merit and bonus process.
  • Implement and maintain existing and new benefits and wellness programs and related policies, including all health and welfare programs and the 401(k) retirement plan.
  • Works closely with insurance brokers and consultants on annual renewals and day to day administration of benefit plans.
  • Oversees and administers all activities for employees, including open enrollment, employee changes, and activities related to new hires and terminations.  Coordinates the communications related to employee benefits and compensation activities, including preparing and conducting presentations as requested.  Develops and implements improvements to the open enrollment and benefits administration process.
  • Works with Sr. Director HR and brokers to ensure plans remain in compliance with applicable federal and state and to complete annual 5500 filings, audits, etc. 
  • Partner with Sr. Director HR on global compensation projects.  Investigates and provides recommendations on new compensation programs in different areas of the world where the company operates.  Conducts market-pricing of global positions.
  • Partners with Sr. Director HR on investigation of ancillary health and welfare benefits packages and retirement programs in various countries.
  • Maintains records of cost of benefits and compiles data for cost analysis.  Reconciles and processes all benefits related invoices, as well as ensures the tracking of disability payments.
  • Assists managers and employees with inquiries related to compensation and benefits.
  • Participates in benefits and compensation surveys.  Researches and analyzes published surveys to gather data on positions and determine company' s competitive position.
  • Participation on and coordination of the activities of the company’ s 401(k), Benefits, and Wellness Committees.
  • Responsible for day to day oversight of workers’ compensation program including communication with broker, insurer, and claimants, claims review and management, return to work programs, OSHA reporting, and participation on the company Safety Committee.
  • Responsible for leave of absence administration including vacation and sick/personal day policies, FMLA, STD, LTD, military leave, etc.
  • Partner with the HRIS & Compliance Specialist, as appropriate, regarding Benefits needs related to the HRIS system.  
  • Complete other responsibilities, as assigned.


Qualifications/Requirements:
  • 3 - 5 years of professional compensation experience
  • Bachelor’ s degree in human resources, business administration or accounting or equivalent work experience.  CCP/CBP/CEBS/PHR a plus.
  • Experience in administering benefits programs and current knowledge of applicable federal, state and local labor laws preferred.
  • Experience in a manufacturing environment a plus.
  • Intermediate to advanced Microsoft Office skills (Word, Excel, PowerPoint)
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Tue, 16 May 2017 00:00:00 EDT 0
<![CDATA[HR Business Partner]]> This position is a multi-faced position requiring the individual to be a(n): strategic business partner, operations manager, and proactive, employee mediator within his or her assigned business area in support of that area’ s leadership and business strategy.

This position is responsible for developing the next generation of business leaders in conjunction with the business area’ s leadership and management.   The  HRBP  must understand the business processes and unique skills required of his or her assigned business areas in order to support management and its employees in effectively and efficiently transacting business, as well as supporting talent acquisition in the identification and selection of additional talent resulting from business growth. 

The HRBP  is also a key partner with business leadership in the communication of the corporate culture and continual assessment of employee engagement providing recommendations to business leaders recommending different forums to improve continued communication and facilitation of employee-management discussions, reward and recognitions, and problem-solving.   Managing conflict and providing mediation between employees associated with personality conflicts, work-related misunderstandings, and evolving organizational needs is also a key role of the  HRBP.

Job Responsibilities:
  • Partners closely with management and employees to assure proper documentation, communication and alignment of management expectations is clearly stated in relation to the employees’ work product which supports our corporate goals and objectives.
  • Supports management and employees in improving work relationships by ensuring two-way communication between employee and direct supervisor occurs frequently relative to performance results for both project and transactional-based work assignments.
  • Partners closely with management and employees to create a safe work environment where all employees’ feel comfortable to do their best work and maintain a superior level of engagement, thereby improving work relationships, building morale, and increasing productivity and retention.
  • Provides guidance and input on business unit restructures, workforce planning and succession planning.
  • Proactively identifies training and developmental needs and collaborates with management to ensure employees have a developmental plan and the opportunity to work the plan.
  • Conducts regular (e.g. weekly) meetings with respective business units and functional leaders, and actively participates in departmental meetings.
  • Manages and resolves employee relations issues, in conjunction with senior HR leadership when necessary. Conducts effective, thorough and objective investigations.
  • Working knowledge of legal requirements related to day-to-day management of employees, reducing legal risks and ensuring regulatory compliance. Partners with the legal department as needed/required.
  • Partners with management and, as applicable, Talent Acquisition, for new hires, promotions and transfers related to job descriptions, onboarding plans, development plans and other items/actions to ensure a positive transition. *


Qualifications/Requirements:
  • Minimum of 8-10 years' experience resolving complex employee relations issues.
  • A bachelor’ s degree or relevant human resources experience.
  • Advanced degree and/or Human Resources Certification preferred (e.g. PHR, SHRM-CP).
  • Working knowledge of multiple human resource disciplines, to include several of the following: compensation practices, organizational diagnosis, employee relations, diversity, performance management, talent management, recruiting, federal and state respective employment laws.
  • Professional image and comfortable working in a global matrix organization with the ability to quickly form effective working relationships at all levels.
  • Excellent interpersonal, organizational and effective leadership skills.
  • Professional handling of confidential matters.
  • Proven project management skills with cross-functional teams with the ability to lead and manage small to mid-scale projects.
  • Ability to prioritize and oversee multiple projects in a fast-paced environment
  • Demonstrates superior judgment and excels at utilizing information to build business case and enact positive change.
  • Communicates a " can do" attitude and positive outlook.
  • Excellent written and verbal communication (listening) skills.
  • Intermediate MS Office Skills: Word, PowerPoint, Excel
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Tue, 16 May 2017 00:00:00 EDT 0
<![CDATA[Director of Benefits]]> You will play an integral role in our relationships with our prospective and present Employee Benefit Clients, your Team Members as well as with our insurance carriers and industry partners. You will use your communication and organizational abilities to help shape how our Employee Benefit Clients are serviced.

Job Responsibilities:
  • The Director of Employee Benefits is responsible for supervising staff and overseeing the workflow of the department. This is inclusive of but not limited to assigning Prospects and Clients to an AM, ongoing training of new product options, approving time off request, conduct performance reviews and meeting with potential department partners such as insurance carriers, wellness vendors and financial institutions.
  • Responsible for workflow of department; assignment of Clients and Prospects for services, renewal and marketing.
  • Sharing pertinent company announcements with team
  • Supervise EB Account Managers and Account Assistant
  • Create and run reports for management on EB block of business by revenue, new case sell, lost business, etc.
  • Develop departmental communications regarding industry updates and Client initiatives based on programs and/or products
  • Responsible for researching and implementing technological programs in compliance with departmental goals
  • Maintain AMS data for employer groups, Prospects and carriers
  • Validate department commissions on a monthly basis including revenue splits with our partner agencies
  • Collaborate with EB and P&C producers on prospective Clients
  • Development of new business opportunities including cross selling for Clients and Prospects
  • Employer assistance with plan elections and contribution strategies
  • Claims assistance
  • Conduct annual performance reviews for EB staff
  • Mentor, train and develop Account Managers and Account
  • Conduct and construct agenda for weekly EB division meetings
  • Proactively reaching out to Clients to understand benefit/employee needs
  • Employee Education meetings – annually or as requested
  • Manage / trouble shoot / research solutions for software systems
  • Regular travel within greater Chicago-area and limited out-of-state travel
  • Work is performed during regular business hours; however, extended hours may be required to complete assignments.

 

Qualifications/ Requirements:
  • College Degree or   equivalent work experience
  • Producer’ s License in  Life & Health
  • Valid Driver’ s License/Owns Car
  • 5+ years in an employee benefits arena with an emphasis on group health benefits in the fully insured and self-insured markets.
  • Working knowledge of ancillary product lines inclusive of dental, life and AD&D, vision, Worksite benefits and wellness programs.
  • Ability to demonstrate leadership, communication, analytical, problem solving and interpersonal skills
  • Ability to direct others and also help train less senior staff
  • Excellent negotiating skills
  • Excellent written and verbal communication skills
  • Solid understanding of brokerage process
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Tue, 16 May 2017 00:00:00 EDT 0
<![CDATA[Clinical Project Data Manager]]> Conduct clinical data management in clinical trials and projects in accordance with SOPs and current regulatory requirements

Job Responsibilities:
  • Responsible for all clinical data management activities in clinical trials and projects in accordance with SOPs and current regulatory requirements
  • Responsible for project management to ensure that all data management goals are met within clinical and project teams
  • Develop and maintain project level standards for data collection and data handling
  • Participate in selection of data management vendors and ensure quality and performance of vendors
  • Lead/participate in development and implementation of advanced/innovative clinical trial processes
  • Contribute to development of data management team by coaching, mentoring, and supporting colleagues  
  • Lead/participate in projects within data management function
  • Stay updated on data management technologies, tools, and solutions and share obtained knowledge within organization


Qualifications/ Requirements:
  • Master’ s or Bachelor’ s degree in life science, computer science, or related discipline
  • At least 5 years (or 7 years with Bachelor’ s degree) experience of data management in pharmaceutical, biotech, or CRO setting
  • Experiences with SAS programming and CDISC data standards
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Wed, 10 May 2017 00:00:00 EDT 0
<![CDATA[Global Labeling Lead, Manager]]> The Global Labeling Lead (GLL) is responsible for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. 

The GLL will reinforce labeling strategy by guiding and advising the Labeling Team on internal labeling guidance and policies and will raise awareness of important factors to consider when revising the label. The GLL will keep up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles. The GLL will also be knowledgeable on key labeling requirements worldwide. The GLL will ensure that downstream impact on CLDs is considered during Labeling Team discussions.  The GLL will advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text. 

The GLL provides project management to the Labeling Team throughout the entire process, from the request to update a CDS/USPI/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets and prioritization plans, ensuring that Labeling Teams are aware of the required timelines and following up with Labeling Team members throughout the process so that deliverables remain on target to meet internal and external deadlines. 

The GLL serves as the GLM primary point of contact for Labeling Teams (e.g. Regulatory Strategist, Safety Risk Lead, Functional Line SMEs, Labeling Justification Document/Clinical Overview author) and will provide day-to-day direction to Labeling Operations Specialists so that labeling can be prepared and managed appropriately throughout processes and systems.  The GLL also interfaces with Hub Labeling Managers and PCO colleagues to support timely and quality submissions globally. 

The GLL will support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.

Job Responsibilities:
  • Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. Manage moderately complex projects with oversight as needed 
  • Engage in and contribute to Labeling discussions around content and format of the above mentioned documents, as well as downstream impact on CLDs worldwide 
  • Act as a reviewer and approver during review of labeling ensuring that content complies with regulatory requirements, guidelines, company policies and procedures and that the label content can be incorporated into CLDs worldwide. 
  • Contribute to prioritization of activities and set clear targets using effective project management. Follow up with Labeling Team to secure their contributions so that internal and external deadlines are met. Identify and assist teams to overcome barriers in achieving quality and compliance. 
  • Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal systems use. 
  • Contribute to the development of continuous improvement of business practices associated with processes and tools. Advocate for new labeling initiatives to immediate labeling stakeholders 
  • For deliverables in scope, support responses to inquiries from colleagues related to inspection activities and regulatory agency questions.


Qualifications/ Requirements:
  • Life sciences, pharmacy graduate or equivalent. 
  • Advanced academic qualifications/degree such as PhD an advantage but not essential. 
  • At least 5 years of pharmaceutical labeling experience preferred. 
  • ‘ Hands on’ pharmaceutical labeling experience associated with content development and maintenance within Regulatory Affairs (Human Medicinal Products);  Perspective from HQ,  Country office and/or Regional Regulatory Strategy (at a global/multi-national pharmaceutical environment) necessary. Experience at the country level is a plus. 
  • Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS); experience in reviewing and understanding of implications of the CDS. 
  • Possesses solid knowledge of external labeling guidelines and regulations and internal labeling policies and procedures. 
  • Understands regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts. 
  • Demonstrated ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages. 
  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and within global environment. 
  • Knowledge of global/regional regulatory guidelines and requirements important. 
  • Excellent written and verbal communication skills essential. 
  • Complete fluency in English Language. 
  • Proven strength in logical, analytical and writing ability essential. 
  • Demonstrated project management skills and attention to detail required. 
  • Proven ability to negotiate, influence and problem solve.
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Tue, 09 May 2017 00:00:00 EDT 0
<![CDATA[Clinical Trial Manager]]> The Clinical Trial Manager (CTM) will work collaboratively with the Lead Clinical Trial Manager to drive ongoing clinical studies.  The CTM will also independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol.  Future growth opportunities would include independently managing   small studies of basic to moderate complexity or defined activities in more complex, multicenter studies (e.g., managing vendors).

Job  Responsibilities:
  • Directly oversees selected vendor(s) to ensure compliance with the contract specifications and applicable SOPs
  • Ensures accurate, timely, and complete tracking of laboratory samples
  • Applies thorough knowledge of GCP/regulatory requirements to all aspects of the study
  • Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’ s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans)
  • Works with the Lead CTM to develop and maintain study timelines
  • Oversees clinical site monitoring activities and co-monitors as needed
  • Conducts training regarding the operational aspects of the clinical trial including protocol, lab manuals, etc. to both internal team members and clinical site staff
  • Provide period quality control of the Trial Master File
  • May represent Clinical Operations in cross-functional initiatives


Qualifications/Requirements:
  • B.S. (or equivalent experience) and 3 – 6 years of relevant work experience OR M.S. (or equivalent experience) and 2 – 4 years of relevant work experience
  • Strong vendor management experience
  • Displays project management skills to projects and/or activities with assistance from Senior Clinical Operations staff
  • Demonstrates ability to communicate and coordinate activities with the internal team, clinical sites and vendors
  • Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
  • Effectively organizes cross functional team (primarily internal)
  • Oncology experience is a nice to have
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Mon, 08 May 2017 00:00:00 EDT 0
<![CDATA[Director of Sales and Marketing]]> Responsible for fulfilling leasing and move in goals. Maintains a positive image of the community with referral sources, residents, and staff personnel. Supervises the sales and marketing personnel at the community.

Job Responsibilities:
  • Schedule, organize and conduct tours with prospective resident of independent and assisted living, memory care and skilled nursing.
  • Responds and follow-up with to all walk-ins, phone ins, mail-ins timely and appropriately.
  • Create, plan and implement with Sales and Marketing Team and Program Director events to bring in prospective residents such as but not limited to: seminars, speakers, themed events, and family nights.
  • Develop and maintain a good working relationship with residents, families and professional providers of care.  
  • Maintains a working knowledge of all software programs.
  • Participates in weekend call coverage in Manager Rotation. 
  • Manage move ins and move outs to achieve maximum revenue.
  • Treat each inquiry with value.
  • Works closely with the Executive Director and Corporate Director of Sales in development and implementation of the quarterly marketing plan.
  • Create and implement a strong community outreach program.
  • Media and Marketing Planning Implementation
  • Meet all expectations of occupancy and budget.
  • In consultation with Executive Director, hires, trains, disciplines and terminates departmental employees in accordance with Corporation policy.
  • Keeps Executive Director informed of all sales activity daily.
  • Maintains Hot Board/Move In Move out board.
  • Communicates any special needs of the incoming resident to the appropriate personnel.
  • Manage use of sales toolbox
  • Assure that staff investigates every alternative before closing a lead.
  • Keeps informed of all trends, developments, concepts and techniques in his/her field that affect product.
  • Understand the need of the senior and the aging process Maintain and work an active, meaningful waitlist.
  • Plan and implement special events monthly which prospects attend.
  • Update competitive analysis quarterly.
  • Maintain confidentiality of all pertinent information.
  • Complies with all Policies, cities, state, and federal regulations pertaining to Residents’ accounts as it relates to Medicare, third party billing, etc.
  • Possesses strong organizational skills and ability to multi-task and meet deadlines
  • Interacts professionally and effectively with all levels of the organization, residents, family members, etc.
  • Performs other duties as assigned.


Qualifications/ Requirements:
  • Bachelor degree from a four-year college or university. 
  • Or one to two years’ experience and or training, or equivalent of education and experience.  
  • Previous sales/admission experience in senior living.  Strong communication skills.
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Mon, 08 May 2017 00:00:00 EDT 0
<![CDATA[Sr. Clinical Study Manager]]> My client is seeking a candidate for a Clinical Operations leadership role, the Clinical Study Manager is responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials.  In addition to exceptional project delivery, they seek strong analytical skill and leadership qualities that will influence our internal team and motivate our CRO partners.

Job  Responsibilities:
  • Broad view of the departmental goals and sees the “ big picture” scientifically and strategically;
  • Regularly interacts with Clinical Affairs and company leadership on matters concerning clinical development status;
  • Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets / timelines and external vendor(s) management.
  • Efficient at clinical trial timeline and budget forecasting, using objective measures and tools to plan and communicate key clinical trial metrics;
  • Exceptional planning, communication, and creative problem solving skills, ensuring trial delivery for one or more clinical trials.
  • Leads by example and mentors other Clinical Operations team members, including employee development through company goal setting, performance management processes.
  • Ensures compliance of clinical trials with federal and applicable regulatory agency requirements.
  • Assists with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations.


Qualifications/ Requirements:
  • BS/MS in science or a health-related field.
  • 4 - 6 years related work experience, at least 2 years in a study management role.
  • Biopharmaceutical (Sponsor) organization experience is a must. CRO experience is also desirable.
  • Demonstrated effectiveness in resolving study management issues;
  • Experience managing and training regional or consulting CRAs within project teams is required; direct line management is not required;
  • In-depth knowledge of the CRO selection and contracting processes;
  • Superb communication skills; effective in objective data interpretation and communication as well as expression of abstract ideas to all levels of the organization;
  • Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
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Fri, 05 May 2017 00:00:00 EDT 0
<![CDATA[Remote Visit Associate]]> The Remote Visit Associate is responsible for management of in-home study visits for clinical trials with high-volume assessments and/or patients with compromised mobility due to chronic/degenerative/terminal illness.

Job Responsibilities:
  • Create, review, and maintain/track essential study start-up documents (eg, study-specific forms, physician standing orders, training procedures, PowerPoint training presentations).
  • Identify, contract, train, and manage in-home nursing agencies and their providers.
  • Conduct inventory sourcing, tracking/coordination, and shipping management.
  • Establish and maintain Sponsor/CRO, Central Lab, and Agency communication.
  • Organize and lead Sponsor/CRO, Central Lab, and Agency teleconferences.
  • Develop and implement internal process improvement initiatives.


Qualifications/ Requirements:
  • Bachelor’ s degree preferably in a science/nursing field or Associates degree/RN with relevant experience.
  • 2-4 years of healthcare-related or CRA experience.
  • Must have demonstrated a functional level of core and technical competencies of a Clinical Trial Assistant, CRA, and/or in other related clinical research positions.
  • Current knowledge of and the ability to apply ICH/GCP and all applicable regulations and guidelines.
  • Clinical research experience and participation in clinical study activities.
  • Competent in application of standard business procedures (SOPs, Global Regulations, OEC, Outsourcing).
  • Mentoring and training of colleagues at a more junior level as well as new hires at the same level.
  • Well organized and able to multi-task.
  • Positive and energetic attitude.
  • Able to take initiative while following directives.
  • Professional, well spoken, articulate.
  • Experience with Service Provider identification and training (as appropriate).
  • Support of Country Coordinator training (as appropriate).
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Fri, 05 May 2017 00:00:00 EDT 0
<![CDATA[VP, Quality and Regulatory Compliance]]> With an in-depth knowledge of the Quality System Regulations and FDA requirements, provides leadership for the Quality and Regulatory Compliance function and the company. Develops the quality, regulatory and compliance strategy, integrating with other types of risks ensuring a seamless risk assessment philosophy for Quality & Regulatory Compliance. Leadership role that require sounds judgement and the ability to assess the likelihood and impact of Regulatory / Statutory risks for the company. Establishes relationships with key external vendors and Quality leaders and serves as the Subject Matter expert for the company in the area of Quality & Regulatory Compliance and Validation.

Job Responsibilities:

Directs the Quality & Regulatory Compliance functions as the Compliance Officer / Quality Management Representative. Demonstrates strategic thinking, manage relationships in the business, resolve and coordinate complex issues across the business, manage vendor relationships, exhibit strong process skills, accountable for the successful implementation of large-scale projects, and strong focus on the customer.

Managerial responsibilities:
  • Responsible for the strategic development of the department.
  • Define departmental platform policies and guidelines.
  • Ensure development of departmental team.
  • Oversee departmental staff and holds responsibility for performance management, for recruitment/retention of personnel, and for expenses approval and budgeting.
  • Supervise staff and consultants as needed. Direct resource planning, budgeting, and restructuring to meet project and organizational/corporate needs.
  • Serve on pertinent internal committees.
  • Provide and atmosphere which is conducive to teamwork.
  • Identify need for, creates, and reviews department Standard Operating Procedures (SOPs).
  • Collaborate with Operations and Business Development personnel to finalize project budgets and scope of work; assists with RFP / RFI completion.

Department Responsibilities:
  • Develop and implement the Quality Compliance Strategy with both senior leadership and business functions within the company. Translates the strategy and vision into goals, objectives and measures for the organization.
  • Assures adherence of Quality & Regulatory Compliance function to requirements of the company Quality System Manual. Maintain procedures and policies; ensuring that Quality & Regulatory Compliance maintains compliance with changes to the company Quality System Manual.
  • Partner with the President / CSO and the company leadership to conduct Quality Management Reviews and institute enterprise management controls to assess and manage risk.
  • Create a culture of enterprise risk management, education and skill development to operationalize effective risk management processes and practices.
  • Provide overall direction and leadership for the Quality & Regulatory Compliance function with robust talent and organization development plans. Provide the coaching, mentoring and leadership to transform the staff from subject matter experts to a cohesive, integrated team of consulting experts.
  • Provide strong leadership in establishing, maintaining, and meeting budgetary requirements.
  • Develop and manage the relationships with key company internal and external Quality leaders. Serve as the Quality and Regulatory Champion in the organization, building awareness and understanding of quality and compliance requirements. Drive a positive cultural change and clear employee accountability for quality and compliance.
  • Remain current with regulatory changes, best practices and new trends in the industry and their impact upon the company bringing appropriate through leadership to Quality & Regulatory Compliance in alternative methods to meet the regulations.
  • Form and lead sub-teams comprised of individuals from the company’ s various functions and strategic vendors to address a specific business goal, risk, or solution.


Qualifications/ Requirements:
  • Bachelor’ s degree in Engineering or Science discipline (for example, chemistry, biology) or a related filed preferred or relevant systems experience. A Master’ s degree in business is highly desirable. Must have 15+ years of relevant experience including interfacing with outside regulatory agencies. Experience must include leadership and a mix of significant quality knowledge and regulatory compliance responsibility. Past experience in Healthcare sector is expected.
  • Ability to develop a deep understanding of the company’ s business strategy, quality, and compliance requirements and existing quality systems environment.
  • Track record of execution on large scale programs that meet quality, time, and budget requirements.
  • Proven experience in managing staff who administer quality systems, including document control, training, supplier qualification, internal audit, nonconformance, CAPA, reporting metrics, leading Management Reviews, and validation services.
  • Understanding of Quality Management System standards and best practices such as 21 CRF (GCP, GLP, GMP), ICH, ISO, Six Sigma, Kaizen, ANSI.
  • Proven track record of sound judgment including abstract thinking and a good balance between an academic and pragmatic approach.
  • Excellent communication skills with being able to formulate vision and translate vision into execution with measurable results.
  • Strong people skills, ability to work with stakeholders inside and outside of the company, able to mentor team members, build and lead teams with diverse backgrounds.
  • Must be convincing champion for change to build quality and compliance culture across the organization.
  • Effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents.
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Fri, 05 May 2017 00:00:00 EDT 0
<![CDATA[Director, Human Resources]]> This opportunity is with an industry-leading Clinical Research Organization.  Using our unique functional outsourcing model, we provide our biopharmaceutical industry clients support moving their new product from initiation to post-approval.

Our extensive global network of resources is composed of highly qualified functional area and operational experts who can assist with complex scientific, operational, and medical project requirements. We combine that expertise to offer a single, reliable bridge from nonclinical work through late-stage trials. Our team delivers comprehensive project solutions that reinforce and enhance the product-development needs of our clients. With our ISO 9001: 2008-certified processes, our goal is to address key objectives and move the compound successfully forward from clinical development to commercialization.

Our agile business model and processes successfully build and deliver solutions that meet needs at competitive prices. We are small enough to be flexible and deliver personalized attention but large enough to access resources that will deliver high-quality results. Our clients hire and rehire us because of our experience and first-rate deliverables. We have worked on the sponsor side, which allows us to anticipate and understand clinical-development needs. When clients partner with us, they gain the expertise and experience of a hands-on senior team that is accountable, accessible, reliable, and dedicated.

LOCAL FLAIR WITH A GLOBAL REACH:
Our core team members have broad experience that allows for a diversified knowledge of global regulations and the ability to provide an outsourcing solution customized to our clients’ needs. Our expertise and long-term working relationships allow for strategic flexibility and consistency across our projects.

Job Responsibilities:
  • Drive execution, alignment and delivery of all HR services in assigned client groups. Manage and track quality of service delivery, including regular client feedback
  • Support the business with organizational change and development, influencing leaders to address complex organizational design issues where required for business success
  • Develop high-performing partnerships with the broader HR team, Talent Acquisition, Talent Management, Finance and other critical partners across the firm
  • Partner with the business on all key talent decisions, providing HR advice, consulting and expertise. Leverage subject matter experts from across the HR function as needed
  • Manage Employee Relations working with legal counsel, HR leadership and other key stakeholders on the identification, escalation, risk mitigation and resolution of employee relations issues
  • Proactively partner with managers and HR team to give advice and counsel to business leaders including interpretation regarding employee practices, policies and procedures
  • Act as the primary interface with the HR Decision Support team for issues and inquiries which relate to assigned groups
  • Partner with Finance and Compensation and Benefits teams on the execution of the annual compensation cycle as well as identified compensation, personal wellness and financial wellness issues in assigned groups
  • Understand and implement compensation philosophy and processes, ensuring tight alignment of specific compensation decisions
  • Partner with the Talent Management team to assess, define and execute the development needs of assigned businesses
  • Help design and manage the annual Talent Agenda, aligned with the firm wide Talent Agenda, priorities and objectives. Leverage and track critical metrics to assess performance against objectives
  • Support clients in the execution of annual talent practices, including performance management, talent review, succession planning, promotions and development
  • Facilitate talent review and succession planning discussions and drive ongoing follow-up and updating of succession plans
  • Provide expert counsel and coaching to support business leaders in their roles and with their own development
  • Work with the Talent Acquisition team to ensure delivery of effective hiring and resourcing plans, and attract the most talented, skilled and diverse workforce by cost effectively leveraging our strong employer brand
  • Facilitate and supervise the campus recruiting program


Qualifications/Requirements:
Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
  • 10+ years' progressive experience within HR BP/Generalist role along with prior leadership experience; background in Consulting industry a plus
  • Demonstrated expertise and experience in a consultative capacity to senior business leaders shaping organizational strategy, goals and alignment
  • Experience working across the various HR disciplines including compensation, recruiting and talent management
  • The ability to execute firm-wide talent initiatives with excellence in a fast-paced, global corporate environment
  • A proven ability to build and sustain high performing partnerships, both locally and globally
  • Familiarity with HR reporting; experience analyzing and presenting findings to the business as well as tracking and disseminating key HR data
  • A Bachelor' s Degree; certifications and course work in specific areas of HR expertise preferred
  • Strong client relationship management and consulting capabilities
  • Analytical skills and ability to come up with creative solutions to changing demands: anticipating the local, regional, global impact
  • Proficiency with MS Office applications and HR systems including PeopleSoft
  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic
]]>
Fri, 05 May 2017 00:00:00 EDT 0
<![CDATA[Sr. Clinical Research Specialist]]> We currently have an opportunity for a Sr. Clinical Research Specialist for our client responsible for project management, implementation and completion of in-house Donor Room and external activities related to all aspects of medical device clinical trials. The candidate will be working independently and will need to be strong in research. They will be responsible for protocol development, CRF design and working with data management to get the proper database aligned with the study as well.

Job Responsibilities:
  • Conduct clinical research throughout all stages of in-house Donor Room and external trials, including design, implementation, monitoring and closeout. 
  • Site initiation including review of trial requirements, GCP, GDP, AE/SAE with site staff and investigator and assists in identifying and performing initial qualifications visits of potential sites.
  • Manage start-up activities, continual monitoring at sites, tracking subject recruitment and enrollment, site issues and reporting of specific trial issues to ensure compliance with regulations and study protocol and mediate all issues with site personnel.
  • Generate monitoring reports: site initiation, monitoring and close out reports as well as final reports per SOPs.
  • Conducts laboratory assessments as required.
  • Serve as the primary contact with in-house investigators and staff for assigned trials. 
  • Develop clinical trial protocols, informed consents, investigator brochure as applicable and training materials.
  • Prepare Excel spreadsheets as database for collection and storage of study trial data and ensure spreadsheets are verified and incorporate appropriate edits for internal trials.
  • Assist site with data collection tools.
  • Obtain required clinical inventory approvals per SOP. Ensure all investigational materials (drug and device) are available, distributed, documented and reconciled accurately.
  • Negotiate budgets and contracts related to each project including clinical sites and contract laboratories).
  • Reporting status of clinical trials and research projects to management.
  • Ensure compliance with the trial protocol and regulations.
  • Work with Statistics to review statistical analysis plans and draft algorithms required for assigned projects.
  • Work with data management to design, review, edit, electronic CRFs for the electronic data capture (EDC) system and draft tables/listings/figures. Ensure all required data for final report are collected.
  • Review of Advertising and Promotion materials for assigned products.


Qualifications/ Requirements:
  • Bachelor’ s degree required; Advanced scientific degree preferred
  • 3-4 years of clinical monitoring experience in a pharmaceutical, biotech or medical device industry preferred (Blood experience a plus)
  • Proven scientific and technical writing; clinical protocols and study summaries
  • Knowledge and understanding of:
  • FDA 21CFR, ICH Guidelines, HIPPA, other applicable local regulations.
  • Good Documentation Practices, Good Clinical Practice.
  • Excellent verbal and written communication, interpersonal and organizational skills; proven track record of management of long-term professional relationships (e.g. clinical sites)
  • Meticulous attention to detail.
  • Proficient with Microsoft Office (Word, Excel, PowerPoint, Adobe Acrobat Professional)
  • Prior experience with industry standard paper and electronic clinical data management systems.
  • Proven team player
  • Ability to travel 30-40% of time
]]>
Thu, 04 May 2017 00:00:00 EDT 0
<![CDATA[Executive Director]]> Supervises the overall day to day operation of the property to ensure the highest quality operation in accordance with Company standard and resident satisfaction. This position is responsible to supervise all property staff and reports to Regional Director of Operations.

Job Responsibilities:
  • On site executive for all operations, acting as contact for all staff, residents, prospects, community organizations, government agencies and the public.
  • Manages budget and cash flow, maintains budget accountability, aggressively anticipates and minimizes negative budget variances and deficits.
  • Hires, trains, disciplines and terminates managerial employees in accordance with human resources policy
  • Maintains all local, state, and federal licenses.
  • Maintains superior training for staff, ensuring that training programs are effectively executed.
  • Creates an environment for pride and quality among all staff, encouraging them to their highest potential.
  • Ensures that buildings, grounds, and property are maintained at the highest standard of excellence through preventative maintenance systems and programs.
  • Maintains resident retention by working with residents and their families, dealing with any issues that arise.
  • Leads staff meetings.
  • Keeps up-to-date with information about competitors.
  • Become an intricate part of the community in social and civic affairs by representing the property in local, state and professional organizations. 
  • Participates on the Manager On Duty program
  • Attends all required training, in-service, and staff meetings.
  • Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
  • Maintains a positive and professional demeanor toward residents, visitors, families, and co-workers.
  • Adheres to all policies and procedures.
  • Performs other duties as assigned.


Qualifications/ Requirements:
  • A Bachelor’ s Degree from a four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
  • Training or experience in gerontology and/or hospitality is valuable
]]>
Thu, 04 May 2017 00:00:00 EDT 0
<![CDATA[Nursing Supervisor]]> Our client in Chicago is looking for a Nursing Supervisor to supervise staff engaged in delivering nursing services, such as conducting comprehensive assessments, taking vitals, interviewing prospective clients, and completing client admission forms and medical history.  Responsible for coordinating nursing processes and auditing medical records for accuracy.  Responsible for knowing intake and medical policies and procedures, and assures adherence to the same. Acts as liaison with physicians, psychiatrists and other medical professionals to assure appropriate care.

Job Responsibilities:
  • Interviews, hires, and oversees the training and development of staff.  Schedules, assigns work to, evaluates the performance of and, when necessary, applies appropriate discipline to staff.  Ensures compliance with established personnel policies and achievement of objectives for professional growth and development of staff.
  • Documents and charts client assessment data, medical needs, scheduled appointments, treatment plan, and so forth; transcribes physician orders. Audits medical charts to review comprehensive assessments. Ensures accuracy of diagnosis and care is appropriate to meet clients’ treatment and medical needs. Ensures records meet contractual requirements and comply with all local, state and federal laws.  Identifies and resolves discrepancies. Maintains confidentiality of records in accordance with established policies and procedures.
  • Assists medical consultants by setting up room and supplies for scheduled procedure, explaining procedure to clients and eliciting their cooperation, passing instruments and supplies, accepting and labeling specimens. Also reports client observations, evaluations of medical problems and potential barriers to achieving functional state of health to support recovery.
  • Serves as professional resource to nursing staff in evaluating unusually complex cases and devising appropriate treatment responses. Responsible for resolving management problems such interdepartmental barriers to delivery of care utilizing appropriate resources.
  • Assists in the development and implementation of policies and procedures related to medical services.  Interprets and enforces Gateway’ s overall objectives, as well as funding agencies policies and procedures; advises and assures adherence to same.
  • Assists in conducting initial health screenings and assessment of clients’ condition, and contributes information to aid in planning and evaluating care to meet identified medical needs.
  • Responsible for client medical case management which includes determining developmentally appropriate referral sources for clients requiring further medical, dental, or psychiatric diagnoses or treatment, and scheduling appointments; coordinating client transportation to scheduled appointments; conducting follow-up to ensure successful implementation of care plan and completion of necessary exams, tests and treatments; evaluating client response to treatments; instructing clients in self-care; and completing discharge plan summaries.
  • Performs triage of clients presenting symptoms, and performs both complex and routine treatments as prescribed by physician or as warranted by assessed condition, in accordance with established protocols.  Refers more complex injuries or illnesses to appropriate health care professionals
  • Administers or supervises client self-administration of medications as prescribed by physician.  Monitors clients for reactions, side effects, or contraindications; and confers as necessary with physician or pharmacist on withholding or continuing medications.  Contacts pharmacy to order prescribed medications.  Dispenses nonprescription medications as necessary and appropriate.
  • Conducts educational classes and seminars for clients and staff concerning health, treatment of medical issues related to substance abuse, sexually transmitted diseases, infection control, and so forth. Completes required documentation on class participation, progress and attendance.
  • Conducts annual tuberculosis testing, and maintains related records in compliance with all applicable governmental laws and regulations.
  • Maintains and enhances knowledge, expertise, and nursing skills through appropriate educational and organizational activities.
  • Participates in performance improvement activities as appropriate.


Qualifications/Requirements:
  • Advanced knowledge of theories, principles and concepts of nursing in order to contribute to the implementation of effective strategic plans and organization-wide programs at a level normally acquired through completion of a Bachelor’ s degree in Nursing.
  • Extensive knowledge of nursing principles in order to plan, evaluate, and provide expertise in the implementation and management of an effective nursing program.  Requires knowledge of Joint Commission requirements and standards; at a level normally acquired through two to four years of progressively responsible nursing experience, with at least one year experience in psychiatric and/or substance abuse field.
  • Current professional licensure as a Registered Nurse as required by the state. 
  • High level of problem solving and analytical abilities necessary to provide support to department in the development of complex systems and services for use in resolving problems requiring a comprehensive knowledge of nursing practices. 
  • Demonstrated skills and knowledge of the principles of physical growth and development and psychosocial development; the ability to assess and interpret client data and identify individual needs; to provide health-related care appropriate to the developmental stage and client population as outlined below:
    • Adolescent Clients: Ability to apply the principles of adolescent growth and development to an individualized treatment plan, e.g. understanding of sexual maturation, and its impact on the client’ s body image and self-esteem, demonstrating sensitivity to client’ s discomfort with aspects of the physical exam, familiarity with common health risks and concerns of adolescents, etc.
    • Adult Clients: Ability to apply knowledge of common health risks in adulthood as related to a history of substance abuse to teach and facilitate preventative health promotion.
    • Geriatric Clients: Ability to apply knowledge of the physical, cognitive, and psychosocial changes associated with later adulthood (e.g. multiple health issues, living with chronic pain, medication interactions, depression, cognitive deficits, etc.) to an individualized treatment plan; and to understand the impact of medications and medication interactions on the cognitive and behavioral functioning of the client.
  • Advanced interpersonal and communication skills necessary to provide leadership.  Ability to resolve frequently complex issues, to coordinate compliance and to successfully implement change.
  • Computer literacy in order to complete required records, reports and correspondence.
]]>
Wed, 03 May 2017 00:00:00 EDT 0
<![CDATA[Senior Manager, Clinical Operations and Development]]> My client is seeking a Senior Manager, Clinical Operations and Development. They will oversee clinical development programs (pre-IND through Phase 1-3 clinical trials). This key role will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans.  Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).  This position will report to the Associate Director of Clinical Operations.

Job Responsibilities:
  • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
  • Create, manage, and execute clinical operations programs, including study management, and budget and Gantt timeline creation
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
  • Co-monitor or monitor studies if needed for the program
  • Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
  • Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
  • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
  • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines


Qualifications/ Requirements:
  • Master’ s degree preferred in a scientific or healthcare discipline
  • Minimum of 6-8 years in clinical and drug development in the pharmaceutical/biotech industry, at least 3 years of direct study management work preferred
  • Understanding of drug development from pre-IND through NDA
  • Extensive experience managing clinical programs, CROs, budgets, and timelines required
  • Strong working knowledge of MS Project and developing Gantt charts
  • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
  • Management of CROs, multiple vendors, and complex protocols
  • Protocol, ICF, and CSR writing experience required
]]>
Tue, 02 May 2017 00:00:00 EDT 0
<![CDATA[R&D Program Manager / Sr. Program Manager - Late Stage]]> My client is seeking a talented, motivated, and goal-oriented individual to join a growing Program Management team. The successful applicant will play an important role in supporting drug development teams.  This individual will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific projects/programs, and to facilitate communication across all parties.   The ideal candidate will have a scientific background and experience with clinical-stage drug development.  This role is highly cross-functional, and may involve close interaction with external partners.

Job  Responsibilities:
  • Serve as project/program manager for one or more drug development teams, providing leadership, coordination, and cross-functional communication to enable teams to meet their goals;
  • Work with team members to compile high-quality, detailed, integrated cross-functional project/program plans, manage project activities, timelines, and resources;
  • Work with the project/program lead to facilitate decision making and resolve conflicts;
  • Work with the project/program lead and project/program team to identify key risks, timeline and resource constraints, and develop mitigation plans;
  • Effectively communicate project/program strategy, status, critical path activity timing, resource requirements, and related issues and/or risks, both internally and to partners, as appropriate;
  • Manage and maintain the team SharePoint site;
  • Effectively lead and manage team meetings by developing agendas, defining and communicating meeting objectives, capturing and disseminating meeting outcomes/information/minutes/action items, and following up on action item; 
  • Facilitate and contribute to the financial planning process, integrating inputs from functions and project/program teams into financial plans in collaboration with the Financial Planning & Analysis partners.
  • Help to create and improve program management tools and best practices.
  • Organize events to recognize team accomplishments.


Qualifications/ Requirements:
  • A 4-year degree and a minimum of 3-5 years of relevant work experience including some project or program management.
  • Late Stage drug development experience. 
  • Able to express ideas and present information clearly and effectively within teams, across functions, and with external partners.
  • Able to effectively lead team meetings and facilitate discussions within the team.
  • Demonstrate active listening and constructive feedback within team.
  • Ability to facilitate problem solving, decision making, and issue resolution.
  • Demonstrated analytical and technology skills, including proficiency in project planning tools, content management tools, and the Microsoft Office Suite.
  • Strong program management and organizing skills: 
  • Communicating across the organization to align on shared goals and responsibilities;
  • Working with teams to clarify vision and direction;
  • Developing work plans to meet goals;
  • Managing multiple projects at the same time;
  • Managing teams to meet goals and deliverables, tracking progress toward plan;
  • Highlighting areas of risk and developing mitigation plans;
  • Identifying options and facilitating decisions to enable projects to move forward;
  • Working with teams to develop budgets, and tracking progress towards plans;
  • Ability to plan and facilitate effective, efficient meetings, and prepare clear meeting minutes.
]]>
Mon, 01 May 2017 00:00:00 EDT 0
<![CDATA[Manager, Regulatory Affairs (Labeling)]]> This role is primarily responsible for assisting and managing the development of labeling. Assisting with the managing of key labeling systems and processes to support labeling development and approval at all stages of the product lifecycle is also required.

Success in the role is measured on:
  • Ensures all project timelines and regulatory commitments are met for labeling at all stages of the product lifecycle, and with no disruptions to commercial availability of marketed products. Will also need to drive measurable efficiencies and continuous improvements in the labeling processes.
  • No reworks, delays in launch or commercial availability or quality/regulatory impacts (recalls, etc.)
  • Ability to understand and interpret regulatory requirements, and translate this understanding into solid decision making.
  • Ability to work within a flexible framework to meet all regulatory requirements, CMO and business requirements/objections.


Job Responsibilities:
  • 60% - Develop or update submission, launch and/or post approval commercial labeling in accordance with NDA/ANDA project goals, FDA requests and responses or commercial/business needs. Ensure timely execution of shifting labeling priorities to balance all objectives and ensure all project timelines are met. Interfacing with CMO’ s and internal stakeholders may be required. Proofread all types of label copy/annotations/etc. at all development stages as well as final label copy, to ensure accuracy of labeling. Review and approve all levels of labeling to ensure all regulatory and GMP requirements are met. Provide project and labeling development process support.
  • 30% - Maintain quality systems used to support label development processes, including Label Master Index, Change Controls, File Management, NDC assignment and assessment, and SPL creation for drug listing, submissions, establishment registration and GDUFA. Daily work to include the review of dyelines, barcode creation and maintenance, shipper/DGFT labels, etc.
  • 10% - Create/revise SOPs, work instructions, and checklists accordingly


Qualifications/ Requirements:
  • College degree or equivalent experience required. Science background degree preferred (Biological, Chemistry, Pharmacy, Pre-Med, Nursing). Will also consider English, Journalism, Business, or Graphic Design degree.
  • 5 or more years of direct pharmaceutical labeling experience OR solid equivalent experience in cGMP environment (manufacturing preferred) OR quality OR regulatory submission.
  • 3 or more years’ experience in supervising staff.
  • Ability to work under deadline pressure/rapidly shifting priorities and manage multiple projects.
  • Ability to prioritize projects independently/experience working on project teams and leading teams.
  • Ability to drive projects to completion with minimal oversight.
  • Solid interpersonal communication skills (written and verbal) at all levels.
  • Supervisory experience.
  • Flexibility and strong negotiation skills.
  • Thrive in, and be able to work in, a fast paced entrepreneurial environment with broad responsibilities.
  • Possess a broad career progression including experience in multiple departments in pharmaceutical, drug development or manufacturing industry.
  • Have a passion for quality and an impeccable detail orientation.
  • Understanding of the labeling lifecycle and direct pharmaceutical labeling experience.
  • Understand context and content of label development.
  • Proficiency in proofreading and impeccable attention to detail.
  • Solid command of cGMP, FDA guidelines, and CFR labeling regulations/requirements required.
  • Knowledge of patent/exclusivity carve-outs.
  • Extensive experience in the use of PC- and Mac-based programs including Microsoft Office Word, Excel, Access, Adobe Acrobat Professional and Illustrator. Experience in document comparison software a plus.
  • Previous use of working in TrackWise and SharePoint desired.
  • Previous working knowledge of graphic design and the printing industry desired.
  • Knowledge of SPL creation and Drug Listing/Establishment registration submissions, labeler code requests, regulations and guidance’ s a plus.
  • Basic understanding of DSCSA/HDMA regulations a plus.
]]>
Wed, 26 Apr 2017 00:00:00 EDT 0
<![CDATA[Case Manager -Adult Addictions Unit]]> Our client in the Northern Suburbs is looking for a Case Manager on Adult Addictions Residential Unit. 

Job Description:
  • Provides case coordination and discharge planning services to patients and family
  • Assesses immediate and ongoing needs of patient
  • Provides acute behavioral/addiction interventions and offers recommendations for continued care
  • Prepares and updates care plan
  • Determines collateral supports, discharge needs, available resources, case coordination, psychosocial assessment, and family sessions, provides psycho-educational and clinical group therapy

Qualifications:
  • Masters Level Clinician (LCSW or LCPC) and CADC preferred
  • Knowledge of addiction
]]>
Wed, 26 Apr 2017 00:00:00 EDT 0
<![CDATA[RN]]> Our client in the Western Suburbs is looking for an RN:

Job Responsibilities:
  • Participate with members of the interdisciplinary team to review, plan, coordinate and evaluate resident’ s care. Documents the resident’ s condition and nursing needs accurately and in a timely manner. Reports pertinent observations and reactions regarding residents in a timely manner.
  • Oversee and provide leadership and discipline to licensed practical nurses and certified nursing aides. Develop, direct and monitor nursing assistant assignments adjusting based on census and level of care required. Communicate staffing problems and needs to supervisor. Escalate team member performance issues to supervisor; participate in counseling and disciplinary action to the extent permitted by the State Nurse Practice Act.
  • Execute treatments as necessary while document status and observes reactions to medications and treatments.
  • Generate, prepare, administrate and chart all medications.
  • Initiate physician orders, verify all orders received are transcribed accurately in electronic records and treatment plan, administer medications and provide treatments according to orders.
  • Facilitate communication with families regarding change in medications and/or changes in the resident.
  • Establish protocol to ensure care plans are continually reviewed for updated and accurate data that represents the individuality of the resident.
  • Coordinate admissions, discharges and transfers in order to deliver quality customer service.
  • Introduce an accurate and thorough report to the on-coming shift in order to ensure the continuity of maximum resident care.
  • Direct team members in emergency situations and contact appropriate parties as needed.
  • Orchestrate investigation, corrects and follows up on resident and family concerns as needed in a timely manner. 
  • Comply with applicable federal, state and local laws, rules, and regulations; maintains knowledge of and follows all company policies and procedures.

Job Qualifications:
  • Nursing diploma or associate’ s degree in nursing from an accredited nursing program is required. A Bachelor' s degree is preferred.
  • One year experience working in a long-term care facility.
  • Certifications and Registered Nurse license and other licensure required by state regulations
]]>
Tue, 25 Apr 2017 00:00:00 EDT 0
<![CDATA[MDS Coordinator]]> Our Client in the Western Suburbs is looking for an MDS Coordinator:

Job Responsibilities:
  • Organize and direct care plan meeting and achieve completion of MDS and Care Plans in a timely manner.
  • Institute all Federal mandated Medicare rules and regulations for admission and discharge eligibility.
  • Initiate admissions, quarterly, annually and significant changes in the MDS assessments in compliance with regulations and assures accuracy and completion of entire medical record.
  • Transmit MDS, holds weekly Medicare meetings and completed Medicare certs/re-certs.
  • Create PPS documents and prepare all Medicare requirements.
  • Regulate the encoding, editing, locking and transmitting of MDS’ s are within the required time frame.
  • Generate care plans that are appropriate to resident needs complete with measurable goals and individualized interventions.
  • Formulate and send the MDS scored and RUG categories to the billing office within the required time frames.
  • Deliver accuracy and completeness of the medical record including verifying physician orders for corresponding diagnosis.
  • Foster interactions with residents, families and nursing team members to ensure the care of the residents treatment plans are being delivered according to care plans, including all change in conditions.
  • Oversee resident’ s progress and identifies any significant changes that may require further assessment, change in RUG category or modification of the care plan.
  • Mentor nursing team as needed on areas of MDS and care plans.
  • Participates on committees and in meetings that impact the RAI process. (ie: Triple Check Meetings)
  • Generate “ CASPER” reports and regulatory oversight auditing tools and forward to the DON/NHA for QAPI process.


Qualifications/ Requirements:
  • Nursing diploma or associate’ s degree in nursing from an accredited nursing program is required. A Bachelor' s degree is preferred.
  • One year experience as a MDS Coordinator/ Registered Nurse Assessment Coordinator.
  • Certifications and Registered Nurse license and other licensure required by state regulations.
]]>
Tue, 25 Apr 2017 00:00:00 EDT 0
<![CDATA[Sr Clinical Budget Contract Coordinator]]> Significant growth and investment in R&D has created a new opportunity in the Contracts and Outsourcing team. Our client is seeking an  experienced Clinical Budget Contract Coordinator to work cross functionally with internal and external teams creating study agreement budgets for the company to be utilized globally.

Job Responsibilities:
  • Partner with R&D to build clinical study agreement budgets involving complex clinical protocols and academic center agreements.
  • Understand cost drivers associated with clinical study budgets along with a solid understanding of grant planning tools and/or ICD-10 codes.  
  • Responsible for the timely communication of issues to stakeholders that could impact project timelines.  Work closely with TA/FA' s, Legal, OEC and suppliers to resolve contract issues.
  • Demonstrates a high level of outsourcing and technical competencies across multiple contract types and therapeutic/functional areas.  Highly competent in negotiation and contracting business standards.


Qualifications/ Requirements:
  • BA/BS is required; Science degree is preferred but not required. 
  • Expertise with grant planning tools and/or ICD-10 codes and excel is highly preferred.
  • Minimum of 4 years of experience with 2 years of clinical budget experience.
  • Must have demonstrated ability in negotiation skills, project management skills and effective communication and relationship management abilities.  Contract budget experience in scientific setting is highly preferred.
  • Must have attention to detail along with an understanding of the quality/compliance environment.
  • Customer support focused expertise is highly desirable.
  • Critical Success Factors: The ability to manage internal and external relationships while balancing compliance requirements is a key success factor for this position.
  • Level of position is commensurate upon education and experience of the candidate.
]]>
Tue, 25 Apr 2017 00:00:00 EDT 0
<![CDATA[Associate Director, Regulatory Affairs]]> Our Client is a leading provider of infusion technologies. The company' s focused infusion systems portfolio features I.V. solutions, proven, innovative smart pumps, and pain management and safety software technology designed to help meet clinical, safety and workflow goals. 

We have an exciting opening in our Global Regulatory Organization for an Associate Director, Regulatory Affairs. In a highly visible and strategic role, the incumbent will lead the oversight for the US based team that supports global pharmaceutical marketed product portfolio from launch through market withdrawal globally. S/he will develop and implement global regulatory strategies to maintain existing registrations in compliance with applicable global regulations. As a key member of the leadership team, they will provide regulatory consult on Manufacturing Operations initiatives and derive innovative strategies to progress with Global Health Authorities.

Job Responsibilities:
  • Provide global regulatory impact assessment for changes to currently approved products in line with global regulations 
  • Define and implement regulatory strategies and priorities in support of changes to approved products 
  • Advise program/teams on regulatory requirements, coordinates and presents regulatory data needs, and negotiates with and influences management, colleagues and partners to ensure regulatory data requirements are met 
  • Manage the preparation and review of registration packages to ensure effective data presentation and quality 
  • Propose new/revised policies and recommend standard interpretation of global regulations 
  • Maintain an awareness of global legislation and assess its impact on the business and product development programs 
  • Create systems to assure regulatory compliance, and strives to ensure that products remain in compliance 
  • Manage the processes to achieve regulatory agency input 
  • Request, manage and facilitate agency meetings


Qualifications/ Requirements:
  • Ten years experience in the pharmaceutical industry as needed for the position, proprietary and/or biologics product development preferred. 
  • Minimum of five years experience in regulatory affairs, with a focus on biologic and/or proprietary drug development preferred. 
  • Experience working directly with regulatory agencies.   
  • Sound knowledge of applicable portions of global regulatory guidances and regulations. 
  • Excellent communications skills at all levels - both internally and externally. Strong interpersonal skills. Proven negotiating skills.  Strong management skills. 
  • Experience in contract manufacturing, development or other customer service related experience preferred.
]]>
Tue, 25 Apr 2017 00:00:00 EDT 0
<![CDATA[Home Health Weekend RN]]> Our client in the Western Suburbs is looking for a Weekend Home Health RN: 

Job Responsibilities:

  • Provides skilled nursing assessment upon admission to the agency at intervals specified by agency policy.
  • Provides treatments and procedures requiring special nursing skills.
  • Provides skilled nursing care to patients and families in the home setting, according to physician orders and agency policies and procedures.
  • Collaborates with the physician and other appropriate health care professionals in coordination with the patient and family members to develop and update the plan of care.
  • Implements home care services according to the plan of care.
  • Continually assesses patient’ s needs and alters plan of care when appropriate.
  • Coordinates all home health services provided with all members of the home care team as designated by the plan of care.
  • Observes, assesses, and communicates all pertinent clinical and psychosocial information to the physician, the supervisor and other health care team members as indicated through care coordination activities.
  • Initiates and updates home health aide assignment sheets.
  • Directs and supervises home health aide and LPN services.
  • Documents clearly and accurately in accordance with federal and state regulations, as well as agency and accrediting body standards.
    • Performs continuous record review according to agency policy.
    • Submits all required documentation in time frames specified by agency policy.
  • Communicates changes in patient status appropriately and timely.
  • Identifies needs for additional healthcare related services and makes appropriate referrals.
  • Provides patient/family teaching regarding disease process, infection control and prevention, home safety, medication regime and day to day management of the patient.
  • Counsels and educates patient and family in meeting nursing and related needs.
  • Participates in the on-call rotation as required.
  • Attends continuing education activities and maintains documentation of these activities.
  • Attends and participates in scheduled staff meetings.
  • Demonstrates personal commitment to the Mission Statement  by providing excellent healthcare and service that is professional, friendly, courteous and timely.
  • Participates in Continuous Quality Improvement (CQI) activities and other committees as requested.
  • Assists other team members when necessary.
  • Takes weekday and weekend day/evening/night call as assigned per rotation.
    • Performs on-call visits as directed
    • Performs phone triage as directed
  • All other duties as assigned.


Qualifications:
  • Current Registered Nurse (RN) Illinois State License
  • A minimum of one (1) year clinical experience
  • Home Health experience required
  • Computer skills adequate for data entry of clinical documentation
  • Current CPR certification
  • Current Illinois Driver’ s license and proof of current auto insurance
  • Must be able to read, speak and understand the English language
]]>
Tue, 25 Apr 2017 00:00:00 EDT 0
<![CDATA[Director Health and Wellness]]> Come do great things!   Director of Health & Wellness will direct  the memory care program ensuring high quality care, standards and state requirements for resident care are met.   In this role, you will direct  dedicated staff, ensuring  regulatory compliance and   manage a  budget.  This position reports to the Executive Director.

Responsibilities:
  • Directly oversees the delivery of care to memory care residents to ensure that emotional, physical, psychological and safety needs are met through all program services and activities.
  • Coordinates, along with the Executive Director, family/resident care conferences and serves as a direct liaison between residents, families, and staff.
  • Manages labor costs, supplies and other line items in budget.
  • Works with residents, families and other staff to ensure that residents are at appropriate levels of care.
  • Develops and/or monitors documentation systems to ensure that all regulatory time frames for review of assessments and service plans are met and that resident needs are met.
  • Ensures that employee tuberculosis testing is conducted in a timely manner.
  • Assesses potential residents for memory care level of care.
  • Schedules and conducts new resident orientation for all memory care residents.
  • Writes and reviews resident’ s assessments and care-plans with appropriate staff.
  • Plans and schedules staff training programs and in-services for the staff.
  • Ensures compliance with all state regulatory requirements including mandatory reporting to State.
  • Ensures that all concern and incident reports are completed, filed and that follow-up is conducted appropriately.
  • Manages and coordinates the work of all nursing and other assisted living staff, communicating pertinent resident health and safety information. 

Qualifications / Requirements:
  • A Bachelor’ s Degree from a four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
  • RN license 
 
      
]]>
Mon, 24 Apr 2017 00:00:00 EDT 0
<![CDATA[Director of Sales Training]]> As a Director of Sales Training for a national senior living corporation,  you will lead and develop the corporate  Sales and Marketing Training Department to drive increased occupancy and growth. You will train in person and virtually train sales team members, Executive Directors and other support staff on how to implement the corporate  Sales Systems within their respective senior living communities.  This position aids community sales leaders and managers in increasing occupancy, revenue, and investor return. 

The Director of Sales Training must embrace the  Sales System and demonstrate the ability to effectively coach and show the value of the  Sales System to trainees. It’ s important that the coach have the ability to stay focused on the  Sales Systems and tailor the coaching to the specific needs of the community they are working with.  The Sales Training Team will track the performance of the individuals they are coaching and provide performance/recommendations to the Regional and Corporate Teams.

Responsibilities:
  • Works closely with SVP of Sales and Marketing, National Director of Sales, and National Director of Marketing to develop Departmental Training.
  • Formulates teaching outline and determines instructional methods such as individual training, group instruction, lectures, demonstrations, conferences, meetings, and workshops based on the community sales need.
  • Coordinates training schedule, assigns trainings and tracks performance for new hires, focus communities, and individual team members as determined by SVP of Sales and Marketing and Vice Presidents of Operations.
  • Conducts training sessions covering specified areas.
  • Analyzes training needs to develop new training programs or modify and improve existing programs.
  • Achieves measurable training goals and benchmarks as determined by SVP of Sales and Marketing.
  • Tracks and demonstrates measurable results to demonstrate Return on Investment (ROI) of Sales Training programs.
  • Conducts surveys to gain feedback to continuously improve and enhance training program.
  • Analyzes and maintains  HR Policies & Procedures to ensure governmental compliance.
  • Communicates effectively with all levels of management, employees and outside contacts.
  • Maintain confidentiality of all pertinent information.
  • Possesses strong organizational skills and ability to multi-task and meet deadlines.
  • Interacts professionally and effectively with all levels of the organization, residents, family members, etc.
  • Travels extensively to communities.
  • Performs other duties as assigned.

Qualifications /  Requirements:

  • Bachelor' s Degree from an accredited university or equivalent work related experience in Communications, Marketing, Business, and/or Psychology

  • 5+ years experience in Sales, Marketing, and Training
  • Proficient in Microsoft Office Applications: Word, Outlook, Excel and PowerPoint as well as web based presentation software: Go to Meeting
]]>
Mon, 24 Apr 2017 00:00:00 EDT 0
<![CDATA[Sales Specialist]]> Various Senior Housing Sales Specialists / Troubleshooters needed for East, Central and West Division! 

This person is responsible for providing sales and marketing support to a community based on need and at the direction of the Corporate Director of Sales.  Accountable for assisting with lead generation and for closing sales and achieving/exceeding move in goals.  Maintains a positive image of the community with referral sources, residents, and staff personnel.  Immediate occupancy growth and revenue growth are the top two priorities and focus areas of this position. This person reports directly to the Corporate Director of Sales.

Responsibilities:
  • Schedules, organizes and conducts tours with prospective residents of independent and assisted living, memory care and skilled nursing.
  • Responds and follows-up with all walk-ins, phone inquiries and mail-ins timely and appropriately and treats each inquiry with value.
  • Creates, plans and implements with Sales and Marketing Team and Program Director events to bring in prospective residents such as but not limited to: seminars, speakers, themed events, and family nights.
  • Develops and maintains a good working relationship with residents, families, professional providers of care and all professional referral sources.
  • Maintains a working knowledge of all software programs.
  • Participates in weekend call coverage in Manager Rotation.
  • Capable of taking the lead with all sales that become uncertain, and instructing the individual assisting with the lead on immediate next steps and strategies.
  • Has the directive to challenge and question the Executive Director and other managers with regard to moving in and closing any sale effectively and timely. This also includes questioning any possible denials of admit or readmits.
  • Maintain confidentiality of all pertinent information.
  • Complies with all corporate policies, cities, state, and federal regulations pertaining to Residents’ accounts as it relates to Medicare, third party billing, etc.
  • Possesses strong organizational skills and ability to multi-task and meet deadlines
  • Interacts professionally and effectively with all levels of the organization, residents, family members, etc.

Qualifications /  Requirements:
  • Bachelor degree from a four-year college or university.  
  • Or one to two years’ experience and or training, or equivalent of education and experience.  
  • A solid track record of sales experience and success in the long term care industry and ability to build professional relationships.  
  • Exceptional verbal, written and organizational skills and computer proficiency required.  
  • Ability to travel up to 100% of time required.
]]>
Mon, 24 Apr 2017 00:00:00 EDT 0
<![CDATA[Director, Regulatory Affairs-Advertising and Promotion]]> Director, US Regulatory Advertising and Promotion will provide strategic support to the review of Advertising and Promotion materials in order to meet the US brand team' s objectives while ensuring the necessary level of regulatory compliance including meeting Office of Prescription Drug Promotion (OPDP) standards and internal policies.

Job Responsibilities:
  • Ensure that reviewed promotional Materials are (i) accurate, truthful and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures, including Global REG08 
  • Provide support for potential new product launches; promotional review of launch materials, implementation of OPDP advisory comment submissions and interactions with the Agency 
  • Work independently and recognize when issues need to be elevated to Senior Management 
  • Lead the development of and updates to the Approved Claims List 
  • Monitor and share with RC Members information on material regulatory developments and trends relevant to the RC generally, OPDP issues and a given promotional Material 
  • Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies  
  • Assist with the development of  policy and internal guidance 
  • Effectively communicate regulatory issues and concerns to senior governance group  including Marketing, Legal and Medical. 
  • Ensure business compliance and implementation of and adherence to Regulatory standards 
  • Regulatory review of any internal and external business communications 
  • Engage in appropriate activities in order to improve the regulatory environment through 
    Agency contacts: Office of Prescription Drug Promotion (OPDP) and trade associations as appropriate. 
  • Mentor newer staff members across the varied disciplines across multiple review 
    committees 
  • Enhance collaboration across a matrixed organization while developing and maintaining 
    constructive relationships


Qualifications/ Requirements:
  • BS or equivalent is required.  Science degree/advanced degree is preferred. 
  • 7 years or greater regulatory experience including significant Advertising & Promotion  expertise.  Launch experience a plus 
  • Demonstrable experience of effective delivery in complex matrix environment 
  • Strong negotiation and communication skills 
  • Experience interacting with FDA required: experience with OPDP preferred 
  • Level of the selected candidate will be determined based upon multiple factors including relevant education, overall experience, and prior track record
]]>
Mon, 24 Apr 2017 00:00:00 EDT 0
<![CDATA[Regulatory Affairs Manager]]> Our client’ s purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.

We currently have two positions open for a Manager, Regulatory Affairs in our clients Medical Device Division who will be responsible for new and existing combination products, disposable medical products and/or software driven medical devices.

Job Responsibilities:
  • Author US and international registrations (510(k)s, PMAs, CE Mark, etc) of stand-alone medical device software and/or combination products
  • Assess product changes to determine regulatory impact on existing product licenses. 
  • Perform gap analyses and propose solutions
  • Represent regulatory on assigned cross-functional product and project teams and establish regulatory strategies that align with world-wide objectives.
  • Act as regulatory project manager on assigned projects; interact with subject matter experts to help ensure on-time, quality documentation for regulatory filing; drive to expected regulatory timelines. 
  • Review and approve product labeling and advertising for compliance to applicable regulatory requirements.
  • Act as liaison for Business Unit RA to Country RA interactions
  • Use your regulatory point of view to support clinical investigations


Qualifications/Requirements:
  • Bachelor’ s degree or equivalent experience in related scientific discipline/ computer science/ medical device Regulatory Affairs
  • 5 years regulatory experience in the medical device industry
  • Experience with Authoring 510(k) submissions
  • Expertise with device regulations
  • Ability to manage complex projects and timelines in a matrix team environment
  • Strong oral and written communication (English), technical writing and presentation skills
  • The following experience is desired and a plus: combination of pharmaceutical, disposable medical devices, medical device software, and combination product experience; previous Experience in product development/regulatory submission for a Class III medical device or a combination product; Experience with regulatory requirements and knowledge concerning clinical investigations; Knowledge of US regulatory requirements for software driven medical devices, stand-alone software, and Medical Mobile Apps; Expertise with biocompatibility standards and regulatory aspects of material qualification; Experience in the design/development of networked database applications;   Knowledge of computer networking technologies and/or computer hardware components; Knowledge or experience with Cybersecurity and/or Computer System Security Concepts.
]]>
Thu, 20 Apr 2017 00:00:00 EDT 0
<![CDATA[Sr CRA - Texas - Houston/Dallas]]> Growing International CRO is building a US monitoring team.  Oncology or complex therapeutic area monitoring experience is required.  Monitoring regions are West Coast, East Coast and Texas near major airports.

Job Responsibilities:
  • Administration and full investigator site responsibility for clinical studies
  • May assume line management responsibilities for CRAs and assist PM as needed
  • Ensures clinical trials are monitored such that subjects' rights, safety and well-being are protected and that the clinical trial data are reliable.
  • Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
  • Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
  • Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities
  • Performs pre study visits
  • Performs initiation visits
  • Performs monitoring visits
  • Understands and updates Clinical Trial Management System (CTMS) in a timely manner
  • Monitors and updates data in an Electronic Data Capture (EDC) system
  • Demonstrates a broad understanding of the SAE reporting process to regulatory authorities
  • May write SAE narratives to support pharmacovigilance activities
  • Prepares accurate and timely visit reports from all types of visits
  • Assists in business development


Qualifications/ Requirements:
  • Graduate, postgraduate, 4-year college degree or equivalent, ideally in a scientific or healthcare discipline.
  • Three (3) years or more as Clinical Research Associate (CRA) either in Clinical Research Organization (CRO) or pharmaceutical industry.
]]>
Wed, 19 Apr 2017 00:00:00 EDT 0
<![CDATA[Director, Project Management (GAM)]]> The Director of Product Development (GAM) will manage all commercial activities for their assigned products.  The candidate will interface with Manufacturing, Logistics, Project Management, and Marketing for efficient product launches, accurate forecasting, and proper inventory levels.  The candidate will interface with Sales and Marketing to assess the market place for product launches.  This position is responsible for overseeing the execution of all product development activities from initiation of the project through product launch across all generic parenteral products on the market.   Directly responsible for managing all product development project budgets, plans and timelines to ensure development projects are submitted to the FDA on schedule, and approved products are launched on time and within budget.  Coordinates and runs team meetings, follows up to ensure team members are completing their deliverables on time.  Identifies activities that do not fall into specific departments and ensures they are completed. Maintains information in the project management database to ensure data is accurate and current.  

Success for this role would be measured primarily:
  • Number of exhibit batches and submissions to the FDA
  • Efficient product launches
  • Completion of all projects on schedule and within budget
  • Accurate maintenance of all project data in project database


Job Responsibilities:
  • Product launch coordination of activities to ensure launch occurs on schedule and within budget. Manage all information, run meetings and keep project teams informed of all product development activities (i.e. new codes, approvals of competing products, market trends and activities etc.). Manage responses to questions from other departments (i.e. Requests for forecasts, ASPs, Patent questions etc.)
  • Work with partners and internal project teams to ensure development projects are submitted to the FDA and launched on time. Ensure deficiencies are submitted to the FDA in a timely manner 10% - Once API is identified, work with business development and vendors to secure API
  • Work with business development to support securing new proposals for new projects.
  • Monitor new projects available with partners.


Qualifications/ Requirements:
  • Bachelor of Science degree required. Advanced degree preferred - Masters (MBA) OR PhD.
  • Project Management certification preferred or equivalent formal project management experience.
  • Commercial marketing background or training a plus.
  • 7 or more year’ s pharmaceutical industry experience with a broad career progression in the commercial, development, approval and/or manufacturing of new pharmaceutical products.
  • Familiarity with GMP, regulatory affairs, logistics, QA, or pharmaceuticals manufacturing
  • Strong project and/or product management experience required. Project Management certification a plus.
  • 3 or more years’ experience direct report supervisory experience required as well as ability to manage indirect relationships and projects successfully. Experience supervising pharmaceutical drug development staff a plus. .
  • Strong interpersonal communication skills required – verbal, written and presentation.
  • Willing to travel domestically or internationally as needed.
  • Knowledge of the Pharmaceutical industry product development, manufacturing and approval process
  • Familiarity with basic understanding of FDA requirements, GMP requirements and product approval activities and timelines 
  • Strong project / product management experience including forecasting, budgeting and project planning
  • Experience developing, cultivating and managing internal and external relationships with people at all levels of management.
  • Solid problem solving, data analysis and decision making skills
  • Solid computer skills – proficiency with Excel, Word and Outlook.
  • Able to see beyond the obvious to mitigate risk - assess and anticipate potential problems and outcomes, facilitate decision making, problem resolution using strong negotiation skills.
  • Cross cultural competency – experience working with global suppliers or working internationally in another country required.  Understanding of how to communicate with, negotiate with and manage people and projects in other countries (China and India preferred) required.   
  • Ability to lead, mentor, and develop others for future growth and development.
  • Able to work in a cross-functional, matrix team environment with a flexible team-oriented perspective.
  • Thrives in a rapidly changing, fast paced, entrepreneurial and growth oriented business culture.  
  • Strong interpersonal skills including verbal and written communication.
  • Able to negotiate with partners to assure deliverables and expectations are met in a timely manner.
  • Ability to oversee multiple and competing projects in a fast-paced, changing team environment.
]]>
Wed, 12 Apr 2017 00:00:00 EDT 0
<![CDATA[Tax Manager]]> Reporting to the Tax Director, the Tax Manager will be involved with all facets of the corporate tax function and will play a critical role by providing analytical and technical support to the Tax Director.

Job Responsibilities:
  • Prepare and review quarterly and annual tax provision per ASC 740 with assistance from tax staff accountant.
  • Prepare tax footnote and related tax disclosures required for a public company.
  • Review and coordinate preparation of Federal and State income tax returns with outside firm.
  • Act as liaison with business units to gather necessary data to provide outside firm for the completion of income tax returns.
  • Participate in annual R&D credit project, documentation, and analysis.
  • Manage Federal, State and local income tax examinations.
  • Resolves tax issues, and provides guidance to tax accountant in responses to tax notices and inquiries from federal/state agencies.
  • Ensure SOX compliance and coordinate documentation evidencing internal controls have been followed.
  • Research complex tax issues and identify tax planning opportunities.
  • Improve and implement tax department processes and standard work to reduce provision and compliance cycle times.
  • Mentor and develop tax staff accountant.

Job Requirements:         
  • Bachelor' s Degree in Accounting.
  • CPA or advanced degree in Tax is required.
  • 4+ years of experience in tax including experience in public accounting
  • Demonstrated knowledge and experience in ASC 740.
  • Experience in tax provision software, preferably OneSource.
  • Ability to work well in a high energy and multi-tasking environment with ability to meet tight timelines.
  • Understanding of business in a Lean organization preferred
  • Strong communication skills (written, verbal and presentation)
  • All associates must embrace and foster an environment that supports our core values of Integrity, Respect, Excellence, Teamwork and Accountability. Offers a competitive salary package in addition to a comprehensive benefits package including Medical, Dental, Vision, 401(k) with Company Match and Flexible Spending Accounts.
]]>
Tue, 11 Apr 2017 00:00:00 EDT 0
<![CDATA[Controller]]> The Controller is responsible for planning, forecasting, analysis, management reporting, accounting operations, and internal controls and compliance for the Mechanical sales division. In addition, the Controller supports the VP and General Manager, providing support on matters relating to the performance, capital and other resource allocation decision analysis, and financial processes for the Mechanical business. The Controller will interact closely with sales, supply chain, and plant operations. In addition to financial process and performance management, the Controller will contribute and in some areas provide leadership in strategic initiative deployment. The Controller will interact with the Corporate Accounting and External Reporting department to continuously improve accuracy, timeliness, and quality of financial reporting, as well as with corporate Financial Planning and Analysis to improve and maintain forecasting and reporting processes.

Job Responsibilities:
  • Provide sound financial analysis, financial planning tools and economic decision making support to the business leader and their management team. Key areas of focus include pricing, revenue and gross margin, selling and administrative expenses, working capital and other key performance indicators (KPI’ s).
  • Lead and develop one to two direct reports.
  • Execute monthly financial close process, including generation of internal financial statements, loading financial results into the financial reporting system, preparing and reviewing data for journal entries, performing and reviewing account reconciliations, and account analysis.
  • Prepare a comprehensive monthly financial package to be reviewed with the VP & Controller - Mechanical Products & Solutions as well as the President of the Mechanical Products and Solution business.
  • Manage the process and prepare the monthly forecast, including consolidation and analysis of inputs from the sales, manufacturing and support functions.
  • Manage the process and prepare the annual budget in a manner that drives and supports the strategic imperatives of the business and ensures alignment to the plan across all business functions.
  • Convert monthly, quarterly, and annual financial data into understandable summaries in order to drive recommendations and actions by the individual and leadership team.
  • Participate in key business initiatives, prepare “ what if” scenarios on certain business levers, and perform benchmarking and other ad-hoc projects, as necessary.
  • Maintain ownership of documenting and ensuring SOX and internal compliance with control standards for the business unit. Develop relationships with internal and external audit partners and support the internal and external audit processes.
  • Lead and proactively drive business process changes to eliminate waste and improve accuracy.
  • Work as a member of the team with other finance leaders and support global finance initiatives.
  • Demonstrate and promote our key values of Integrity, Respect, Excellence, Teamwork and Accountability through actions and decisions.


Qualifications/ Requirements:
  • Bachelor’ s Degree in finance or accounting. CPA or MBA a plus.
  • Finance/ accounting experience of minimum of 10 years’ experience with increasing responsibility in a sales/distribution or manufacturing company
  • Solid understanding of US GAAP required
  • Strong problem solving and analytical skills with attention to detail
  • Excellent communication skills (both written and oral)
  • Interpersonal skills allowing for a challenging and constructive engagement with all management levels of the organization
  • Capacity to perform at a high level in a fast paced, multi-tasking environment
  • Cross-cultural sensitivity and ability to act with integrity and respect
  • Experience with JDE and Hyperion a plus
  • Proficient knowledge of MS Office with expert level Excel skills
]]>
Tue, 11 Apr 2017 00:00:00 EDT 0
<![CDATA[RN/LPN]]> Our client in the Northern Suburbs is looking for an RN or Licensed Practical Nurse:

Job Responsibilities:
  • Administers, or supervises client self-administration of medications according to nursing policy and procedure, and as prescribed by physician.  In doing so, measures or counts required dosage, selects and sterilizes appropriate injection site, and documents administration in client chart.  Notifies appropriate medical or nursing personnel of contraindications, and withholds further medications until otherwise directed.
  • Assists in conducting initial health screenings and assessment of clients’ condition, and contributes information to aid in planning and evaluating care to meet identified medical needs.
  • Provides direct technical nursing care and performs treatments according to physician orders or established protocols and nursing policies.  Such treatments could include applying compresses or bandages, cleansing or irrigating wounds, changing dressings, and so forth.
  • Conducts triage of clients presenting symptoms or complaints, and performs treatments for minor illnesses or injuries according to established protocols.  Refers more complex injuries or illnesses to appropriate health-care professionals.
  • Charts clients’ vital signs, symptoms, reactions and progress; as well as developmentally appropriate treatments performed, nursing care received, and other information pertinent to assessment, planning, and evaluation of clients’ medical needs and care.
  • Schedules client appointments for diagnostic procedures, treatments, or follow-ups as instructed.
  • Assists physicians with examinations and treatments.  Prepares client and examination room according to scheduled procedure; obtains and passes instruments, equipment and supplies, and performs other tasks as requested.
  • Depending on program assigned, performs variety of related technical or administrative duties such as maintaining infection control log and assisting in surveillance clarification when needed; conducting standard client education classes concerning HIV, sexually transmitted diseases, or tuberculosis; or assuming on-call responsibility as assigned.
  • Maintains work, storage, and client care areas in neat and orderly condition.  Requisitions approved supplies, and ensures proper storage and security of inventory and equipment.
  • Participates in performance improvement activities as appropriate.


Qualifications/ Requirements:
  • Knowledge of nursing treatment, planning and assessment as acquired through completion of twelve to eighteen months post-high school training at an approved, accredited school of practical or vocational nursing; as well as successful completion of pharmacology coursework necessary to administer medications.
  • Current state license as a Practical Nurse.
  • Demonstrated skills and knowledge of the principles of physical growth and development and psychosocial development; the ability to assess and interpret client data and identify individual needs; the ability to communicate and to provide health-related care appropriate to the developmental stage and client population as outlined below:
    • Adolescent Clients: Ability to apply the principles of adolescent growth and development to an individualized treatment plan, e.g. understanding of sexual maturation, and its impact on the client’ s body image and self-esteem, demonstrating sensitivity to client’ s discomfort with aspects of the physical exam, familiarity with common health risks and concerns of adolescents, etc.
    • Adult Clients:  Knowledge of common health risks in adulthood as related to a history of substance abuse.
    • Geriatric Clients:  Knowledge of the physical, cognitive, and psychosocial changes associated with later adulthood (e.g. multiple health issues, living with chronic pain, depression, cognitive deficits, etc.) and to understand the impact of medications and medication interactions on the cognitive and behavioral functioning of the client.
  • Ability to work under minimal supervision in administering medications, conducting assessments, and performing treatments; and knowledge of health problems related to substance abuse and recovery; at a level normally acquired through one to two years related experience.
  • Interpersonal skills necessary to interact with clients, families, staff and physicians; and to demonstrate empathy and sensitivity necessary to elicit clients’ cooperation and minimize apprehensions.
  • Analytical abilities necessary to gather and interpret assessment data, provide treatment in accordance with established protocols, complete necessary documentation, and determine need for appropriate referrals.
]]>
Tue, 11 Apr 2017 00:00:00 EDT 0
<![CDATA[Manager, Regulatory Affairs- Combination Products]]> Our client is a leading provider of infusion technologies. The company' s focused infusion systems portfolio features I.V. solutions, proven, innovative smart pumps, and pain management and safety software technology designed to help meet clinical, safety and workflow goals. 

We have an exciting opening for a Manager, Regulatory Affairs supporting our clients robust Combination Products portfolio in Lake Forest, Illinois. Join us and propel your career in a global setting. 

In a key and highly visible role, this individual will act as the regulatory core team member for, and provide regulatory guidance to combination product project teams in a fast paced, highly visible, complex, and at times ambiguous and changeable environment.

Job Responsibilities:
  • Responsible for the creation of all submission documentation for a project with a large portfolio of products.  This includes correspondence, meeting requests and dossier content, including labeling 
  • Set and communicate timelines for the regulatory submissions and for the delivery of supporting documentation.  Must work with all functional areas to obtain needed information on time    
  • Anticipate the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and influence the team as needed.  
  • Review scientific information to ensure the data is complete, sound, logical, and supports the program goals.  Must be able to work with authors to ensure supporting information is clearly and logically written, in order to ensure it is submission ready  
  • Exquisite attention to detail is required to ensure alignment both within and between dossiers for large portfolio projects, both the incumbent’ s and those of colleagues 
  • Able to handle multiple projects of various complexities (very simple to very complex) simultaneously and meet the project goals 
  • May provide guidance to others on the creation of labeling or dossier contents.  May approve labeling. 
  • Interact and effectively negotiate with regulatory authorities 
  • Maintain awareness of applicable regulations and guidances and informs project teams of new information, along with its possible impact to the project, as appropriate. 
    Interprets regulations and ensures regulatory compliance 
  • Exercises good judgment within company policy and health authority regulations.


Qualifications/ Requirements:
  • Bachelor’ s degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject is required. Masters is preferred; Ph.D is highly preferred 
  • Minimum 5 years of experience in either pharmaceutical or device regulatory affairs, preferably both. Be able to quickly learn the other discipline if inexperienced.  Must quickly become effective in both disciplines 
  • Excellent written and interpersonal communication skills.  Must be able to present all information (regulatory and scientific) effectively, both orally and in writing, in a concise, logical, and persuasive manner 
  • Understand the intent of the regulations to wisely navigate the discrepancies that exist in the application of each set of regulations to combination products, in order to ensure the decisions work well throughout the lifecycle of the products and to set appropriate precedent for future products and projects 
  • Previous experience with combination product regulatory strategy and/or execution is beneficial
]]>
Mon, 27 Mar 2017 00:00:00 EDT 0
<![CDATA[Director Clinical Pharmacology, Medical Science]]> Our client is seeking a Director Clinical Pharmacology, Medical Science that will oversee the direction, planning, and execution of clinical pharmacology programs and the interpretation of clinical pharmacology data.

The Director Clinical Pharmacology will be accountable for the clinical pharmacology strategy for assigned development programs and study design, and will be responsible for clinical pharmacology study synopsis and protocol development in compliance with the clinical development plan. To be successful in this role, the individual will be self-motivated, able to work well in cross-functional teams, and must have a strong work ethic and integrity. This role reports to the Senior Medical Director, Medical Science.

Job Responsibilities:
  • Overall accountability for the clinical pharmacology strategy for each assigned program, the design and implementation of clinical pharmacology studies, the writing clinical study synopses and protocols/major amendments, the design of data collection systems and the preparation of final clinical study reports.
  • Represents Clinical Pharmacology on assigned Clinical Sub Teams, providing clinical pharmacology input to the clinical development plan.
  • Represents Medical Science/Clinical Pharmacology on assigned Study Management Teams, providing medical input to overall clinical pharmacology study planning and implementation.
  • Responsible for directing human clinical pharmacology trials, Phases I– IV, for company products under development.
  • Responsibilities also include adverse event reporting and safety management, under the direction of the Patient Safety Department.
  • Coordinates and develops information for reports submitted to regulatory authorities. Authors appropriate regulatory documents including clinical pharmacology sections of CTD format documents.
  • Monitors adherence to protocols and determines study completion.
  • Develops positive and productive relationships with investigators and KOLs for the design of clinical pharmacology trials and programs, and with CROs and DMPK colleagues internally.
  • Overall responsible for the assessment of benefit/risk with the Medical Science Director and Patient Safety Department.
  • Ability to manage external organizations.
  • Provide clinical pharmacology leadership on assigned Clinical Sub Teams and medical leadership within assigned Study Management Teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations is essential.


Qualifications/ Requirements:
  • Medical degree with at least two years’ bio/pharmaceutical industry drug development experience in clinical pharmacology
  • Knowledge of Neurology, Anesthesia and/or Psychiatry drug development or clinical experience as a Neurologist or Psychiatrist is strongly preferred.
  • Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues
  • Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CRO.
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Mon, 20 Mar 2017 00:00:00 EDT 0
<![CDATA[Licensed Practical Nurse]]> Our client in the Northern Suburbs is looking for a Licensed Practical Nurse:

Job Responsibilities:
  • Administers, or supervises client self-administration of medications according to nursing policy and procedure, and as prescribed by physician.  In doing so, measures or counts required dosage, selects and sterilizes appropriate injection site, and documents administration in client chart.  Notifies appropriate medical or nursing personnel of contraindications, and withholds further medications until otherwise directed.
  • Assists in conducting initial health screenings and assessment of clients’ condition, and contributes information to aid in planning and evaluating care to meet identified medical needs.
  • Provides direct technical nursing care and performs treatments according to physician orders or established protocols and nursing policies.  Such treatments could include applying compresses or bandages, cleansing or irrigating wounds, changing dressings, and so forth.
  • Conducts triage of clients presenting symptoms or complaints, and performs treatments for minor illnesses or injuries according to established protocols.  Refers more complex injuries or illnesses to appropriate health-care professionals.
  • Charts clients’ vital signs, symptoms, reactions and progress; as well as developmentally appropriate treatments performed, nursing care received, and other information pertinent to assessment, planning, and evaluation of clients’ medical needs and care.
  • Schedules client appointments for diagnostic procedures, treatments, or follow-ups as instructed.
  • Assists physicians with examinations and treatments.  Prepares client and examination room according to scheduled procedure; obtains and passes instruments, equipment and supplies, and performs other tasks as requested.
  • Depending on program assigned, performs variety of related technical or administrative duties such as maintaining infection control log and assisting in surveillance clarification when needed; conducting standard client education classes concerning HIV, sexually transmitted diseases, or tuberculosis; or assuming on-call responsibility as assigned.
  • Maintains work, storage, and client care areas in neat and orderly condition.  Requisitions approved supplies, and ensures proper storage and security of inventory and equipment.
  • Participates in performance improvement activities as appropriate. 


Qualifications/ Requirements:
  • Knowledge of nursing treatment, planning and assessment as acquired through completion of twelve to eighteen months post-high school training at an approved, accredited school of practical or vocational nursing; as well as successful completion of pharmacology coursework necessary to administer medications.
  • Current state license as a Practical Nurse.
]]>
Mon, 13 Mar 2017 00:00:00 EDT 0
<![CDATA[Nurse Supervisor]]> Our client in Chicago is looking for a Nursing Supervisor.

Job  Description:
  • Supervising staff engaged in delivering nursing services
  • Conducting comprehensive assessments, charting vitals, completing admission forms, and documenting medical history
  • Auditing medical records for accuracy of diagnosis and care
  • Ensuring compliance with contractual requirements, established policies and procedures, and applicable regulations
  • Evaluating complex cases and working with clinical treatment team to devise appropriate treatment response
  • Acting as liaison with physicians, psychiatrists, and other medical professionals to assure appropriate care
  • Other duties as assigned

Job Requirements:
  • Current license as a Registered Nurse in the state of IL
  • Bachelor’ s degree in Nursing preferred
  • Minimum 5 years of work experience as a RN in a social service environment or related field required
  • Minimum 1 year of supervisory experience required
  • Concurrent experience with relevant client population (adult, youth or outpatient) preferred
  • Ability to work Monday-Friday day shift

 

 
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Mon, 13 Mar 2017 00:00:00 EDT 0
<![CDATA[RN]]> Our client in the Western Suburbs is looking for a Home Health RN.

Job Responsibilities:
  • Provides skilled nursing assessment upon admission to the agency at intervals specified by agency policy.
  • Provides treatments and procedures requiring special nursing skills.
  • Provides skilled nursing care to patients and families in the home setting, according to physician orders and agency policies and procedures.
  • Collaborates with the physician and other appropriate health care professionals in coordination with the patient and family members to develop and update the plan of care.
  • Implements home care services according to the plan of care.
  • Continually assesses patient’ s needs and alters plan of care when appropriate.
  • Coordinates all home health services provided with all members of the home care team as designated by the plan of care.
  • Observes, assesses, and communicates all pertinent clinical and psychosocial information to the physician, the supervisor and other health care team members as indicated through care coordination activities.
  • Initiates and updates home health aide assignment sheets.
  • Directs and supervises home health aide and LPN services.
  • Documents clearly and accurately in accordance with federal and state regulations, as well as agency and accrediting body standards.
    • Performs continuous record review according to agency policy.
    • Submits all required documentation in time frames specified by agency policy.
  • Communicates changes in patient status appropriately and timely.
  • Identifies needs for additional healthcare related services and makes appropriate referrals.
  • Provides patient/family teaching regarding disease process, infection control and prevention, home safety, medication regime and day to day management of the patient.
  • Counsels and educates patient and family in meeting nursing and related needs.
  • Participates in the on-call rotation as required.
  • Attends continuing education activities and maintains documentation of these activities.
  • Attends and participates in scheduled staff meetings.
  • Demonstrates personal commitment to the Mission Statement  by providing excellent healthcare and service that is professional, friendly, courteous and timely.
  • Participates in Continuous Quality Improvement (CQI) activities and other committees as requested.
  • Assists other team members when necessary.
  • Takes weekday and weekend day/evening/night call as assigned per rotation.
    • Performs on-call visits as directed
    • Performs phone triage as directed
  • All other duties as assigned.

Job Qualifications:
  • Current Registered Nurse (RN) Illinois State License
  • A minimum of one (1) year clinical experience
  • Home Health experience required
  • Computer skills adequate for data entry of clinical documentation
  • Current CPR certification
  • Current Illinois Driver’ s license and proof of current auto insurance
  • Must be able to read, speak and understand the English language
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Mon, 13 Mar 2017 00:00:00 EDT 0
<![CDATA[Director of Home Healthcare]]> Great healthcare organization seeking a Director of Home Healthcare for the greater Chicagoland area! This Director will have administrative responsibility for the provision of all home health services, ensuring quality, efficiency and the safe appropriate delivery of care. 

This position  offers a competitive salary, mileage reimbursement, smart phone, laptop and full benefits including PTO, medical, dental, vision, STD, 401(k) with match, life insurance, AD&D; and tuition reimbursement.

Job Responsibilities:
  • Responsible for directing services with the highest professional standards in accordance with agency policies, procedures, philosophy, mission statements and compliance with all applicable state/federal and local regulations.
  • Develops and coordinates implementation of agency approved policies and procedures that establish standards of care and communicates changes to staff and contracted providers.
  • Evaluates the effect of in-service and continuing education programs. Acts as a liaison by developing and maintaining relationships by representing agency to physicians, hospitals, and other community agencies to provide for continuity of care and assure availability of services presented to the public are appropriately provided by the agency.


Qualifications/ Requirements:
  • Licensed as a Registered Nurse in the State of Illinois.
  • Bachelor’ s Degree required.
  • 3-5 years of progressive management experience required.
  • 3-5 years of home healthcare and/or private duty experience required.
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Mon, 06 Mar 2017 00:00:00 EST 0
<![CDATA[Medical Reviewer/Safety Reviewer - C]]> Our client is in search of a Medical Reviewer/Safety Reviewer to join their team in the northern Chicago area.

Job Responsibilities:
  • Reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols.
  • Triages SAE information in order to fulfill timely reporting according to the authority/regulatory requirements. Participates in applicable safety surveillance activities for assigned products. Collects, analyzes, and triages AEs including reporting SAEs to IND safety. Assessment of AE coding for consistency and accuracy of coding.
  • Medical review of safety-related CRFs and labs, including communication with Study Physicians. Interface with study manager, CROs, CRAs, Data Management, PV to assure query resolution.
  • Creation of narratives of SAEs and other identified AEs of interest in accordance with accepted standards and with minimal revision required upon review.

Job Qualifications:
  • MUST BE AN RN.
  • 3-5 years of clinical experience is required.
  • Computer proficient (Windows, Word, Excel).
  • Able to present adverse event data, orally and in writing.
  • Pharma experience recommended.
  • Broader knowledge of ICH/FDA regulations and guidelines affecting drug safety issues preferred.
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Tue, 28 Feb 2017 00:00:00 EST 0
<![CDATA[Clinical Operations Nurse]]> Our client in the Western Suburbs is looking for a Clinical Operations Nurse.

Job Responsibilities:
  • Participate in survey education and quality spot review process in assigned facilities as scheduled.
  • Implement follow-up in facilities in response to mock survey results.
  • Review incidents/occurrences and monitor for appropriate follow-up documentation and interventions; analyze incidents for trending and determination of further clinical needs.
  • Obtain significant occurrence documentation and submit to the VP of Risk Management.
  • Provide clinical information on legal claims as needed.
  • Collaborate with the other Clinical Operations Nurses, VP of Clinical Operations, VP of Risk Management and Quality Assurance, to review company trends related to resident incidents and develop proactive interventions and programs to reduce company risk.
  • Identify necessary educational opportunities which would benefit the facility staff opportunities to the Director of Training and Development and determine appropriate action plans.
  • Provide education and staff competencies in support of action plans.
  • Utilize Quality Improvement tools to evaluate resident outcomes, and staff performance and behaviors.
  • Manage most of the IDPH process; a) reviewing the Plan of Correction(POC) b) setting an appropriate date of completion for the POC c)reviewing the evidence of compliance d) monitoring for IDPH feedback and working with Royal Clerical Support on calendar time frames for compliance e) obtain necessary documentation for the Informal Dispute Resolution (IDR) process.
  • Conduct chart reviews as necessary and review areas of risk with the appropriate personnel.
  • Partner with the facility Director of Nursing and provide guidance as necessary in meeting resident needs.
  • Assisting other team members when necessary

Job Requirements:
  • Bachelor' s Degree preferred.
  • A team-focused, experienced Registered Nurse, RN, with 3+ years Director of Nursing experience in a long term care facility.
  • Strong communications skills.
  • Knowledge of state and federal regulations.
  • Ability to multi-task and prioritize.
  • Demonstrated ability to critically analyze data and provide guidance to the facility on an appropriate plan.
  • Must be able to read, speak and understand the English language.
  • Must have the ability to sit, stand, walk, stoop and reach, and to use hands to manipulate the computer, writing, calculation or other instruments to carry out responsibilities of the position.
  • Must be able to lift objects up to 20 pounds.
  • Must have adequate vision to perform essential job functions.
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Tue, 28 Feb 2017 00:00:00 EST 0
<![CDATA[Manager/Associate Director Medical Writing]]> Our client is searching for a creative, resourceful, integrative thinker for a role that is responsible for managing medical writing vendor(s), documents, and reviews for clinical and regulatory documents (protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. 

This position will function under the guidance and direction of the Head of the medical writing department.  The successful candidate will be an independent, proactive, experienced medical writer with experience in preparing key summary submission documents (eg, Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview), and demonstrated experience managing the project work of other outsourced medical writers. 

Job  Responsibilities:
  • Work with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator brochures, etc., according to company and agency guidelines in order to support drug development under strict timelines.
  • Be hands on and also manage the work of other medical writers (mostly through a strategic partner and possibly internal in the future) to prepare documents. This includes training and mentoring in addition to participation in assessing workload and managing work assignments.
  • Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient production and publishing of documents and dossiers.
  • Ensure a consistent style of presentation of documents to maintain quality and ease of review.
  • Contribute to the design and maintenance of templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices.
  • Represent Medical Writing on cross-functional teams.
  • Collaborate with and support the department leadership to ensure continuous improvement, and high standards for quality and productiveness.


Qualifications/ Requirements:

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills.        
  • Candidate must have a BS or equivalent in a biological science.  An advanced degree, particularly in neuroscience, psychiatry, or related field is ideal.
  • Candidates must have at least 7 years of experience as a medical writer.   Exceptional candidates with less direct medical writing experience but considerable transferrable experience or skills may be considered.
  • Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
  • Detailed knowledge of requirements for preparation of key clinical and regulatory documents.
  • Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
  • Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment.
  • Demonstrated problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to independently complete high-quality documents according to tight timelines.
  • Experience in successfully resolving conflicting editorial opinions expressed by team members. 
  • Demonstrated experience mentoring and managing the project work of other medical writers.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
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Tue, 21 Feb 2017 00:00:00 EST 0
<![CDATA[Clinical Data Coordinator - B]]> Our client is in search of  Clinical Data Coordinator to join their team in the northern Chicago area. 

Job Responsibilities: 
  • Central “ Point of Contact” for all Clinical Supply Management System related matters. Receives all support calls related to the system or any of the connected systems / reports / interfaces.
  • Determine issue criticality and identifies next steps.
  • Responsible for Master Data management
  • Resolve error messages received through the system interfaces
  • Assist in SOP development and maintain business practices
  • Perform or Assist in System Training Activities
  • Perform report development and implementation of non- validated reports

Job Qualifications/Requirements: 
  • Bachelor’ s Degree or equivalent experience
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Wed, 08 Feb 2017 00:00:00 EST 0
<![CDATA[Clinical Research Associate (CRA) - C]]> Job Responsibilities:
  • Assist the Study Project Manager on study related activities for one or more studies. Coordination of study activities for a cross-functional team during the initiation, conduct and close-out of one or more clinical studies. Activities to include: study design, protocol preparation, investigator selection, investigator meeting planning, contract preparation, vendor selection, CRF design, development of monitoring plan and other activities to ensure on time completion of studies.
  • Identify site issues that potentially impact study data, study conduct and ICH compliance. Escalate issues and make recommendation for corrective action.
  • Assist with vendor management of CROs, Central Labs, Central Imaging and other suppliers. Perform review and approval of site and vendor invoices.
  • Assist Medical Writing with statistical table review and QC
  • Plan and track study progress for adherence to timelines
  • Experience with EDC is required and should include the review of data listings and query resolution
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures

Qualifications/Requirements: 
  • 3 - 5 yrs experience
  • Experience with EDC is required
  • Safety review experience preferred
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Wed, 08 Feb 2017 00:00:00 EST 0
<![CDATA[Senior Case Manager]]> Opportunity to take the next step in your career toward leadership as a Sr.  Case Manager role with a community-focused hospital in Chicago!   This position will be the right-hand person to the Director of Case Management!

Job Responsibilities:
  • Responsible for all business related issues at admission or first encounter with the facility to include obtaining all initial authorization and notifications to health plans including OP surgical procures, review for appropriateness of IP admission and discharge criteria according to level of care ordered, facilitate concurrent core measure early recognition and compliance by physicians and nurses, and document all authorizations.
  • Partner with Director on team member evaluations and performance.
  • Serve as coach / educator / trainer to the team on best practices, policies, procedures and regulations.
  • Prepares staffing plans and schedules.
  • Collects, analyzes and reports a variety of data requested by the department.
  • Demonstrates the Customer Service Values, which are key in providing quality service to patients and customers. 
  • Communicates with the care Management Team, physicians, and nurses to appropriately determine appropriate care setting upon admission to the hospital setting.  Clinical knowledge is used to determine appropriate care setting which are determined in part based on identified patient population and acuity/severity of illness at the time of admission.


Qualifications/ Requirements:
  • Current Illinois Registered Nurse required.
  • BSN (Masters preferred)
  • CPR Certification
  • Previous Case Management experience in a hospital setting 
  • CCM or ACM preferred
  • Experience with Insurance Verification and Pre-authorization preferred.
  • Knowledge of Admissions and Discharge Criteria for all Insurance Types including Medicare/Medicaid,/Third Party/Commercial.
  • Ability to establish and maintain effective working relationships with the public.
  • Must be able to follow directions and to perform work according to department standards when no directions are given.
  • Must be emotionally mature and able to function effectively under stress.
  • Must possess crucial thinking skills, effective written and oral communication skills, strong self-initiative and interpersonal skills.
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Mon, 06 Feb 2017 00:00:00 EST 0
<![CDATA[Manager, Education Programs]]> The manager will be responsible for managing new preceptorship, reentry, retooling, and coaching programs, from the developmental and pilot testing stages to full implementation and evaluation. In this position you will be responsible for establishing accreditation systems for retooling programs, and programs for the structured assessment of surgical skills and surgical judgment.

This position will report to the Associate Director in the Division of Education.

Job Responsibilities:
  • Work with the Committee on Preceptorship to formulate standards; identify sites and participants; develop structures, processes, and systems; pilot test and evaluate results, and reformulate programs as needed.
  • Work with division leadership to develop innovative programs that assist surgeons with identifying retooling needs and that provide surgeons with attractive options for retooling. Manage efforts to develop guidelines and establish accreditation systems for retooling programs. 
  • Manage initiatives of the Committee on Coaching the Next Generation, such as the development, implementation, and evaluation of pilot programs and courses for senior surgeons who want to share their skills through formal teaching and coaching activities. 
  • Manage and facilitate the processes of developing objective structured assessments of surgical skills and surgical judgement for a variety of purposes and surgeon learners. Pilot test and evaluate the instruments; develop plans for dissemination and implementation as appropriate. 
  • Manage the implementation of the programs by establishing processes of recruitment and retention of institutions and sites, by training faculty, matching surgeons with programs, and by providing the infrastructure and systems to support and promote each program. Formulate program evaluation processes to monitor the participants' progress and satisfaction, and overall effectiveness of the programs.
  • Establish systems to effectively manage data and information generated from these programs in a confidential, secure, and legally appropriate manner. Explore ways to use the data to identify important trends and evaluate the programs. 
  • Other duties as assigned.


Qualifications/ Requirements:
  • Bachelor’ s degree in Education, English, health sciences or a related field required.   Master' s degree preferred.
  • Minimum of 4 years’ experience in a similar or related role required.
  • Courses education are required. Courses in curriculum development, project development and project management are preferred.
  • Superior communication skills are necessary to effectively interact with all levels of organization. 
  • Excellent writing and proofreading skills are required.
  • Meticulous attention to detail and organizational skills.
  • Strong working knowledge of Microsoft Office Products (Outlook, Word, Excel, Adobe Acrobat and PowerPoint). 
  • Self-motivated and able to work independently and as a member of a team.
  • Ability to plan and prioritize workload and meet deadlines.
  • Ability to establish strong working relationships with all division teams and management. 
  • Experience in Associations, professional services, healthcare, and/or education desired.  
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Thu, 02 Feb 2017 00:00:00 EST 0
<![CDATA[Clinical Nurse Specialist]]> Our Client is looking for a Clinical Nurse Specialist.

Job Responsibilities:
  • Serves as a resource for staff nurses and provides evidence based practices to support safe quality nursing practices.
  • Collaborates with multidisciplinary team members using the nursing process to integrate the nursing perspective into a comprehensive plan of care for the patient/family.
  • Identifies and prioritizes the nursing care needs for a select population and assists staff with the process.
  • Assists staff in developing critical thinking and clinical judgment skills.
  • Designs and evaluates innovative educational programs for nursing staff, patients and their families. 
  • Collaborates with others to resolve issues related to patient care, communication, policies and resources.
  • Mentors nurses to acquire new skills, develops their careers and effectively incorporates evidence into practice.  
  • Creates and revises nursing policies, protocols and procedures using evidence-based information to achieve the desired outcomes.       
  • Serves as a role model, demonstrating a professional demeanor in all interactions.
  • Demonstrates flexibility and adaptability dealing with multiple tasks and priorities.    
  • Advances the nursing practice by providing clinical expertise to assist nurses to improve patient care outcomes.
  • Creates an environment through mentoring as a change agent to empower nurses to practice at their highest level of engagement.
  • Acts as a Shared Governance Facilitator as needed.  
  • Provides formal and informal education for nurses and other health professionals.
  • Consults with nursing units and health care professionals to improve patient care.
  • Conforms to the established Standards of Behavior


Qualifications/ Requirements:
  • Current license as a Registered Nurse in the state of Illinois
  • A Master’ s degree (MSN) from a college or university required.
  • Current licensure as an APN.
  • Three (3) to five (5) years of experience in a clinical acute care setting.
  • ? Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
  • Demonstrates above average verbal and written communication skills.
  • Current CPR/BLS certification required. 
  • ACLS (Advanced Cardiac Life Support) certification at time of hire.
  • Proficient in Microsoft office skills.
  • The ability to be flexible with their schedule.
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Mon, 31 Oct 2016 00:00:00 EDT 0
<![CDATA[Network Systems Administrator]]> NETWORK ADMINISTRATORS STEP FORWARD!   Work for a top healthcare organization and partner with a director transforming systems to serve people.   We want the independent self starter savvy with Cisco Routers, Switches, Voice Applications and Security.  

You will under general direction design, support, maintain, and evaluate computers, networking and telecommunication systems. The systems administrator installs, configures, and maintains both physical and virtual computer servers; maintains network functionality and performance, email and performs other related duties as assigned.

QUALIFICATIONS INCLUDE:
Intermediate level of expertise in the following areas:  
  • Cisco routers, switches, VOIP, WCS, and wireless devices
  • Active Directory administration
  • Network Security administration
  • Exchange administration
  • Secure VPN administration
  • Citrix Technologies
  • System Back Ups and Disaster Recovery
  • Desktop support and PC imaging
  • Certifications and/or 4+ years of progressive experience, demonstrating expertise in Active Directory and network trouble shooting required
  • Ability to recognize problems, assesses criticality, and develops solutions.
  • High Level Desktop Support skills working in a help desk environment.
  • Excellent interpersonal and communication skills.
  • Ability to work well in team environment.
  • Excellent customer service skills.
  • Project Management and documentation skills.
  • A reputation for being a well rounded and innovative IT Professional.

 
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Mon, 31 Oct 2016 00:00:00 EDT 0