<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![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.
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Fri, 23 Jun 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, 23 Jun 2017 00:00:00 EDT 0
<![CDATA[Senior Clinical Study Manager, Clinical Operations]]> Our client seeks an exceptional candidate for a Senior Clinical Study Manager - Clinical Operations. This position reports into the Director or Senior Director of Clinical Operations. The right candidate will possess an understanding of Clinical Operations for successful execution of multiple clinical trials primarily in oncology and hematology indications in various phases of development.

Responsibilities of this position involve the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team. 

Job  Responsibilities:
  • Independent management of the operational aspects of clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
  • Identification and qualification of clinical trial sites and investigators alongside CRO including management of key relationships.  
  • Participation in final decisions for site selection
  • Participation in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs
  • Management of clinical study budgets and execution timelines.
  • Facilitation of investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
  • Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
  • Attendance at site visits to ensure oversight of CRO monitors and effective collaboration with Investigators and site staff.
  • Review study reports and metrics to ensure timely collection of clinical data, samples, and lab results.
  • Collaboration on SOP development and promotion of standardized clinical business tools.
  • Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
  • Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
  • Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).


Qualifications/ Requirements:
  • Minimum Education Required: Bachelor’ s degree in a scientific discipline required. Advanced scientific degree is preferred.
  • The candidate should ideally have minimum 5+ years in clinical trial management on the sponsor side
  • Experience in oncology trials would be helpful.
  • Experience in CRO, vendor and laboratory oversight is required.
  • Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
  • Creative problem solver with excellent communication and public speaking skills.
  • Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
  • Ability to travel for up to 30% of time, both domestic and international, may be needed.
  • Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global
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Fri, 23 Jun 2017 00:00:00 EDT 0
<![CDATA[Director, Quality Assurance]]> With an in-depth knowledge of the Quality System Regulations and FDA requirements, provides leadership for the Quality Assurance department and the company. Develops the quality strategy and ensures that the strategy integrates with other types of risks. Leadership role that requires sound judgment and the ability to assess the likelihood and impact of Quality 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 and Validation.

Job Responsibilities:
  • Develop and implement the Quality Compliance Strategy with both senior leadership and business functions within the company. Translate the strategy and vision into goals, objectives and measures for the organization.
  • Assure adherence of QA requirements of the company Quality System Manual. Maintain procedures and policies; ensure that QA maintains compliance with changes to the company Quality System Manual.
  • Partner with 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 QA organization 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 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 thought leadership to QA 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.

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 hold responsibility for performance management, for recruitment/ retention of personnel, and for expense 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 an 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.


Qualifications/ Requirements:
  • Bachelor' s degree in a Science discipline or a related field preferred or relevant systems experience. A Master’ s degree is highly desirable but not required.
  • Must have 10+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 CFR (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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Thu, 22 Jun 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
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Wed, 21 Jun 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
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Wed, 21 Jun 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.
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Wed, 21 Jun 2017 00:00:00 EDT 0
<![CDATA[Sr. Manager, Regulatory Affairs]]> My client is seeking a Senior Manager, Regulatory Affairs to serve as the global regulatory lead for assigned programs. This role requires expert interpretation of requirements relating to the development and licensing of biopharmaceuticals and communication to cross-functional teams to create innovative regulatory strategies for targeted biologics to treat cancer. Furthermore, the RA Senior Manager will represent the R&D team before health authorities. 

Job Responsibilities:
  • Responsible for developing innovative global regulatory strategies for assigned programs and working with the regulatory team on execution.
  • Represents regulatory affairs on cross-functional project teams to provide regulatory guidance and education through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements.
  • Responsible for maintaining and updating the regulatory strategy document and target product profile for assigned programs.
  • Interacts directly with health authorities and responsible for the compilation, submission, and maintenance of all clinical trial applications and marketing authorizations.
  • Adept at integrating biomarker/companion diagnostic strategies into the development of assigned programs.
  • Educates company on regulatory requirements and evolving trends and disseminates regulatory intelligence relevant to the business.
  • Provides regulatory due diligence assessments of new business opportunities.
  • Contributes to the hiring and development of team members to become leaders.


Qualifications/ Requirements:
  • Bachelor’ s degree in a scientific or health-related field (advanced degree highly preferred)
  • Minimum of 7 years of regulatory affairs experience in the biopharmaceutical industry
  • Experience in providing strategic advice on integrated regulatory development plans and executing the regulatory strategy for assigned programs
  • Experience with development of biomarkers and IVD companion diagnostics devices preferred
  • In-depth working knowledge of regulations, guidance, policies, and procedures pertinent to drug and biologics development and operational knowledge of IND/CTA and NDA/BLA/MAA submissions
  • Strategic thinker with excellent problem solving and influencing skills
  • Exceptional communication and presentation skills to ensure the regulatory strategy is clearly articulated in cross-functional teams
  • Exceptional writing skills with experience in drafting and submitting timely drug and biologic applications to health authorities
  • Track record of building an excellent relationship with the FDA and other regulatory agencies
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Wed, 21 Jun 2017 00:00:00 EDT 0
<![CDATA[Principal Medical Writer - Remote]]> Growing global sponsor is seeking Remote Medical Writers who are responsible for providing clinical regulatory document support to their clinical teams, ensuring high quality submission-ready documents.

Job Responsibilities:
  • Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).
  • Coordinates the review and approval involved in the production of clinical regulatory projects.
  • Understands, assimilates, and productively interprets sources of information, Ensures required documentation is obtained, including internal and external studies, research documentation, charts, graphs, and tables.
  • Arranges and conducts review meetings with the team.
  • Independently resolves document content issues and questions arising during the writing process.
  • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents.
  • Recommends, leads, and implements tactical process improvements.

  
Qualifications/Requirements:

  • Bachelor of Science required, with significant relevant writing experience, or Bachelor' s degree in English or communications, with significant relevant science experience.
  • High-level content writing experience and experience with all types of clinical regulatory documents required.

Preferred:
  • Masters or PhD in science discipline preferred with relevant writing experience.
  • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
  • Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
  • Knowledge and expertise with Common Technical Document content templates.
  • Expert knowledge of current electronic document management systems and information technology.
  • Excellent written and oral communication skills. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.
  • Working knowledge of statistical concepts and techniques.
  • Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
  • Expert in word processing, flow diagrams, and spreadsheets.
  • Excellent working knowledge of software programs in Windows environment.
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Wed, 21 Jun 2017 00:00:00 EDT 0
<![CDATA[Account Representative]]> Our client  is a private, non-profit healthcare organization and a  leader in developing standards to advance and promote patient safety in  health care through peer-based accreditation processes, education, and research. This organization currently accredits more than 6, 000 organizations in a wide variety of health care settings and is also the official accrediting organization for the US Air Force, US Coast Guard and Bureau of Federal Prisons. 


They are currently seeking an Account Representative for their Skokie, IL office. This position is primarily focused on ensuring the accurate and timely processing of accreditation surveys.   The Account Representatives provides customer service to applicant organizations to ensure the accurate, complete, and timely processing of application information.  The incumbent will also compile, interpret, and evaluate the data gathered during a survey then document and report those findings.  The Account Representative will report to and receive support from the Team Lead.

Job Responsibilities:
  • Develop and maintain customer relationships with a dedicated set of new and existing accounts under supervision and guidance
  • Review applications and work with customers to ensure all documents are accurate and complete
  • Develop a beginners level of knowledge and interpretation of standards and policies as outlined in the applicable   handbook
  • Evaluate reports to ensure accuracy and compliance with accreditation policies
  • Maintain continued contact with customers regarding ownership changes and prompting re-application prior to expiration


Job Qualifications:
  • Bachelor’ s degree or equivalent job-related experience in business and/or health care related courses preferred
  • Minimum 1 year customer service experience with the ability to communicate and develop a rapport
  • Intermediate computer skills and aptitude to learn new technology
  • Demonstrated ability to professionally communicate information to supervisors, co-workers, and external contacts via telephone, in written form, e-mail, or in person
  • 1-2 years health care experience
  • Energetic individual with multi-tasking abilities and attention to details
  • Flexibility, with a demonstrated ability to respond rapidly in an appropriate and controlled manner.

 
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Wed, 21 Jun 2017 00:00:00 EDT 0
<![CDATA[Sr. Project Manager]]> The Sr. Project Manager will coordinate the multiple cross-functional workstreams that will contribute to a successful EU launch. This will require working closely with cross-functional internal and external groups to oversee the definition, planning and execution of projects, while coordinating all related components. This includes, but is not limited to:- clarifying objectives, determining resources and delegating deliverables, prioritizing tasks to meet diverse interests, resolving scheduling conflicts, and managing change. Communicating proactively with key stakeholders, the Sr. Project Manager is responsible for aligning project life cycles with business goals and budgets, effectively managing project teams, and ensuring successful and timely delivery on project objectives. 

Job Responsibilities:
  • Overseeing project teams, providing direction, delegating tasks on a regular basis, and driving teams to attain assigned goals and milestones.
  • Offline alignment around deliverables and priorities with key cross functional partners
  • Coordinating cross-functional discussions and follow-throughs to ensure effective execution on project plans.
  • Communicating changes to key functional groups regularly, analyzing the effects of these on various stages of the project plan and on overall project scope. 
  • Working closely with key functional groups, developing project plans, identifying necessary project resources, and defining project timelines.
  • Defining and documenting project scope and objectives with a working knowledge of regulatory, commercial, medical affairs, market access, manufacturing processes / requirements, interdependencies with quality, compliance, facilities and IT groups, and any other necessary related functions.  Continuously assess project performance against these and re-direct efforts as necessary.
  • Successfully meet project plan deliverables, meeting / exceeding budgetary expectations.
  • Review, track and maintain the status of projects and deliverables through systems.  On an ongoing basis, provide status updates, progress reports, and ongoing cost analysis to senior management, identifying key bottlenecks and recommendations for resolutions in a timely manner.
  • As a key member of the EU Launch Readiness team, contribute to establishing the strategy for the project management team and make recommendations for future initiatives and enhancements as appropriate.
  • Create and present presentations as assigned.
  • Complete other related tasks as assigned.


Qualifications/ Requirements:
  • Education: Bachelor' s degree in life science, business, or other relevant disciplines required; Masters preferred.
  • Proven project management experience in a cross functional setting
  • 8+ years relevant experience in the biotech / pharmaceutical industry
  • Product Launch experience, ideally with a good understanding of the European biotech / pharmaceutical environment
  • 5+ years of relevant project management experience
  • Familiarity with various related project management systems / programs
  • In-depth working knowledge of the inter dependencies between the various cross-functional activities required to ensure a successful product launch in multiple countries across Europe

Skills:
  • Proficient working experience with Microsoft office applications, inclusive of MS Project
  • Strong verbal and written communication and organizational skills
  • Solid and proven track record managing multiple, complex projects and portfolios to completion 
  • Able to work in a fast paced environment with conflicting deadlines
  • Ability to work in a collaborative team environment
  • Excellent leadership, relationship building and interpersonal skills
  • Conflict resolution, Budget management / Time Management
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Wed, 21 Jun 2017 00:00:00 EDT 0
<![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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Tue, 20 Jun 2017 00:00:00 EDT 0
<![CDATA[Senior HR Business Parnter]]> Our client in the Northern Suburbs is looking for a Senior  HR Strategic  Business Partner

The Senior HR Strategic Business Partner is focused on driving business success by providing HR leadership, partnership and support to certain business units.  This is done by partnering to ensure HR strategy is aligned with business to achieve goals while maximizing human capital. 

Job Responsibilities:
  • Engaging with the Business - Understands needs of the business unit(s) and processes and the link between HR strategy and business strategy for those areas supported
  • Catalyst for Change - Applies change management and organizational development strategies, influences and assists organizational change initiatives in support of business strategies for specific business unit(s).
  • Culture Catalyst - Aligns actions to proactively support culture. Champions efforts in serving our people, clients, business and communities. As a trusted advisor and authentically humble, stays true to values regardless of internal/external pressures. 
  • HR Delivery Excellence - Ensures that HR services are provided as appropriate to internal client needs, identifies new opportunities where HR can add value, and maintains leading-edge knowledge of HR issues.  Knows the goals and also the big picture view.  Thinks divergently, as well as, critically and align.
  • Championing Employee Needs - Understands employee opinions, monitors the effect of business decisions on people, and advises management on addressing employees’ concerns
  • Performance - Effectively applies performance management to create a high-performance culture
  • Reward - Understands, communicates, and applies reward strategy
  • HR Analytics - Ability to develop and use metrics to make the business case for HR programs, to align HR strategy with goals, and to assess and justify the performance of HR/business programs.  Also, use data to predict talent gaps in advance and provide insights into how talent relates to business goals.
  • Employee Relations - Applies employee relations and employment practices in order to create a positive, ethical, effective work environment.  Grows relationships while maintaining confidentiality.
  • Relationship Building - Build effective relationships within HR and external to HR with business leaders and employees.
  • Transactional Knowledge - Ability to use knowledge about legal and HR processes to solve problems


Qualifications/ Requirements:
  • BA/BS in Human Resources, Business, or related concentration
  • PHR/SPHR certification preferred
  • 8+ years of experience in a human resources and talent management environment, with proven ability to produce positive results.
  • Preferred Healthcare, Medical or Corporate experience, but we will consider other industries as well.
  • Strategically partners with senior leadership to manage complex business initiatives and effectively meet the needs of businesses.
  • Solid knowledge of all MS Office Products
  • Travel:  10%
]]>
Tue, 20 Jun 2017 00:00:00 EDT 0
<![CDATA[Associate Director, Program and Alliance Management]]> Associate Director, Program and Alliance Management

My client is seeking an experienced and energetic Program Manager/Program Leader.  The ideal candidate will play a key role in supporting multiple programs in a program management role.  This is a key role in building the client’ s Program and Project Management capabilities, ensuring that development program goals are met and that resources are appropriate deployed.

The candidate will lead cross functional teams working on complex projects, including CMC, nonclinical, clinical, regulatory, commercial functions. The candidate will play a key role in day-to-day operations and planning, and will represent the Program to internal and external constituencies, including development partners. In addition, the candidate will be asked to evaluate current team structures and process and recommend potential improvements.

Requirements:
  • B.S., M.S. or Ph.D. in scientific or medical discipline (ie. biology, chemistry, medical technology).
  • PMP Certification or equivalent preferred.
  • Minimum of five years of progressive project management experience.
  • Strong project management skills and ability to work cross functionally
  • Have experience with the following:
  • Involvement with the full product development cycle, include commercialization
  • Development of integrated program and project plans
  • Ability to create and update detailed budget and resource tracking tools.
  • Able to aptly navigate and create documents in MS Project, Excel, and PowerPoint
  • Strong understanding of CMC activities required for successful manufacturing and scale up of biologic products.
  • Solid understanding of FDA and ICH guidelines.  Additional knowledge of global regulations is highly desired.
  • Exceptional interpersonal skills that will span the spectrum from internal colleagues to external partners, Board Members, vendors, key opinion and thought leaders.
  • Experience working within and/or managing a collaboration

 
]]>
Fri, 16 Jun 2017 00:00:00 EDT 0
<![CDATA[Study Project Manager - Oncology - Remote]]> Manages clinical trials and provides therapeutically aligned, scientific strategy and operations management for the planning, execution and reporting of clinical development programs to enable successful global registration and commercialization of drug development projects.   Areas within Clinical Operations include clinical program and study management, monitoring, document management, medical writing, safety management, clinical planning and resource management, systems support, “ Standard Operating Procedure” training and compliance, and continuous improvement program management.

Job Responsibilities:
  • Project manager responsible for the overall execution of clinical trial(s) from study concept through study completion.
  • May have direct reports and matrix management of assigned study team(s) to ensure compliance and execution on timelines and deliverables.
  • Aware of both internal and external business environments, assess impact on clinical studies and make modifications as necessary.
  • Escalate performance issues to management with plans for resolution and ensure coordination/sharing of information within the therapeutic area.
  • Responsible for compliance with applicable Corporate and Divisional policies and procedures.
  • Manage the implementation, on-time execution and conduct of clinical studies including the development of the Study Plan, key milestones, timelines, study costs, vendor selection and resource needs as well as ensuring quality and compliance.
  • Provide input on regulatory documents (e.g., Investigator’ s Brochure (IB), CSR, and the IND/DSUR).
  • Effectively communicate study progress and actively identify issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues.


Qualifications/ Requirements:
  • Bachelor’ s degree or equivalent is required, typically in nursing or scientific field.   An Associate’ s degree/R.N. or equivalent with relevant experience is acceptable.
  • Must have 6+ years of pharmaceutical related / clinical research related experience.
  • Must have demonstrated a high level of core and technical competencies through management of clinical trials.
  • Possess good communication skills and demonstrated leadership abilities.
  • Demonstration of successful coaching/ mentoring in a matrix environment.
  • Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
  • Preferred exposure in study initiation through study completion in multiple phases of studies (Phase 1-3, 4).
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Learns, fast, grasps the ' essence' and can change the course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.
]]>
Fri, 16 Jun 2017 00:00:00 EDT 0
<![CDATA[A/p Clerk]]> The Accounts Payable Clerk is responsible for general accounts payable functions including invoice entry, scanning of invoices, and appropriate communication via phone and email.

Job Responsibilities:
  • Enter invoices into accounting software Lawson
  • Review invoices for accuracy and completeness
  • Acquire necessary approvals to authorize for payment
  • Communicate with vendors and research vendor statements
  • File and organize vendor invoices and other documents
  • Setup name & address record for new vendors and administer W-9 documentation


Qualifications/ Requirements:
  • High School diploma required
  • Minimum 1-2 years in an accounting / office environment
  • Attention to detail
  • Must work effectively in a team environment
  • Excellent written and verbal communication skills
]]>
Thu, 15 Jun 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
]]>
Tue, 13 Jun 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, 13 Jun 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
]]>
Tue, 13 Jun 2017 00:00:00 EDT 0
<![CDATA[Clinical Trial Assistant]]> The Clinical Trial Assistant (CTA) will support the clinical project teams in the following areas: project timelines, maintaining trial master files, tracking clinical supplies (other than test article). The CTA may act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation. This role functions as in-house support.

Job Responsibilities:
  • Follow all appropriate Standard Operating Procedures (SOPs).
  • Assist with the creation and maintenance of documentation for given clinical studies.
  • Establish and maintain the Trial Master File (TMF). Under the supervision of the CPM or designee, review the TMF for compliance for given clinical studies.
  • Assist with maintenance of the tracking tools of clinical studies and produces reports as needed.
  • Responsible for accurate distribution of all clinical trial related materials) other than test article) to clinical trial sites or team members.
  • Maintain communication files for clinical trials as needed.
  • Assist in the creation of study materials, presentations, agendas, and other materials.


Qualifications/ Requirements:
  • Bachelor’ s degree in a scientific or healthcare discipline is preferred.
  • Excellent written and verbal communications skills including superior command of English.
  • Proficient computer skills with experience in Microsoft Word, Excel, and PowerPoint.
]]>
Mon, 12 Jun 2017 00:00:00 EDT 0
<![CDATA[Technical Writer]]> The primary responsibility of the person hired will be to support R&D Innovation through  tech-edit all components of the company' s training and certification product suite. Other responsibilities include fulfilling other tech-editing needs as capacity allows for the company' s product suite.This is a 6 month contract role with potential for extension. 

Job Responsibilities:
  • Training and Certification Technical Editing of various types of files
  • Tech editing for as needed
  • Incorporation existing and creation of additional design images for  training and marketing purposes


Qualifications/Requirements:
  • BS degree in English, Business Writing, or relevant from an accredited institution
  • 5 years of relevant experience in technical writing
  • Previous history and work experience in content management editing
  • Previous experience and work history with image and infographics creation
  • Graphic design exposure/background
  • Global work history
  • Professional Association/volunteer engagement
  • Non-profit
  • Multi lingual
  • Cultural sensitivity
  • Multilingual
  • Ability to work independently
  • Excellent oral, and written communication and presentation skills (ability to present new ideas, approaches, and information clearly)
  • Results Oriented, focused, highly motivated, self-starter
  • Attention to detail
  • Ability to effectively multi-task, manage multiple projects simultaneously, and meet deadlines
  • Diligent work ethic and insatiable desire to learn and develop skills
  • Ability acquire new knowledge quickly
  • Strong interpersonal skills
  • Time management, organizational skills
  • Cultural sensitivity/awareness
  • Team player, ability to build strong relations internally across functional areas and externally with vendors, suppliers, members, constituents, and volunteers
  • Commitment to company purpose and values
  • Proficiency in Microsoft Office products (Word, PowerPoint, and Excel)
  • Collaborative
  • Strong business acumen
  • Creativity and entrepreneurial skills
]]>
Fri, 09 Jun 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
]]>
Thu, 08 Jun 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.
]]>
Wed, 07 Jun 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.
]]>
Mon, 05 Jun 2017 00:00:00 EDT 0
<![CDATA[HRIS Analyst III]]> Job Responsibilities:
  • Assume daily HRIS tasks while team is engaged in year-long implementation project.
  • Will handle any configuration changes in Taleo that are compliance related to the recruiting or onboarding process.
  • Handle day to day Peoplesoft queries
  • Will cross train with team for first few weeks and then must have the ability to work  independently. 
  • Analyze, maintain and troubleshoot human resource information systems and other human resources computer applications and systems.
  • Train employees on system usage. Lead projects which impacts data maintenance on the HRIS, including mass updates.
  • Plan and develop analyses, reports, and presentations.
  • May act as administrator to create security model based on functional responsibilities and configure HR system to enforce the security access to data.


Qualifications/ Requirements:
  • Typical years experience in field of 5+ years. Typically holds Bachelor' s Degree. 
  • Must have BOTH Taleo and Peoplesoft Experience
  • Must have configuration experience and strong  best practices experience.
]]>
Thu, 01 Jun 2017 00:00:00 EDT 0
<![CDATA[Senior Manager, Medical Writing - Neuroscience]]> The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Neuroscience Programs. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management, with support from management as needed. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.

Job Responsibilities:
  • Independently preparing PCS, protocols, and protocol amendments often acting as the compound lead
  • Independently preparing all sections of the CSRs, including narratives, working across functional areas to obtain all applicable source material
  • Routinely engaging clinical research and biostatistics to gain comprehensive understanding of study design, objectives and results
  • Providing guidance to other medical writers applying industry and medical writing best practices
  • With minimal supervision, preparing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports
  • Contributing to the writing of marketing application submission documents
  • Managing processes for obtaining feedback for improvements for the document standards and structure
  • Providing mgmt. with appropriate information to ensure procurement of adequate and timely resources to complete medical writing deliverables
  • At the Director' s discretion, may provide work direction to contractors/consultants
  • Contributing to process improvement within and across functional areas
  • Influencing medical writing strategies and processes within and across functional areas
  • Working with teams to develop project specific metrics compliant with standard project metrics
  • Monitoring and evaluating project metrics, escalating issues as needed


Qualifications/ Requirements:
  • Bachelor' s Degree required; an advanced degree is preferred.
  • Minimum of 5 years' medical writing experience in CNS, with specific experience with compounds targeted for epilepsy preferred
  • Must have participated in a major marketing application submission
  • Strong critical thinking and problem solving skills
  • Self-motivated with the ability to influence others
  • Ability to multitask
  • Result driven with the ability to demonstrate time management and project planning
  • Able to work on site
  • Advanced working knowledge of MS project and MS Word
  • Experienced in the use of a document management system
]]>
Wed, 31 May 2017 00:00:00 EDT 0
<![CDATA[Associate Director - Medical Writing - Neuroscience]]> The Associate Director - Medical Writing will be the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for providing needed support and direction to other staff/contractors on these programs. As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. 

Job Responsibilities:
  • Working on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Independently prepares and at times may direct, the writing of PCSs, protocols and protocol amendments
  • Independently prepares and at times may direct, all the writing of the CSRs including narratives
  • Works across functional areas to obtain all applicable source materials
  • Leads the preparation of clinical sections of submission documents, such as the briefing books, Global Investigator Brochures, and annual regulatory reports
  • Leads the medical writing activities for marketing application submission documents
  • Liaises with other functional areas and groups in the development of document standards and structure
  • Interacts routinely with clinical research and biostatistics staff to gain comprehensive understanding of the study design, and results across the program


Qualifications/ Requirements: 
  • BS required/MS preferred
  • Minimum of 8 years medical writing experience in an industry setting, with specific experience with compounds in Neuroscience
  • Must have participated in or lead a major marketing application submission
  • Strong critical thinking and problem solving skills
  • Self-motivated with the ability to influence others
  • Ability to multitask on complex projects
  • Result driven with a mastery of time management and project planning
  • Able to work on site
  • Advanced working knowledge of MS project and MS Word
  • Experienced in the use of a documentum system
]]>
Wed, 31 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.
]]>
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.
]]>
Tue, 23 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
]]>
Mon, 22 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.
]]>
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
]]>
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.
]]>
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)
]]>
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
]]>
Tue, 16 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.
]]>
Mon, 08 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[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
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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
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Tue, 25 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[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.
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Tue, 11 Apr 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.
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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[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[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