<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![CDATA[Assistant Director, Safety Management]]> Job Description:

This position will manage, lead and develop staff across therapeutic area team(s) within Safety Management, and to function as a resource within Safety Management, Clinical Teams, and the larger organization by effectively identifying staff and department needs that can help translate business vision into broad and actionable strategy.

Job Responsibilities:
  • Identify, initiate and implement process and workflow procedure improvements by monitoring and communicating workload projections and metrics for respective therapeutic areas and by participating in area budget process and proposals for assigned teams of healthcare professionals (approx. 5 to 40).
  • Function as a resource within Safety Management, Clinical Teams, and the larger organization with insight into industry trends and processes, and audit activities.
  • May assist in development of department training programs, ongoing knowledge attainment, and development of staff, by effectively identifying department and staff needs and successfully presenting them to management.
  • Assist management with strategic planning and development within Safety Management by facilitating incorporation of appropriate activities into therapeutic area teams activities and projects and demonstrating excellent interpersonal leadership, communication and development skills.
  • Ensures application of clinical SOPs reflecting evolving global regulations and processes related to clinical trials are implemented within assigned teams; and clinical SOPs are being followed within assigned teams.
  • Assists in the implementation of standardized clinical safety training and performance assessments by providing change leadership for technology and process improvements.
  • Routinely interact with Divisional Vice President for therapeutic area(s), Product Safety Team, and AD/Directors in multiple cross-functional areas (Regulatory Affairs, Pharmacovigilance, Data Management, Clinical Field Operations, Clinical Program Management, Document Management).
  • Oversight of the timely capture of accurate quality, clinical adverse event information; and responsibility for resourcing model/plan for assigned therapeutic area(s) teams.
  • Directly responsible for the design and execution of safety management activities including successful completion of CSR deliverables (e.g. narratives), TMF deliverables, etc. Operates independently, with recognition of risk.
  • The potential actions of this position could impact the accuracy of decision-making regarding assigned products in clinical studies with respect to product approval and safety labeling (both marketed/un-marketed), patient safety and patient quality of life. Consequences of non-compliance could result in audits, warnings, penalties and sanctions that could impact both public safety and financial business goals.

Job Requirements:
  • Bachelor' s degree is required in nursing or scientific field. Advanced degree is desirable.
  • 8+ years of clinical development or directly related experience and 4 or more years of direct management experience.
  • Must have demonstrated extensive knowledge in clinical safety reporting with cross discipline exposure and knowledge.
  • Must have proven organizational, project management and leadership skills with the ability to lead the Safety Management organization within a global matrix environment.
  • Must be able to understand the global environment from operations as well as regulatory/GCP perspective.
  • Must have experience building effective working relationships across functions.
  • Must have prior experience in resource planning.
  • Must have demonstrated strong leadership competencies as a Clinical Safety Manager or equivalent with broad business orientation with leadership in standard business procedures (SOP, Global Regulations, OEC, Outsourcing, PV) and the application of those procedures to the business.
  • Must be a subject matter expert, as a leader of initiatives and a key contributor to the advancement of Safety Management as an organization.
  • Expert on Industry Best Practices in Clinical trial Safety that drive process improvement initiatives and implementations within assigned therapeutic areas.

 
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Tue, 15 Aug 2017 00:00:00 EDT 0
<![CDATA[Associate Director, Regulatory Affairs Project Management]]> The Associate Director, Regulatory Affairs Project Management has overall responsibility for managing submission projects involving multiple cross-functional teams. Working with Regulatory Affairs and Regulatory Operations, the Submission Manager establishes and maintains submission plans and associated timelines and runs tactical submission team meetings. The Individual is recognized as a discipline expert and resource.

Job  Responsibilities:
  • Manage operational oversight to ensure timely, high quality regulatory submissions.
  • Work with program teams to formulate submission plans, including timelines and deliverables.
  • Manage multiple projects and competing priorities.
  • Plan and conduct submission team meetings.
  • Act as interface with project teams to ensure that timelines and document requirements are mutually understood and in line with health authority standards.
  • Communicate effectively verbally and in writing, across various levels within the organization.
  • Contribute to the development of submission processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions.
  • Identify opportunities for efficiencies and process improvements.
  • Demonstrate team leadership skills and ability to influence. Build and maintain positive relationships internally and externally.
  • Train and mentor junior staff


Qualifications/  Requirements:
  • Bachelor’ s degree
  • Minimum of 5 years of regulatory experience in pharmaceutical industry
  • Experience preparing regulatory submissions in eCTD format (including NDAs/BLAs, sNDAs, INDs, CTAs, DSURs, annual reports, meeting packages) and managing projects
  • Ability to coordinate regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication.
  • Must have a solid understanding of FDA regulations and ICH guidance’ s.
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks.
  • Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
  • Strong communication skills both oral and written
  • Proven leadership skills and presence
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Tue, 15 Aug 2017 00:00:00 EDT 0
<![CDATA[Associate Director, Labeling - Regulatory Affairs]]> Associate Director of Regulatory Affairs Labeling is responsible for providing  regulatory guidance and oversight of US and global labeling activities for assigned products.  This person will report to the Head of Regulatory Affairs and will be responsible for maintaining labeling documents throughout the product lifecycle.   The person assuming this newly created position will have a unique opportunity to build, develop, and update labeling processes, systems and SOPs.

Job Responsibilities:
  • Provide expertise in labeling requirements while staying current in regulations and guidance’ s
  • Manage and improve labeling development process and SOPs for company products
  • Work cross functionally to establish and maintain a core company data sheet for approved products
  • Manage required labeling updates, proofreading, and version control 
  • Manage quality control over entire labeling process
  • Work with the Regulatory Affairs Strategist on planning, managing and implementing labeling updates
  • Work with Regulatory Affairs strategist to research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.
  • Review Regulatory Target Product Profiles as requested
  • Work with Supply Chain and Regulatory Operations to facilitate conversion of label to structured product labeling (SPL) and updating SPL as needed for CMC and labeling changes
  • Communicate and disseminate newly approved labeling to internal stakeholders
  • Work with corporate partners to obtain current versions of labels for partner-owned products; communicate and manage labeling changes with global partners, as appropriate.
  • Maintain tools that support coordination with other functions (e.g., Marketing) to ensure only agency approved labels are produced for appropriate products
  • Maintain and catalog all labeling materials in accordance with company policies, procedures, and technologies. 


Qualifications/ Requirements:
  • BS degree in life sciences required, Graduate degree in Regulatory or related discipline preferred
  • 9 years of experience in regulatory affairs with focus on labeling for at least 5 years
  • Experience associated with US product labeling regulations required
  • Experience with SPL and PLR format required
  • Thorough understanding of US labeling regulations is required
  • Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
  • Must have a good understanding of the pharmaceutical environment and the ability to work proactively through labeling revisions and the product review process
  • Must have the technical ability to become quickly proficient in the use of controlled regulatory document management systems
  • Global regulatory/ labeling experience - familiarity with labeling regulations in other countries (e.g., EU, Canada, Australia,  Japan) is desired
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Tue, 15 Aug 2017 00:00:00 EDT 0
<![CDATA[Senior Consultant, GMP Quality Assurance]]> Senior Consultant, GMP Quality Assurance

My client is a growing oncology pharmaceutical company looking to add a strategic consultant to their team.

The Quality Assurance consultant will be available for ad hoc/1 day a week (remote) quality support and compliance oversight for controlled documentation including SOP’ s, batch records, material specifications, product specifications and study protocols and reports.   The incumbent will assist the VP of Technical Operations in questions on leading quality and compliance activities of early to late stage clinical trials.

8-10 hours per week, remote possible, 1-2x per month onsite as needed

Responsibilities
  • Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
  • Assist with the creation, review and modification of Standard Operating Procedures (SOPs)
  • Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
  • Assists with GMP and GCP audits and risk assessments.

Qualifications
  • BS in life sciences/health related discipline. Chemistry degree preferred/plus
  • Minimum 5 years of experience in biotech/pharmaceutical industry; 3 or more years of experience in quality assurance
  • Experience with working with and qualifying external vendors
  • Working knowledge in both GMP & GCP

 

 

 

 

 

 

 
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Tue, 15 Aug 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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Mon, 14 Aug 2017 00:00:00 EDT 0
<![CDATA[Senior Medical Writing Consultant]]> Our client is seeking a Medical Writing Consultant to 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.

Job Responsibilities:
  • 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.
  • Function as an integral part of the Medical Writing team which includes external vendors.
  • Ensure a consistent style of presentation of documents to maintain quality and ease of review.
  • Perform quality control (QC) review of clinical study reports and other submissions written by other medical writers.
  • Keep management informed on progress documents and other project related information.
  • Assist management in projecting resources, and perform administrative duties as requested.
  • 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:
  • 3+ years as a medical writer, or equivalent, and presenting relevant specialist qualifications;
  • Bachelor’ s degree in a clinical, scientific, or industry-related discipline is strongly encouraged.
  • Experience with NDAs
  • Onsite 2-3 days a week required, live within commutable distance
  • Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired.
  • Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
  • Familiarity with the requirements for preparation of key clinical and regulatory documents
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Mon, 14 Aug 2017 00:00:00 EDT 0
<![CDATA[Pharmacovigilance Operations Associate (Physician)]]> As a Pharmacovigilance Operations Associate (Physician), you will support the Pharmacovigilance team in reviewing, querying, documenting and reporting on all serious adverse events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR) cases related to clinical studies.

Job Responsibilities:
  • Provide timely and sound medical review of individual case safety reports (ICSR) from clinical trials.
  • Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available.
  • May participate in the case narrative generation, review and refinement process depending upon level of experience.
  • Conducts several rounds of query and response (back to site) to gain complete and accurate case information.
  • Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications.
  • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
  • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
  • High Comfort Level in working in Multidisciplinary teams; providing input in team meetings and relaying information to PV management.
  • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
  • Contribute to preparation and review of periodic reports (DSUR, CSR)
  • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
  • Participate in departmental development activities including Training Staff, SOP and Work Instructions development.
  • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
  • Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
  • Participate in Risk Management Strategy
  • Other activities, as needed or as requested by manager.


Qualifications/ Requirements:
  • Doctor of Medicine or Doctor of Osteopathic Medicine required; equivalent foreign medical graduates may be considered.
  • A minimum of 3 years Drug Safety/Pharmacovigilance experience in a pre-approval setting.
  • Oncology experience required.
  • Experience with Oracle’ s Argus Safety Suite or comparable database required.
  • Strong familiarity of GCP, ICH and Global regulations.
  • Experienced in the evaluation and interpretation of data
  • Ability to multi-task
  • Solid written and oral communication skills.
  • Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner.
  • Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
  • Close attention to detail.
  • Ability to collaborate well with others.
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Fri, 11 Aug 2017 00:00:00 EDT 0
<![CDATA[Quality Assurance Auditor]]> To conduct audits of new and existing suppliers and vendors in support the new and commercialized products, as well as internal audits. Responsible for scheduling, performing, and reporting the audit results as tracking follow up actions.

Job Responsibilities:
  • Prepares audit schedules (internal and external) and conducts QA/QC audits as directed, related to suppliers including contract manufacturers, active pharmaceutical ingredients, contract laboratories, as well as   internal audits.
  • Assist in monitoring, scheduling, conducting, and reporting of cGMP activities for suppliers and partners.
  • Communicate the results of the audits to the manufacturing site and applicable personnel.
  • Assures that the suppliers/vendors/contractors meet the internal and regulatory requirements.
  • Maintain audit and correspondence records to evaluate the process trends and potential non-compliance to the quality requirements.
  • Coordinate and perform compliance projects as required by the management. Projects may include product reviews, equipment and process qualifications, change control, etc.
  • Review and assess the audit responses against the current industry standards and guidelines to ensure that sufficient controls are in place and meet Quality standards and requirements. Follow up on the implementation of the corrective actions associated with the audit observations until completed.
  • Provides quality evaluations of suppliers and contractors to reduce the risk of data or site being unacceptable to quality standards and FDA requirements.
  • Ensures that the audit budgets are not exceeded by advance scheduling and ensuring that multiple audits are performed in the same geographical area in order to minimize expenses.
  • Serve as QA representative on multi- site multi-function project teams, as needed.
  • Support and participate in project management meetings as necessary, to ensure that the new product launches are carried out in accordance with quality standards.
  • Acts on Vice President of Quality Assurance’ s behalf, as designated.


Qualifications/ Requirements:
  • Bachelor Degree in sciences (i.e.: chemistry, microbiology)
  • At least 5 years of progressive challenging QA/QC experience in the pharmaceutical industry with at least 3 years of auditing experience.
  • In-depth knowledge of cGMP, cGLP, Aseptic Processing, as well as FDA trends regulations, and guidelines.
  • Capable to work independently and part of a team, able to coordinate multiple projects.
  • Must possess exceptional communication and organizational skills.
  • Ability to travel domestically and internationally (50-60 % of the time).
  • In depth knowledge of current GMP regulations as well as FDA trends and guidelines.
  • Possesses strong organizational skills for prioritizing workload and responsibilities.
  • Strong written communication, interpersonal, and problem solving skills are required.
  • Proficient with PC-based word processors, databases and spreadsheets.  Experience in working with Finished Product manufacturers.
  • Familiarity with CMC regulatory issues a strong plus.
  • CQA
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Fri, 11 Aug 2017 00:00:00 EDT 0
<![CDATA[HR Manager]]> Our client is a leader in transforming logistics and supply chain management into a critical business strategy based on collaborative partnerships, innovative thinking and high-performance operations. They achieve the business goals of Fortune 500 and other dynamic companies by designing, integrating, managing and adapting customized supply chain solutions. As a Lead Logistics Partner   and third-party logistics provider, they deliver value by reducing total system costs, optimizing business processes, facilitating growth and change, and maximizing the potential of the supply chain. In today’ s environment, filled with rapid and unpredictable change, they help customers achieve their goals

Our client is looking for a dependable and skilled  Human Resources Manager  at their Des Plaines facility. 

Job Responsibilities:
  • Operations Management  Lead the human resource effort to ensure all polices, processes and regulations are adhered to in a consistent and timely manner. Responsible for staffing, on-boarding and retaining top talent to execute and achieve business goals.
  • People Leadership:  Partners with senior HR leader and operational team to develop a culture of positive employee relations and engagement. Responsible for providing training, coaching, and counseling to develop a strong team and improve retention. Partners with senior HR on employee issues and/or complaints to ensure all concerns are investigated thoroughly, documented properly and resolved in a timely manner.
  • Information & System Management:  Maintain a thorough knowledge of the HR systems and operational systems as it relates to human resources. Responsible for utilizing the systems to accomplish the goals of the business ensuring accurate data is submitted in a timely manner. Maintain a high level of integrity and confidentiality when utilizing the data. Provide information to the appropriate stakeholders to support the success of the operation.


Qualifications/ Requirements:
  • 4 to 6 years in human resource management role
  • Bachelor’ s degree required
  • SHRM or HRCI certification preferred
  • Demonstrated leadership skills
  • Strong written and verbal communication skills

Internal/External Contacts:
  • Reports to Senior HR Manager
  • Vice President, Group General Manager and/or General Manager
  • Logistics Managers
  • Corporate HR Team
  • Payroll Team
  • Hourly Employees

 
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Fri, 11 Aug 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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Thu, 10 Aug 2017 00:00:00 EDT 0
<![CDATA[HR Generalist]]> The HR Generalist will be responsible for all day-to-day employee relations issues, contribute to the efforts in recruitment and retention, workforce development and training and compensation and benefits; which involves planning, developing, recommending, and implementing HR activities, policies, procedures, and programs.   This position works a 4 day on / 3 day off schedule and will require relocation to Juneau, AK.

Job Responsibilities:
  • Ensures proper and timely recruitment activities for company personnel including creation of job descriptions, requisitions and recruitment advertisements; partners with state employment agencies and professional recruiters as needed.
  • Communicates with site leaders and managers on HR initiatives as they relate to business priorities.
  • Works with Corporate HR Team to ensure consistency and best practice sharing to leverage with the Alaska site.
  • Assist with employee relations issues including performance evaluations, promotions, and administration of discipline and performance improvement plans; conducts exit interviews.
  • Attends meetings, conferences, job fairs, seminars, and similar events as required or directed.
  • Contributes to the creation and facilitation of training program(s).
  • Serves as company liaison and employee advocate with third-party benefits administrations.
  • Contribute new approaches, policies, and procedures to effect continual improvements in efficiency of department and services performed.
  • Ensures departmental compliance with all local, state, federal and company rules.
  • Demonstrates required behavioral skills including productive communication, cooperation, productivity, initiative, creativity, dependability


Qualifications/ Requirements:
  • Ability to work safe and promote safe behavior in others.
  • Bachelor’ s degree in HR Management or other related discipline.
  • Minimum  3-5 years exempt level of human resources generalist experience.
  • Knowledge of current employment law, and applicable state and federal laws and requirements, as well as human resources policies and procedures.
  • Sets high standards for self and others, builds trust and takes accountability.
  • Other duties as assigned.
  • Preference given to Alaskan applicants.
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Thu, 10 Aug 2017 00:00:00 EDT 0
<![CDATA[Sr. HR Manager]]> The Regional Human Resources Manager is responsible for providing support to multiple locations; directing and coordinating HR activities related to the consistent application and practice of company HR Policies, such as employment, compensation, benefits and related activities. 

Job Responsibilities:
  • Partners with senior management in the communication and administration HR Policies and Procedures.
  • Provides consultation and support to management on various employee related issues.
  • Partners with senior management of the communities to ensure a productive and effective work environment is in place
  • Coordinates employee forums to ensure the community provides an avenue for employees to communicate concerns, challenges and triumphs
  • Responds to employment issues and formulates recommendations for corrective action/improvement based upon case analysis, company policy and governmental mandates.
  • Oversight of community orientation programs.
  • Facilitation of Employee Survey Process.
  • Provides training & development on various HR related topics.
  • Ensures governmental compliance by coordinating & assembling data for required federal and state reporting.
  • Oversight & coordination of community Recruitment Programs.
  • Designs and provides human resources management tools.
  • Responsible for the oversight of maintaining employee information such as personal data, compensation, benefits, attendance, performance reviews or evaluations and termination date and reason.
  • Manages community health and welfare benefit programs.
  • Developing and deploying employee relations programs supportive of community goals and objectives.
  • Maintain confidentiality of all employee information in order to protect their rights.
  • This job description is not intended to be all-inclusive.  The employee will be expected to perform other reasonable duties as assigned by Management.
  • Meets regularly with Executive Director to communicate recommendations, open challenges and discuss overall employee satisfaction.


Qualifications/ Requirements:
  • Graduate of an accredited college or university required; concentration in Human Resources strongly preferred. 
  • Must possess, as a minimum, five (5) years of experience in the field of human resources with a minimum of two (2) years supporting multiple entities
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Thu, 10 Aug 2017 00:00:00 EDT 0
<![CDATA[Human Resources Generalist / Leave Program Specialist]]> Job Responsibilities:
  • Serves as the subject matter expert for the leave and workers’ compensation programs in alignment and under the general direction and guidance of HR leadership and the legal department. 
  • Interprets and administers leave programs and policies in accordance with the applicable federal and state employment laws (FMLA, ADA, USERRA, Pregnancy Discrimination Act, etc.). Ensures that the workers’ compensation program is managed in accordance with applicable OSHA and workers’ compensation laws.
  • Manages all administrative aspects of leave and workers’ compensation claims to include tracking hours used/taken and working closely with Payroll to ensure that pay for associates is accurate and correct. 
  • Administers all aspects of leave and workers’ compensation programs. Provides extensive case management and coordinates administrative aspects of the cases and claims. Conducts/coordinates investigations into all reported workers’ compensation claims.
  • Independently approves and/or denies leave cases based on relevant medical information. Coordinates and organizes all medical information and ensures that HIPAA and Employee Privacy guidelines are closely monitored and effectively executed. Ensures that all reportable workers’ compensation claims are submitted to the company’ s vendor within 48 business hours from the date of the incident.


Qualifications/ Requirements:
  • A bachelor’ s degree in human resources, business administrator, or related field required
  • Two (2) years’ experience in Human Resources required
  • Two (2) years’ experience in managing leave cases (FMLA and Worker’ s Compensation) required
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Thu, 10 Aug 2017 00:00:00 EDT 0
<![CDATA[HR Manager]]> The Human Resources Manager supports the Human Resources Department with the overall administration, coordination, and evaluation of the Human Resources functions and processes.  This includes management of the data in the Human Resources Information System (HRIS), records management, and collaborating closely with the Leadership Team, divisions, and employees in regards to all aspects of Human Resources.

The Human Resources Manager reports to the Chief Financial Officer.

Job Responsibilities:
  • Manage and administer all payroll activities including ensuring timely processing of payroll and all financial obligations related to the payroll process.  Develop yearly payroll schedules and maintain updated payroll documentation including processes.  Manage requests from employees, agencies, worker’ s compensation, benefits vendors, etc. 
  • Manage administrative tasks, including on-going maintenance of personnel records and employment verifications. 
  • Manage the HRIS including employment transactions, applicant tracking system, reports and processes, the employee portal, and self-service tools. 
  • Develops and administers various Human Resources plans and procedures for all company personnel.  This includes acting as a strategic business partner to the leaders, effectively communicating plans, processes, and administration to company. 
  • Manages and resolves complex employee relations issues. Conducts effective, thorough and objective investigations.  Interprets and communicates policies and best practices.
  • Administer employee benefits programs, including retirement plans, medical plans, life insurance plans, temporary disability programs, accidental death policies, employee assistance programs, worker’ s compensation, and unemployment claims.
  • Conducts training on various Human Resources requirements. 
  • Files EEO-1 annually as well as OSHA logs; maintains other records, reports and logs to conform to EEO regulations.  
  • Ensures compliance with all federal, state and local employment laws in multiple states.    
  • Evaluates reports, decisions, and results of department initiatives in relation to established goals. Recommends new approaches, policies and procedures to effect continual improvements in efficiency of department and services performed. 
  • Conducts recruitment effort for all exempt and nonexempt workers; writes and places advertisements; works with supervisors to screen and interview candidates; extends job offers; complete background check; conducts new-employee orientations; monitors career-path program and employee relations counseling; conducts exit interviews. 
  • Review and rewrite job descriptions as necessary.
  • Manages multiple HR project initiatives to support departmental and corporate goals.  
  • Develop and execute employee recognition programs. 
  • Develops, recommends and implements personnel policies and procedures; maintains handbook on policies and procedures; 
  • Maintain employee compliance with the federal and state regulations concerning employment.


Qualifications/ Requirements:
  • Bachelor’ s Degree in Human Resources or Business Administration, or equivalent work experience preferred
  • Five (5) or more years of Human Resources experience 
  • Five (5) years of experience with ADP Workforce Now and Time and Attendance Platforms including setting up validation tables and coding within system 
  • Strong understanding of Human Resources best practices and the ability to effectively collaborate and work in team environment.
  • Excellent presentation, communication, and interpersonal skills
  • Excellent problem solving skills
  • Ability to multi-task in a high volume environment and exercise effective judgment while working at a fast pace
  • Sensitivity and creativity to changing needs, situations, and people
  • Able to establish and maintain healthy working relationships with people 
  • Excellent Excel skills
]]>
Thu, 10 Aug 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, 09 Aug 2017 00:00:00 EDT 0
<![CDATA[Principal Systems Engineer]]> The Principal Systems Engineer is responsible for the primary definition (specs) and architecture (systems design) of AED products.

 

Essential Responsibilities: 
  • While working with Marketing, develop the Product Design Inputs (PDI) that describe the system level requirements for a device. 
  • Develop or oversee lower level specifications (Module Design Inputs) that define the product.  
  • Create a complete requirements cascade that links all requirements from the PDI down to the BOM.  Forward and Backward traceability.  Participate in and oversee statistical capability analysis both internally and externally to assure development goals are sustainable long-term.
  • Assess verification testing to determine successful completion or assist with re-designs / re-tests / regressions as required.
  • Monitor detail designs with Design Engineering to assure designs meet MDI / PDI requirements
  • Interact with other team members, external consultants, partners, and clients at clinical and/or technical levels. 
  • Comply with company policies and procedures regarding Employee health, safety, and conduct.

 

Required Qualifications:
  • A Bachelor of Science degree in EE, SW or Biomedical Engineering
  • Minimum of 5 years in medical product development environments
  • Hands on skills in requirements cascade / traceability.   
  • Strong communication skills
  • Expert level competency in Microsoft Office suite
  • Expert level competency in requirements cascade software (DOORS or other)
  • Basic understanding of Six Sigma methodology and associated statistical analysis

 

 

Desired Qualifications:
  • AED industry knowledge
  • Medical Device industry experience including FDA Class 3 Pre-Market Approval (PMA) processes and similar requirements for other countries (e.g. IEC standards and technical file requirements   for CE mark).
  • Experience with tools for data analysis and algorithm development like MATLAB

 

Travel:  Less than 10%

 

Working Conditions:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Physical demands: While performing duties of job, employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Employee must occasionally lift and/or move up to 25 pounds.
  • Work environment: The noise level in the work environment is usually moderate.
]]>
Tue, 08 Aug 2017 00:00:00 EDT 0
<![CDATA[Risk Management Claims Administrator]]> Our client, based in Chicago near all public transportation, is looking for   Risk Management Claims Administrator for a two month project

Job Responsibilities: 

Use your knowledge of Workers Compensation to manage first reports of injuries to submit insurance claims 

 

Qualifications/Requirements:
  • 5+ years of experience working with insurance claims
  • Experience working with claims in FL and/or CA is ideal

 

 

 

 
]]>
Tue, 08 Aug 2017 00:00:00 EDT 0
<![CDATA[HR Manager]]> Our client,  a continuing care retirement community, is looking for an HR Manger in their La Jolla Village   facility.  If you’ re someone who has a desire to enhance the lives of others, grow your skills, and develop your career, we encourage you to explore this exceptional  career opportunity.  

Job Responsibilities:  
This selected candidate will be responsible for multiple aspects of the human resources function including but not limited to:
  • Recruitment
  • Compensation and Benefits
  • HRIS
  • Workers’ compensation and employee relations.
  • Implementation of  various programs by partnering with employees at all levels to ensure an educated and effective workforce.


Qualifications/Requirements:
  • Minimum of 5 years of generalist experience in Human Resources; Hospitality or senior living background preferred;  
  • Self-starter with ability to work as part of a team. 
  • Ability to organize and prioritize effectively to ensure timely completion of all responsibilities.  
  • Excellent analytical and deductive reasoning skills, good judgment, problem-solving skills and attention to detail. 
  • Strong oral and written communication and platform speaking skills. 
  • Ability to analyze and manage HR expenses. 
  • Knowledge of federal and state laws, compliance requirements. 
  • Strong interpersonal skills including the ability to manage external resources, (contractors, vendors, agencies, etc).
  • College degree; master’ s degree preferred.
]]>
Tue, 08 Aug 2017 00:00:00 EDT 0
<![CDATA[Senior Associate, Regulatory Affairs Post Approval]]> Responsible for support of post-approval regulatory affairs activities under direction of the department Manager.  Post-approval regulatory affairs activities may include but are not limited to:
  • Compilation/review of Annual Reports, Advertising/Promotional material, and product labeling
  • Electronic assembly and publication of original applications, amendments, and supplements
  • Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents.  

Success in the role is measured by:
  • Timely and accurate pre-submission review and electronic filing of FDA submissions including ANDA’ s, 505(b)(2)s, Amendments, Supplements, Annual Reports, DMF updates,  labeling changes, and Advertising/Promotional material
  • Timely and accurate review of change controls according to regulatory guidelines. 


Job Responsibilities:
  • Post-approval product support activities:  Compilation and review of FDA Submissions (e.g., Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with partners; and change control review/approval;
  • Coordinate compilation/review of Advertising/Promotional material with Marketing for Manager’ s review and approval.  Submit Advertising/Promotional materials to FDA’ s OPDP via electronic methods.
  • Domestic and international travel may be required.


Qualifications/ Requirements:
  • Bachelor’ s degree in a scientific area of interest (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing) or equivalent work experience preferred.
  • 4 or more years of direct pharmaceutical industry experience OR solid equivalent experience working in a cGMP and/or FDA regulated environment.
  • Direct responsibility for post-approval submissions to FDA, and for submitting ad/promo materials to FDA as well as hands-on experience reviewing and approving ad/promo materials.
  • Strong planning and organizational / project / workload management skills.
  • Ability to work under deadline pressure / rapidly shifting priorities, and manage multiple projects. 
  • Strong ability to work independently as well as in a team environment.
  • Ability to drive projects to completion with minimal guidance.
  • Solid interpersonal (verbal and written) communication skills at all levels.
  • Formal project management skills are a plus.
  • Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus.Regulatory publication experience using eCTD software is a plus.
  • Experience in the use of PC-based word processing software, databases, spreadsheets and Adobe Acrobat, including database management and support.
  • Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred.
  • Experience with metrics management and reporting.
  • Proven negotiation skills with internal and external stakeholders.  
]]>
Fri, 04 Aug 2017 00:00:00 EDT 0
<![CDATA[R&D Program Manager / Sr. Program Manager - Late Stage]]> My client is seeking a talented, motivated, and goal-oriented individual to join a growing Program Management team. The successful applicant will play an important role in supporting drug development teams.  This individual will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific projects/programs, and to facilitate communication across all parties.   The ideal candidate will have a scientific background and experience with clinical-stage drug development.  This role is highly cross-functional, and may involve close interaction with external partners.

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


Qualifications/ Requirements:
  • A 4-year degree and a minimum of 3-5 years of relevant work experience including some project or program management.
  • Late Stage drug development experience. 
  • Able to express ideas and present information clearly and effectively within teams, across functions, and with external partners.
  • Able to effectively lead team meetings and facilitate discussions within the team.
  • Demonstrate active listening and constructive feedback within team.
  • Ability to facilitate problem solving, decision making, and issue resolution.
  • Demonstrated analytical and technology skills, including proficiency in project planning tools, content management tools, and the Microsoft Office Suite.
  • Strong program management and organizing skills: 
  • Communicating across the organization to align on shared goals and responsibilities;
  • Working with teams to clarify vision and direction;
  • Developing work plans to meet goals;
  • Managing multiple projects at the same time;
  • Managing teams to meet goals and deliverables, tracking progress toward plan;
  • Highlighting areas of risk and developing mitigation plans;
  • Identifying options and facilitating decisions to enable projects to move forward;
  • Working with teams to develop budgets, and tracking progress towards plans;
  • Ability to plan and facilitate effective, efficient meetings, and prepare clear meeting minutes.
]]>
Thu, 03 Aug 2017 00:00:00 EDT 0
<![CDATA[Principal Medical Writer]]> The Principal Medical Writer is responsible for providing clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (eg. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions. Serves as the scientific writing content expert for the department.

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, approval, and other appropriate functions involved in the production of clinical regulatory projects.
  • Serves as a department representative on project teams.
  • Communicates deliverables needed, writing process, and timelines to team members.
  • Converts relevant data and information into a form that meets clinical regulatory document requirements.
  • Ensures all clinical regulatory electronic document deliverables are processed and compiled in alignment with timelines.
  • Assesses resource needs as timelines progress, and communicates those needs to department management.
  • Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors.  Ensures required documentation is obtained.
  • Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables.
  • Explains data in manner consistent with clinical regulatory requirements.
  • Confirms completeness of information to be presented. Challenges conclusions when necessary.
  • Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
  • 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.
  • Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments.
  • Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions.
  • Recommends, leads, and implements tactical process improvements.
  • Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with Regulatory on document strategies.


Qualifications/ Requirements:
  • Bachelor of Science required, with significant relevant writing experience, or Bachelor' s degree in English or communications, with significant relevant science experience.
  • 4 yrs relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.
  • High-level content writing experience and experience with all types of clinical publications or 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.
  • 2 years relevant industry experience preferred.
  • 4 years experience in experimental design and clinical/preclinical data interpretation preferred.
  • 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.
  • Extensive experience in working with collaborative, cross-functional teams, including project management experience.

Key  Competencies:
  • Builds strong relationships with peers and cross functionally with partners outside of the 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.
]]>
Thu, 03 Aug 2017 00:00:00 EDT 0
<![CDATA[Senior Manager, Clinical Operations and Development]]> My client is seeking a Senior Manager, Clinical Operations and Development. They will oversee clinical development programs (pre-IND through Phase 1-3 clinical trials). This key role will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans.  Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).  This position will report to the Associate Director of Clinical Operations.

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


Qualifications/ Requirements:
  • Master’ s degree preferred in a scientific or healthcare discipline
  • Minimum of 6-8 years in clinical and drug development in the pharmaceutical/biotech industry, at least 3 years of direct study management work preferred
  • Understanding of drug development from pre-IND through NDA
  • Extensive experience managing clinical programs, CROs, budgets, and timelines required
  • Strong working knowledge of MS Project and developing Gantt charts
  • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
  • Management of CROs, multiple vendors, and complex protocols
  • Protocol, ICF, and CSR writing experience required
]]>
Tue, 01 Aug 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.
]]>
Tue, 01 Aug 2017 00:00:00 EDT 0
<![CDATA[Sr. Associate, Regulatory Operations]]> Reporting to the Associate Director, Regulatory Operations, the Senior Associate of Regulatory Operations will assist with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document management. In addition to assigned projects, responsibilities include evaluation of current processes and systems with regard to industry best practices, available resources, and evolving U.S. and international regulations and guidelines. Then, based on such evaluations, propose changes targeting greater efficiency and continued compliance. This position will also be responsible for participating in day-to-day Regulatory Operation activities in support of the company’ s goals.

Job  Responsibilities:
  • Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities;
  • Provide detailed project timeline information to supervisor to support resource forecasting;
  • Coordinate and participate in the production of electronic regulatory submissions and, as required, paper submissions;
  • Develop proposals for system and process development or modification to support greater efficiency and continued regulatory compliance;
  • Assist with the development and implementation of processes related to submission standards, working practices, and quality controls;
  • Support and conduct cross functional training on submission standards and procedures as required;
  • Support compliance with worldwide submission regulations and guidelines.


Qualifications/  Requirements:
  • Demonstrated skills managing project timelines and organizing supporting resources;
  • Understanding of U.S. submission requirements; Understanding of international requirements a plus;
  • 4 years of pharmaceutical industry experience;
  • 4 years of experience compiling electronic submissions;
  • 4 years of experience in electronic document publishing;
  • Experience compiling IND, NDA/BLA, and CTD submissions;
  • Understanding of eCTD submission requirements;
  • Proficient with Microsoft Office products and Adobe Acrobat;
  • Advanced skills with submission publishing software;
  • Extensive experience using electronic document management systems;
  • Familiarity with system validation practices;
  • Bachelor’ s degree or equivalent experience;
]]>
Tue, 01 Aug 2017 00:00:00 EDT 0
<![CDATA[Associate to the President]]> The Associate to the  President’ s Office  provides high-level, high-quality administrative support to the President and works closely with the Senior Associate to the President to ensure that the President’ s Office runs effectively and efficiently.   In this role, you  must be able to anticipate, take initiative,  adapt to changing priorities, and must demonstrate the ability to be diplomatic, flexible, and discrete with confidential information.

Job Responsibilities:
  • Drafts correspondence for the President.
  • Develops and manages the President’ s Office file management plan and protocols for archiving and data management and improves upon the plan and protocols as needed.
  • Organizes and coordinates complex meetings (e.g., Partnership for Safe and Peaceful Communities and Neighborhood Economic Development Strategy Group).
  • Serves as back-up to the Senior Associate in scheduling calls and appointments with external stakeholders and contacts.
  • Serves as secondary point of contact for incoming calls to the President’ s Office.
  • In coordination with the Senior Associate, creates the administrative budget for the President’ s Office.
  • Manages consultant and vendor contracts.
  • Oversees the Speakers Series, including development of a pipeline of possible speakers.
  • Serves as the primary content creator for President’ s Office events and announcements on the Foundation’ s intranet and back-up content creator for the President’ s posts.
  • Manages grant approval activities for the President’ s Office, including creating quarterly dashboards for the President, entering Letters of Inquiry addressed to the President, and creating PDFs of grant briefs for President-approved administrative grants in the grants management system.
  • Plans for, manages, and creates the quarterly Board book for the Board of Directors.
  • Distributes Board Book and Committee Books, including posting to the Directors’ website.
  • Maintains an updated contact list for the Board of Directors and former Directors.
  • Responsible for procurement of gifts for the Board on special occasions.


Qualifications/Requirements:
  • Bachelor’ s degree or equivalent with at least six to eight years of experience in supporting high-level executives is required.
  • Must be able to execute complex projects with strong attention to detail and to manage multiple projects and tasks and meet deadlines.
  • Exceptional writing and editing skills are essential.
  • Strong organizational skills are essential.
  • Exceptionally strong proficiency in working in Microsoft Office (Word, Excel, PowerPoint, and Outlook), and a strong aptitude for learning new technology and programs is required.
  • Must be able to maintain knowledge on all organizational policies and procedures and stay informed and up-to-date on the activities and achievements of the Foundation.
]]>
Tue, 01 Aug 2017 00:00:00 EDT 0
<![CDATA[Program Lead, R&D, Drug Development]]> My client is seeking a Program Leader who is a creative, resourceful, integrative thinker to oversee two or more high priority neuroscience development programs as they transition from candidate selection into early clinical development.  The ideal candidate will possess demonstrated program experience leading early to late stage drug development programs through launch and life-cycle management in the field of psychiatry and neurology.

The Program Leader will be responsible for leading and managing novel drug development projects and teams to successful development, NDA submission and market introduction.  This individual will work closely with all levels of leadership to determine program strategies and with internal and external groups to resource and implement all aspects of a drug development project. The Program Leader will set strategies and implement operating plans for the organization and be responsible for the overall project budget. The Program Leader will have access to all levels of the Leadership Team and will work closely with all the functional areas to plan, resource, implement and monitor programs.

Job  Responsibilities:
  • Provide effective leadership and direction for drug development programs and lead the Program Team.
  • Serve as Program Leader on one or more Program Teams, providing a model for effective team leadership within a matrix environment.
  • Accountable for meeting targets and managing deliverables.
  • Develop, prioritize, document and communicate measurable annual and long range plans.
  • Work closely with Medical Sciences, Regulatory Affairs, and Commercial to set team strategies through the Program Team.
  • Work with the relevant functions to identity key development and commercialization issues, develop plans to support market introduction, and proactively develop plans to support life-cycle management.
  • Responsible for the management and delivery of an integrated development plan for the compound(s) and ensuring alignment across strategic, operational and tactical plans
  • Drives decision point planning and associated deliverables across all functions of the team Ensures the input from sub-teams to support the advancement of the program’ s objectives and deliverables
  • Assure that management is appraised, in a timely fashion, of the current status and issues surrounding each project.
  • Provide effective solutions for solving Program Team conflicts
  • Manage the program through effective budget planning and accountability, objective setting, performance appraisal and individual development, as appropriate.
  • Review and allocate resources in collaboration with functional areas and program teams
  • Provide sound strategic thinking related to regulatory interactions that lead to successful outcomes; attend key meetings with regulatory agency, as applicable.
  • Define and articulate clear strategic vision within program teams, serving as visible program champion and focal point for critical program information
  • Ability to design and influence new product concepts to R&D and the organization in general
  • Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses and ensure accurate information is provided for planning processes and resource allocation
  • Manage budget projections and timelines to establish annual goals and to scenario plan across multiple programs in collaboration with cross-functional departments.


Qualifications/Requirements:
  • 15 years’ solid scientific background in pharmaceutical drug development with at least 10  years of experience in a project management function, and 5 years in a team leadership role.
  • Advanced degree in life sciences; a PhD or MBA is a plus
  • Have a past record of achievement in leading and managing project teams and product development with a thorough understanding of the drug development process at a strategic level through the entire lifecycle.
  • This position requires an individual with outstanding organizational and interpersonal skills.  It is essential that this individual can manage relationships and achieve results through influencing others in the organization.
  • Highly developed negotiation skills.
  • Strong knowledge of program budget process and resource allocation.
  • Superior oral and written communication skills are required, as is the ability to function effectively with senior management.
  • A strong focus toward creativity, independent thinking and results orientation is required.
  • Leading programs toward successful NDA/ MAA submissions.
  • Must have high ethical standards and impeccable integrity.
  • Must have highly developed personal leadership style and confidence.
  • Must be able to apply independent thinking, organizational abilities and strong discipline in a dynamic environment.
  • Must have strong detail orientation and be hands-on when needed to do what it takes and achieve key objectives.
  • Ability to understand stakeholder concerns and frame issues/proposals to influence decision making
  • Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
  • Capable of managing multiple programs/brands simultaneously
  • Issue Identification and Resolution
  • Cross-Functional Coordination and Communication including senior management
  • Demonstrate and apply understanding of the interdependencies between various stakeholders within the drug development process including but not limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development program.
  • Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
  • Be a diplomatic professional, ‘ clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicine to patients.
  • 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 in a matrix environment, as well as with external partners and vendors.
]]>
Mon, 31 Jul 2017 00:00:00 EDT 0
<![CDATA[QC Reviewer-REMOTE]]> Our client is a global leader in the pharmaceutical industry.   They have experienced significant growth in drug development and need a  QC reviewer  available as project  needs arise.

Job Responsibilities:
  • Review clinical study reports for accuracy using QC checklist
  • Project turnaround time is typically four  to five days and average approximately 40 hours to complete
  • The team and processes are organized with reasonable process metrics
  • Excellent leadership and seamless relationship between medical writing and QC


Qualifications/ Requirements:
  • Three plus years of experience as a medical writing QC reviewer
  • Bachelor  of Science required or Bachelor of Communications/ English with science experience strongly preferred
  • American Medical Writing Association (AMWA) certificate or other similar credential is preferred, with a specialty in Pharmaceutical
]]>
Mon, 31 Jul 2017 00:00:00 EDT 0
<![CDATA[Assistant Director of Nursing]]> There’ s a reason you chose healthcare as your life’ s work. Our client, a Senior Living Community, would like to help you rediscover it. If there’ s a part of you that is looking for deeper levels of engagement with both residents and colleagues, we encourage you to consider joining   our client, as an ADON – in a place like no other with people like no other... a luxury work environment where opportunities for career development are delivered in ways few companies can match. 

Job Responsibilities:
  • The candidate selected for this dynamic role will oversee all aspects of care and services provided in the Care Center, which includes assisted living, memory support, and skilled nursing. 
  • As a natural leader, the professional serving as Assistant Director of Nursing will supervise the nursing staff and support the Director of Nursing with clinical, financial, human resource, and quality assurance/performance improvement activities.
     

Qualifications/Requirements:
  • 3+ years of experience with geriatric populations, to include knowledge of regulatory compliance and Continuing Care Retirement Community or Assisted Living/Memory Support operations
  • Prior supervisory experience strongly preferred
  • Graduation from an accredited school of nursing, current state licensure, and CPR/AED certification 
  • Excellent communication and interpersonal skills with a courteous and customer-centric approach to problem-solving and goal-setting
  • PC skills (MS Office) are a must
]]>
Mon, 31 Jul 2017 00:00:00 EDT 0
<![CDATA[Associate Director, PV Scientist]]> Our client is searching for an experienced Associate Director/Director Pharmacovigilance Scientist (AD/D PV Scientist) that is a creative, resourceful and integrative thinker. The person in this role works closely with the Global Safety Lead (GSL) and with the VP of Drug Safety and Pharmacovigilance and provides pharmacovigilance and signal detection expertise through contributions to clinical and post market pharmacovigilance deliverables and activities.

Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.   The AD/D PV Scientist will provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal management activities, safety and benefit-risk evaluations for assigned products, management of potential safety issues for assigned products, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries on product safety issues including oversight of aggregate reporting for all products within the product group.

Job  Responsibilities
  • Overseeing aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned product group
  • Lead product safety surveillance activities for assigned product(s)during all phases of the product life-cycle
  • Review study protocols, statistical analysis plans and other clinical study-related documents
  • Review standard design of tables, figures, and listings for safety data from clinical studies
  • Manage updates to Investigator Brochure, Company Core Safety Information and other Reference Safety Information
  • Signal detection, evaluation, and management
  • Implement signal detection strategy approved by GSL and VP of Drug Safety and Pharmacovigilance
  • Review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
  • Prepare review of potential safety signals for GSO and VP of PVRM
  • Provide safety contents for risk management plans
  • Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’ s business strategy, industry standards and compliance with global regulations


Qualifications/Requirements:
  • Advanced degree (RN, PharmD, NP, PhD, MD, MPH, NP, DVM with specialty board certification)
  • Minimum 6-8 years pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
  • Expertise in the following; Argus Safety Database, MedDRA, Sharepoint, Microsoft Office, Excel
  • Sound clinical acumen and decision making
  • A proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency.
  • Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information
  • Expertise in international regulations governing drug safety (US and EU) for pre and post-marketing
  • Demonstrated leadership and collaborative skills necessary to influence across functions and earn credibility across a complex and rapidly growing organization.
  • Level will be commensurate upon experience and qualifications.
  • Excellent oral and written communication skills
  • Prior experience contributing to the development (process improvement, training, etc.) of a drug safety would be desirable
]]>
Fri, 28 Jul 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.
]]>
Thu, 27 Jul 2017 00:00:00 EDT 0
<![CDATA[Recruiting Coordinator]]> The Recruiting Coordinator supports our client’ s recruiting initiatives. This person touches many parts of the recruitment process including sourcing candidates for entry level positions, scheduling candidate interviews, and coordinating paperwork.

Job Responsibilities:
  • The Coordinator works primarily with the recruiting team, but also interacts with colleagues on other teams
  • The person in this role needs to be ready to roll up their sleeves and dive in to help with anything and everything.
  • Play an integral part on the team by identifying candidates for current and future talent needs as the company continues to grow.
  • Proactively engage both active and passive candidates using a variety of resources
  • Ensure timely communication with candidates and hiring managers through each stage of the hiring process
  • Candidate must have a positive attitude, be resourceful and a self-starter.
  • Strong written and verbal communication skills are a must.
  • Expected to be detail oriented and focused; seeing projects through to completion.
  • Be incredibly organized in order to work on multiple projects simultaneously, prioritize work appropriately, and handle competing deadlines.
  • Utilize the ATS to track and report all recruiting efforts


Qualifications/ Requirements:
  • A minimum of 2-3 years of full life cycle recruiting
  • Retail experience a plus
  • Excellent communication skills
]]>
Wed, 26 Jul 2017 00:00:00 EDT 0
<![CDATA[Contract Recruiter]]> Our client is looking for a team-oriented recruiter who can quickly build trusting relationships with HR, hiring managers and candidates. The ideal candidate will be focused on accountability, building and managing strong relationships, collaboration, and results.

You will have responsibility for full life cycle recruiting to staff open requisitions and willing to assume responsibility for recruiting based programs that may include – background checks, VMS / contingent workforce hiring and other 3rd party vendors related to staffing.

Job Responsibilities:
  • Manage the overall recruitment process and day-to-day activities; act as functional point of contact
  • Work with hiring managers to understand the job and to determine target companies and sources
  • Creatively source candidates and build a candidate pipeline for high-demand roles through web sourcing, networking, leveraging group research, candidate referrals, etc.
  • Pre-qualify and present candidates for interviews
  • Determine and deliver offer
  • Effectively close selected candidate
  • Regular follow up with hiring managers and candidates to ensure timeliness of recruitment process
  • Manage applicant tracking system and related data and reporting
  • Ensure recruiting related metrics are tracked and reported
  • Partner with Finance on headcount report
  • Proactively participate in Affirmative Action and EEOC outreach programs


Qualifications/ Requirements:
  • BA/BS degree or equivalent practical experience
  • 3-5 years recruitment experience (corporate and agency ideal)
  • Familiarity with ATS technology
  • Understanding and management of the end-to-end Talent Acquisition (TA) life-cycle -- outreach to on-boarding
  • Experience partnering with vendors for background checks, job boards and social media, and VMS
  • Experience developing and managing TA metrics preferred
  • Strong verbal and written communication 
  • Excellent cross-functional collaboration
  • Deadline driven/ results-oriented
  • Self-motivated with excellent customer service
  • Ability to partner and collaborate with key stake holders, external vendors, and customers while preserving confidential information
  • Ability to effectively operate with high energy and flexibility in a fast-paced, constantly evolving team environment
]]>
Wed, 26 Jul 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
]]>
Tue, 25 Jul 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, 25 Jul 2017 00:00:00 EDT 0
<![CDATA[Director of Compensation and Benefits]]> Our Client currently has an opportunity for a Director of Compensation and Benefits responsible for designing, developing and implementing efficient and effective compensation and benefit programs to meet current and future business needs and maintain a competitive advantage for the business as a whole. 

Job Responsibilities:
  • Analyze the effectiveness of existing compensation policies, guidelines, and procedures, recommending plan revisions, as well as new plans which are cost effective and consistent with compensation trends and corporate objectives; drives implementation and provides guidance to Sr. Executives, Management and HR staff.
  • Partner closely with company business leaders on a variety of compensation and benefit matters, including those related to the Company' s expansion initiatives.
  • Be on the forefront of evolving practices related to all aspects of Total Rewards; provide expert counsel and guidance to senior management on programs that are competitive in the industry and frequently benchmark best practices.
  • Ensure that all aspects of plan design and administration remains in compliance with applicable Federal, State and Local rules and regulations.
  • Provide recommendations to Sr. Executives, Management and HR staff on pay decisions, policy and guidelines interpretation and job evaluation, including the design of creative solutions to specific compensation-related programs.
  • Manage the administration of direct compensation (executive, exempt and nonexempt, cash compensation programs) including the processing, recording and reporting of compensation-related actions taken on salaried employees.
  • Direct the participation in market relevant exempt and nonexempt salary surveys to ensure corporate compensation objectives are achieved.
  • Manage the merit and bonus processes and makes program design recommendations based on relevant market data as defined by company compensation philosophy.
  • Research, analyze and recommend modifications to existing benefits plans to improve services to employees in a cost effective manner.
  • Oversee benefit plan contract negotiation meetings with vendors.
  • Recommend and help implement enhancements to benefits and compensation modules in the HRIS.
  • Partner with our corporate communications team as it relates to employee benefit communications.
  • Partner with our FK Global HR colleagues to implement global strategies and requirements. 


Qualifications/ Requirements:
  • Bachelor’ s degree; Masters preferred; Professional Certification desired
  • 7-10 years of management experience in compensation and benefits
  • Knowledge of HRIS and payroll systems
  • Advanced skills in Microsoft Excel and Word
  • Excellent verbal and written communication skills
  • Ability to communicate effectively with all levels of the organization
]]>
Tue, 25 Jul 2017 00:00:00 EDT 0
<![CDATA[Recruiter]]> The recruiter will play an integral part on the team by identifying candidates for current and future talent needs as the company continues to grow. Success in this role will be defined by the quality of service to the hiring managers and the ability to consistently place top talent in the appropriate roles.

Job responsibilities:
  • Perform full cycle recruiting activities from entry level roles, as well as managers
  • Positions will range from Food service folks, restaurants,  retail environment
  • Ability to work in a metrics driven environment
  • Proactively engage both active and passive candidates using a variety of resources
  • Ensure timely communication with candidates and hiring managers through each stage of the hiring process
  • Utilize the ATS to track and report all recruiting efforts


Qualifications/ Requirements:
  • A minimum of 3 years of full life cycle recruiting
  • Retail experience a plus
  • Excellent communication skills
  • Excellent follow up
]]>
Fri, 21 Jul 2017 00:00:00 EDT 0
<![CDATA[Assistant VP - Financial Reporting]]> This position will report to the Vice President of Financial Reporting.  The role includes leading external and internal reporting processes, maintaining accounting policies, and addressing accounting inquires for an industrial real estate platform spanning multiple investment portfolios and geographic markets.  This role requires coordinating and liaising with multiple levels of management and the external auditors, coordinating the flow of information, and the compilation and writing of GAAP/IFRS compliant financial statements.  This position also includes technical accounting and research in order to provide management with timely information for decision-making and analysis.  It will manage significant projects such as new policies, new types of transactions, impairment testing and training initiatives. 

This position will entail a significant amount of coordination between various corporate departments including Finance, Property Accounting, Accounts Receivable, Accounts Payable, Treasury, Legal, Lease Administration, and Tax, as well as a geographically dispersed team of field personnel.  Candidate is expected to possess strong communication skills along with the ability to work under tight deadlines and in a fast paced environment.  Analytical skills are a must along with a proficiency in synthesizing large quantities of data using Excel or similar tools. 

Job Responsibilities:
  • Coordinates and prepares monthly and quarterly internal and external financial information and reporting in accordance with US GAAP and IFRS.
  • Lead the annual impairment testing for Investments in Real Estate.
  • Monitor US GAAP and IFRS developments and evaluating the impacts of new accounting and reporting rules.
  • Evaluate the proper accounting treatment for complex or non-standard transactions and stay abreast of technical accounting issues pertaining to the real estate industry.
  • Develop and update accounting policies, as well as necessary internal communications on accounting policies and US GAAP updates.
  • Assist with accounting research efforts, including the development of position papers on accounting matters.
  • Provide guidance and support to corporate and operating company personnel on technical financial matters (e.g. purchase price accounting, accounting for leases, stock compensation, income taxes, impairment, environmental liabilities, acquisitions and dispositions)
  • Assist in special projects related to reporting issues, budgets, acquisition and disposition activity, accounting and reporting, as they become necessary.
  • Liaise with external auditors and coordinate annual audit.
  • Ad-hoc projects and analysis as assigned.
  • Communicates with various departments within organization as needed in regards to analysis and reporting.


Qualifications/Requirements:
  • Minimum of 8 years of total experience, with “ Big Four” or national accounting firm audit experience preferred, with strong US GAAP and IFRS accounting experience
  • Commercial real estate experience preferred
  • Fund/portfolio consolidating or REIT financial reporting experience in public accounting and/or industry
  • Strong project management experience
  • Very strong communication skills, both written and verbal (including public speaking skills)
  • Excellent interpersonal and conflict management skills
  • Ability to work efficiently and achieve results, while maintaining high quality
  • Excellent analytical, teamwork, customer service and leadership skills
  • Proficient in Microsoft Excel
  • Familiarity working with General Ledger accounting software (e.g. JD Edwards)
  • Entrepreneurial attitude
  • Ability to multi-task and work under tight deadlines and with competing priorities, as well as adapt quickly to changing circumstances
  • Exceptional work ethic
  • Bachelors and/or Master’ s Degree in accounting or equivalent
  • CPA required
]]>
Fri, 21 Jul 2017 00:00:00 EDT 0
<![CDATA[HR Consultant]]> Job Responsibilities:
  • Provide some strategic support to functional leadership on people initiatives
  • Develop in conjunction with the Executive Director and Administrative Director a   performance management process to include annual goal setting, updated job descriptions, and a timeline for annual performance reviews.  
  • Advise on organizational design; counsel on people and talent issues; assess organizational capabilities, and develop plans to close capability gaps.
  • Resolve complex, moderate-risk employee relations issues. Escalate to senior management as appropriate.
  • Other duties as assigned


Qualifications/ Requirements:
  • Bachelor’ s Degree required
  • Minimum of 10 years’ experience required
  • PHR or SPHR preferred
  • Strong attention to detail
  • Strong writing and communication skills
  • Ability to build new systems, processes and procedures as it related to managing talent
  • Competent at working independently and collaboratively
]]>
Thu, 20 Jul 2017 00:00:00 EDT 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.
]]>
Mon, 17 Jul 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.
]]>
Mon, 17 Jul 2017 00:00:00 EDT 0
<![CDATA[Sr. Compensation Analyst]]> Job Responsibilities:
  • Administers the annual focal point review process for merit and incentive awards.
  • Makes recommendations to managers regarding base salary levels, appropriate salary range assignments, total compensation opportunity, and/or hiring ranges for positions.  Consults with talent acquisition team regarding pay decisions including policy and guideline interpretation.
  • Responsible for day-to-day administration of compensation plans and policy documentation.
  • Completes third party market and salary survey submissions; manages internal survey library.
  • Analyzes internal and external salary and wage data, completes job evaluations, and recommends pay ranges and job titles in accordance with established company structure and guidelines.
  • Participates in the development of a compensation structure and rollout.
  • Drafts and coordinates communication of compensation messaging and announcements related to annual salary and wage planning, routine compensation analyses, and related initiatives.
  • Prepares and maintains company-wide job description records; develops and maintains job description reference library.
  • Participates in compensation budget planning activities, taking into account market conditions and Company’ s budgetary constraints.
  • Manages policy and procedure development regarding compensation practices.  Leads process and system improvement initiatives to better facilitate accurate data, analytics, and streamline compensation processes.
  • May support mergers and acquisitions by developing compensation proposals for employee transitions and alignment of compensation programs.


Qualifications/ Requirements:
  • Bachelor’ s degree with concentration in Human Resources, Business or Finance
  • 5-7 years at an analyst level or above in the compensation field
  • Certified Compensation Professional preferred
  • Excellent communication, interpersonal, analytical, problem solving, mathematical, and organization skills
  • Proven ability to communicate with all levels within the organization
  • Microsoft skills including Excel, Word, PowerPoint and Outlook
  • Experience with ADP HR system preferred
  • Strong project management skills with team orientation and collaborative style
  • Hands-on in-depth experience managing compensation program implementation and roll-out
  • Ability to work independently and respond to deadlines
  • Demonstrated ability to manage multiple projects
  • Strong consultative skills and highly effective in communicating clearly and persuasively with top-notch influencing skills
  • Ability to read, write and speak English proficiently
  • Specific vision requirements include the ability to see at close range, distance vision, peripheral vision, depth perception, and the ability to adjust focus
  • While performing the duties of this job, the employee is regularly required to talk and hear
  • Possess the ability to fulfill any office activities normally expected in an office setting, to include, but not limited to:  remaining seated for periods of time to perform computer based work, participating in filing activity, lifting and carrying office supplies (paper reams, mail, etc.)
  • Frequently required to stand, walk, sit, use hands to feel, and reach with hand and arms
  • Occasionally lift and/or move up to 20-25 pounds 
  • Fine hand manipulation (keyboarding)
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Mon, 17 Jul 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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Fri, 14 Jul 2017 00:00:00 EDT 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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Fri, 14 Jul 2017 00:00:00 EDT 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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Fri, 14 Jul 2017 00:00:00 EDT 0
<![CDATA[Director, Human Resources]]> Serve as a member of senior management in implementing strategic direction and designing an efficient organization.  Directs the development, implementation and utilization of Human Resources’ policies and processes necessary to provide the organization with a productive work climate and a capable work force that includes the necessary number of employees who are qualified, motivated and rewarded for their contributions to company objectives.  Operates within the requirements of competitiveness, cost efficiencies and legal/statutory considerations.  Guide the provisions of proactive services in recruitment/staffing, employee relations, compensation/awards, benefits administration, employee/management development, employee safety, and HR technology systems.

Job Responsibilities:
  • Develops, and continuously updates, the HR Strategic Plan in order to determine the programs and processes needed, the standards for their development and effectiveness evaluation and the scheduling of their implementation in order to proactively meet the company’ s human and organizational improvement needs.  
  • Represent Human Resources on the Leadership team as it relates to new growth opportunities and expansion.
  • Consults with senior Leadership to improve their capabilities for recognizing and reducing organizational and cultural conflicts and inhibitors and successfully leading ongoing change implementation. 
  • Guides the sourcing, recruitment and selection of employees in order to provide the company with the necessary new talents and skills to meet organizational change and growth requirements. 
  • Develops and implements effective hiring, orientation and termination procedures.
  • Directs the development, implementation and communication of employee related policies that serve as the foundation for guiding management in the fair treatment of employees; counsels with management in the positive resolution of performance deficiencies, corrective discipline and termination actions. 
  • Directs the development and implementation of base pay and incentive awards programs that are market competitive and internally equitable while appropriately recognizing performance and contribution.  Also, guides the implementation of non-monetary recognition programs to reinforce valued service and contributions.
  • Manages the administration of health, life, disability and workers’ compensation insurance programs, retirement and savings programs in a manner that is responsive to employees, meets regulatory guidelines and budgetary constraints. Communicates benefit programs in a comprehensive, understandable method
  • Guides the process to ensure that employees’ technical, professional and managerial training and development needs are being met to include needs assessment, design of programs, selection of providers, and evaluation of effectiveness.
  • Ensures that processes are in place to support continuous organizational learning through the development of employee performance measurement/evaluation processes, management and employee succession/development plans that will support the company’ s continuing growth.
  • Guides and promotes safe work performance by developing safety systems, policies, and procedures; developing safety campaigns, communications, and recognitions.  Analyze and disseminate Work Comp information and trend data to Senior Leadership.
  • Works to ensure that efficient Human Resources information systems are in place to meet transactional and data requirements.
  • Manages the centralization and standardization of job requirements by maintaining a central database for job descriptions, CV’ s and Organization Charts. 
  • Establishes, tracks and analyzes departmental metrics and data that support the accomplishment of the company' s strategic goals and drive program design.
  • Interact with legal counsel, government agencies, compliance committees, senior management, employees, vendors, and providers to ensure an understanding of the organization’ s initiatives towards compliance.

Management Responsibilities:
  • Performs those administrative activities necessary for the effective management of the department, including provision for the selection and development of employees, salary and budget administration, employee counseling and motivation, disciplinary action, organization of goals and objectives, and planning, organizing, integrating and measuring the work performed within the department.


Qualifications/ Requirements:
  • Bachelor’ s in Human Resources or comparable degree required.
  • Advanced professional preparation MBA, Master’ s degree in Human Resources or comparable degree preferred.
  • A minimum of (5) five years of progressive multi-site, multi-state leadership experience.  Healthcare industry experience is preferred.
  • Experience in a growth oriented environment.
  • History of successfully standardizing key human resource, operational and administrative components within organization.

Behavioral Skills:
  • Possess a personal presence characterized by a sense of honesty, integrity and caring with the ability to inspire and motivate others to promote the philosophy, vision, goals and values of the company.
  • Demonstrated experience as a change agent that can drive organizational excellence.
  • Strong business acumen with ability to show ROI and/or rationale for business decisions.
  • Strong communication and presentation skills with a proven ability to influence and lead teams to conclusion/decision making.
  • Demonstrated ability to collaborate with a diverse population.
  • Proven ability to think strategically by designing global concepts, but also must be able to lead day-to-day tactical processes.
  • Ability to cope with mental and emotional stress related to the position, function independently, having flexibility, consistency and professionalism.
  • Must demonstrate on an ongoing basis the ability to develop and maintain good working relationships with staff and leadership.
  • Exhibits safe, positive and productive work habits.
  • Demonstrates compliance with all policies and procedures.

Technical Skills:
  • Thorough knowledge of state and federal employment regulations.
  • Strong compliance background, experience with EEO, Title VII, FMLA, and ADA
  • Proficient in the implementation and maintenance of HR Information Management Systems, ie Lawson, PeopleSoft, etc.
  • Knowledge of payroll systems, ie ADP, Namely, Kronos
  • Proficient in Microsoft Office applications

Physical Requirements:
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Frequently required to carry or lift items weighing up to 10 pounds.
  • Occasionally required to carry or lift items weighing up to 25 pounds for short distances.  Required to obtain assistance of another qualified employee when attempting to lift objects over 25 pounds.
  • Occasionally required to stand or walk.
  • Frequently required to sit in a stationary position.
  • Occasionally performs activities that require stooping, bending and reaching, squatting, balancing, and trunk twisting throughout the day.
  • Constantly able to communicate verbally and in written form.
  • Frequently able to detect and discern both loud and soft sounds such as phone calls and customer questions.
  • Constantly able to use hands and fingers to type, write, and file.
  • Frequently able to use near vision for viewing computer monitor and written materials.
  • Occasionally required to detect unusual odors that could indicate environmental issues.
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Wed, 12 Jul 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%
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Thu, 06 Jul 2017 00:00:00 EDT 0
<![CDATA[Clinical Research and CME Manager]]> Reporting to the Vice President, Chief Quality Officer, the manager is responsible for the day – to – day operations of the Clinical Research and Continuing Medical Education Department. Provides expert guidance and facilitation of research and CME activities and promotes the expansion/growth of the programs.

Job Responsibilities:

Clinical Research Program
  • Responsible for the overall direction and oversees the daily operations, strategic planning and continued growth of the clinical research department, as well as responsibility for financial oversight of department.
  • Manages the study review and approval Process for the company, including assessment of all study-related documents (protocol, consent form(s), risk assessment form, IRB application, Company application), and coordinates with research financial personnel for the development of budgets for hospital charges to Principal Investigators. Works with Grants & Contract Specialist to ensure that study-related contracts are consistent with the protocol and with all study operational details
  • Is responsible for leading the research credentialing process for all applicants and for insuring timely completion of the credentialing process.
  • Leads or participates in the clinical research education programs to educate investigators, nurses, and other research team members and support personnel.
  • Maintains an updated and accurate Research Database, and insures that standard reports are completed and disseminated on schedule.
  • Works with the Vice President to trouble-shoot and resolve internal compliance issues or questions pertaining to human subject research, including highly-confidential investigations.
  • Maintains and updates the Federal wide Assurance with the Office of Human Research Protections, DHHS. Ensures that IRBs are registered on the Federal wide Assurances or that a Single Use Authorization is executed.
  • In conjunction with the VP/Chief Quality Officer, assists in developing strategic operational goals, initiatives, and programs that are aligned with hospital objectives, and business development plans. Prepares monthly activity reports.
  • Promotes individual professional growth and development by meeting requirements for mandatory/continuing education, skills competency, supports department-based goals which contribute to the success of the organization; serves as preceptor, mentor, and resource to less experienced staff.

CME Program
  • Manages the day-to-day activities related to all AMA PRA Category 1 CME activities planned by the CME office. Maintains accurate financial records relating to all CME expenditures.
  • Works with the Education Committee Chairman to ensure compliance with ISMS Essential Areas, Elements and Guidelines for all CME activities.
  • Completes comprehensive educational grant applications from pharmaceutical companies and outside organizations. Collaborates with Marketing, physicians and/or outside vendors to design, review and distribute promotional materials. Serves as point-person for all Audience Response System presentations.
  • Maintains accurate financial records and oversees CME tracking systems. Prepares agendas, attends meetings, records and transcribes quarterly Education Committee meeting minutes. Compiles the annual report of CME activities for the ISMS and the Medical Executive Committee. Networks with other CME providers to learn of “ best practices” that can be implemented to improve the overall process of CME activities.
  • Adheres to all Hospital standards, policies, and procedures.


Qualifications/ Requirements:
  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (ie, registered nurse).
  • 3 - 5 years of clinical research experience required, including at least 2 years’ experience in clinical trial management
  • Experience with clinical trial planning, (site) management and metrics
  • A solid understanding of FDA regulations on Good Clinical Practice, Declaration of Helsinki, and International Conference on Harmonization requirements. Knowledgeable of relevant FDA, NIH, CMS, OHRP, HIPAA and other clinical research and human subject regulations and guidelines. Able to interpret regulations for appropriate operational implementation for all types of research studies (retrospective chart reviews, observational, registry, interventional, IND or IDE or Compassionate Use).
  • Experience managing CME activities according to ACCME and/or ISMS policies preferred.
  • Licenses/Certifications: Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP), Certified IRB Professional (CIP), or Certified in Healthcare Research Compliance (CHRC) preferred.
  • The interpersonal skills necessary to interact effectively with all levels of staff, physicians, external contacts and patients.
  • Excellent verbal and written communication skills necessary to prepare, develop and present information in a clear and concise manner.
  • The leadership skills necessary to delegate appropriately and direct research activity of staff to effectively motivate and maximize staff performance.
  • The analytical and problem solving skills to do financial and budget planning.
  • Organizational skills to manage multiple tasks as they relate to research trials.
  • Excellent time management skills
  • Mathematical skills to do financial planning.
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Wed, 05 Jul 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[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
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Thu, 15 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
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Fri, 09 Jun 2017 00:00:00 EDT 0
<![CDATA[Director of Nursing]]> Our client in the Northwest Suburbs is looking for a Director of Nursing:

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


Qualifications/ Requirements:
  • Full-time RN who has knowledge and training in nursing administration and restorative/rehabilitative nursing.
  • Knowledge and training of geriatric residents.
  • Graduate of an accredited nursing program with an Illinois RN license.
  • CPR certified
  • Possess excellent communication skills
  • Nursing Home Administrator’ s license is a plus
  • Must be able to read, speak and understand the English language.
  • Must be able to propel a patient / resident in a wheelchair.
  • Must be able to move items at least 15 pounds.
  • Must be able to assist patients /residents in evacuating the building in an emergency
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Mon, 22 May 2017 00:00:00 EDT 0