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18 days old

Medical Director

Kelly Services
Titusville, NJ 08560
Kelly FSP is hiring a **Medical Director** to work directly with one of our major pharmaceutical clients. This role is a full-time, salaried opportunity offering our enhanced benefit package. As a Kelly employee within this group, you will be eligible for our benefit options including Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All Kelly FSP employees receive annual performance reviews.


Please send your resume to Alicia Cali at alic019@kellyservices.com or call/text at 216.256.7768


**PRINCIPAL RESPONSIBILITIES:**


+ Product Safety Profile and Risk Management Oversight for assigned Therapeutic Areas Provide input into discussions on emerging safety concerns at relevant forums Contribute to the preparation of regulatory actions in response to emerging safety concerns.

+ Provide strategic medical and regulatory input to product teams and Risk Management Scientific Leads during the preparation of core and EU Risk Management Plans RMPs.

+ Provide guidance to Safety Management Teams SMTs during the preparation of responses to high-profile requests such as Referral procedures from National Competent Authorities NCAs and the European Medicines Agency EMA for information necessary for the benefit-risk evaluation of a medicinal product.

+ Maintain oversight of the formal documentation of any conditions or obligations adopted as part of the MAs and other commitments relating to safety or the safe use of the products, risk minimization measures, and PASS requested by a NCA including the results of such studies 50 Benefit-Risk Oversight PV System Compliance.

+ Engage with key functional stakeholders to optimize the provision of oversight and key metrics for the performance of activities to monitor the benefit-risk profiles of the company s authorized products.

+ Evaluate the provisions for meeting PV obligations within Post Authorization Safety Studies PASS protocols that require approval by the QPPV, and the status of such studies.

+ Maintain oversight of the status of key commitments to regulatory authorities, including Post-Authorization Commitments and Health Authority Queries Maintain oversight of compliance with the requirements of regulatory authority.

+ Assessment Reports for PBRERs/PSURs Management/Mentoring Activities.

+ Direct management responsibilities may be assigned as required within the organizational requirements of the QPPV Office. In addition, close collaboration with colleagues managing the PSMF is required with regard to oversight of PSMF-related activities.

+ Participate in internal and external groups for networking, intelligence gathering and input, as agreed with the QPPV Pharma Support the QPPV


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-11-19 Expires: 2021-12-20

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Medical Director

Kelly Services
Titusville, NJ 08560

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