Hiring for Sr. Medical Affairs Manager in West Chester, PA 19380
Location
West Chester, PA | United States
Job description
Job Title: Sr. Medical Affairs Manager
Location: West Chester, PA 19380
Duration: 12+ months of contract
Salary: $40/hr - $47/hr
Qualifications:
- Bachelor's degree in Biomedical Sciences, Pharmacy or similar
- 3 years of experience in Industry with relevant medical affairs experience and/or clinical trial experience Strong interpersonal skills with experience in project management, organization and tools
- Preferred: 5 years of experience in Industry with relevant medical affairs experience and/or clinical trial experience.
Essential Duties & Responsibilities:
- Global study oversight and tracking for Medical Affairs Company sponsored studies and evidence generation activities.
- Act as operational support for regional and local Medical Affairs teams to assist with study start up activities in partnership with GCO and Procurement; e.g. SDC/protocol development, vendor selection, convene study team, prepare and support governance presentations
- Support quality initiatives including inspection readiness oversight for Medical Affairs Studies as well as development and support of quality process and procedures.
- Represent GMA in the review and development of various procedural documents related to late-phase Global Medical Affairs studies, inspection readiness and quality in alignment with the R&D GCO, Innovative Medicines, Clinical Development, Pharmacovigilance, Global Clinical Quality, GMA therapeutic area teams.
- Development and refinement of relevant policies, SOP and Work Instructions as applicable
- Sponsor Therapeutic Area review of ongoing studies to facilitate knowledge sharing, status updates and critical issue identification.
- Oversee Vendors to ensure accurate service delivery, required process or system updates and ensure continuous service/support.
- Provide support for Investigator Sponsored Studies, Collaborative Research and Compassionate Use programs as needed.
- Provide support for GMA Excellence & Evidence Generation initiatives as requested
- Provide system support (clinical trial management system, intake portals) as needed.
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