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Research Associate II
Ref No.: 18-15708
Location: Collegeville, Pennsylvania
Job Description: (Re-post from Req 12387)

JOB TITLE: Epidemiologist Contractor

• Propose and carry out various components of Epidemiology deliverables for development and product teams, including:
- Epidemiology Research Strategy
- Epidemiology section of the Risk Management Plan (RMP) and Pediatric Investigational Plan (PIP)
- Epidemiology sections for other regulatory documents (e.g., ad-hoc regulatory requests)
- Background epidemiology studies, natural history of disease studies and user characterization studies
- Post-approval safety studies and their feasibility assessments
- Other epidemiology studies (e.g., special subpopulations, new indications)
• Participate in Risk Management Committee activities and apply epidemiologic methods to address safety and benefit/risk issues
• Provide critical assessment of epidemiological data and literature relevant to safety issues
• Conduct quantitative analyses of public use and private data sources as needed
• Present and publish results of epidemiological studies at scientific conferences and peer-reviewed journals
• Support multiple product teams on epidemiology related issues
• Work collaboratively with key stakeholders internally and externally
• Interact with regulatory agencies on epidemiologic issues as needed
Position Comments visible to MSP and Supplier: We are looking for an Epidemiologist (preferably with a PhD, DrPH or ScD)