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Senior Specialist, Medical Affairs Strategic Operations

OperationsOperationsFull TimeRemoteTeam 1-10H1B SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

18 days ago

Salary

$103.1K - $175.3K / year

Bachelor Degree3 yrs expEnglish

Job Description

• Management of the review process for non-interventional studies, independent publications, local data generation and investigator-initiated studies • Ongoing oversight of investigator-initiated studies • Management of Independent Medical Education grants (US only) • Manage the Non-registrational Study Approval Process (NORSAP) for all therapeutic areas • Engage with internal and external stakeholders to ensure completeness of submissions to the NORSAP Committee • Ongoing management of approved Investigator Initiated Studies (IIS’s) • Oversees and executes on the end to end US Independent Medical Education grants review and approval process • Ensures compliance with existing internal and external guidelines

Job Requirements

  • At least 3 - 5 years of operations support in Pharma or similar background
  • Vendor Management
  • Preferred experience with Investigator Initiated Study Management
  • Preferred experience with Independent Medical Education (US)

Benefits

  • retirement savings plan
  • paid vacation and holiday time
  • paid caregiver/parental and medical leave
  • health benefits including medical, prescription drug, dental, and vision coverage

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