Medical Science Contractor for Late-Stage Brands

4 weeks ago


Trenton, New Jersey, United States Omni Inclusive Full time
Job Summary:

Omni Inclusive seeks a highly skilled Medical Science Contractor to provide medical oversight for late-stage brands. The ideal candidate will have a strong background in medicine and pharmaceutical products, with experience in post-marketing safety and regulatory guidelines.

Key Responsibilities:

  • Lead medical input for brand cross-functional teams, providing expertise on pharmacovigilance and safety monitoring.
  • Develop and propose labeling recommendations based on signal detection activities and pharmacovigilance findings.
  • Conduct medical assessments of risk/benefit for assigned products, including new indications, safety or stability issues, and medical necessity/sensitivity assessments.
  • Provide medical input for regulatory requirements, including responses to health authorities and support for registration renewals and label periodic reviews.
  • Collaborate with cross-functional partners to develop and maintain accurate and compliant medical information.
  • Support the development of medical communications, including Dear Healthcare Professional letters and Clinical Overviews.

Requirements:

  • MD or equivalent required.
  • Board certification and medical specialty highly preferred.
  • 2-4+ years in clinical practice.
  • 1-2+ years of pharmaceutical industry experience required, with 5+ years preferred.
  • Experience in clinical safety and pharmacovigilance strongly preferred.


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