Physician Reviewer

5 days ago


Silver Spring, Maryland, United States AE Strategies Full time

Job Summary:

The Clinical Trials Reviewer is a key position at AE Strategies, requiring a physician with expertise in regulatory affairs and clinical trials. This role involves reviewing new drugs to ensure their safety and efficacy, working closely with the team to make evidence-based decisions, and staying up-to-date on scientific advancements.

Responsibilities:

  • Pre-Approval Reviews: Conduct thorough reviews of new drug applications to ensure their design is sound and backed by strong animal testing.
  • Approval Evaluations: Evaluate clinical trial results and labeling accuracy to ensure the drug works as intended and has clear instructions and warnings.
  • Post-Approval Reviews: Review updates, safety reports, and potential new uses or label changes for existing drugs.

Requirements:

  • Education: US or Canadian Medical Degree (MD, DO, or equivalent) from an accredited school or Foreign Medical Degree (MD or equivalency) with ECFMG certification or USMLE completion.
  • Licensure: Current, active, full, and unrestricted medical license in the US or its territories.
  • Experience: Ability to apply clinical and scientific knowledge to complex medical problems and benefit/risk management, with a strong desire to stay current on the latest clinical information in the assigned therapeutic area.


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