Medical Review Specialist

2 weeks ago


Silver Spring, Maryland, United States AE Strategies Full time

Transforming Healthcare Through Regulatory Expertise


AE Strategies is seeking a highly skilled Medical Review Specialist to join our team in collaboration with the FDA. This full-time position requires the ability to work in a hybrid environment, with a strong preference for candidates residing within commutable distance of the FDA Headquarters in Silver Spring, MD.


Key Responsibilities:


As a Medical Review Specialist, you will be responsible for reviewing new drugs to ensure their safety and efficacy. This involves:



  • Pre-approval reviews: Evaluating the drug's design and animal testing to ensure soundness and efficacy.
  • Approval and labeling reviews: Analyzing clinical trial results and labeling accuracy to ensure the drug works as intended and has clear instructions and warnings.
  • Post-approval reviews: Reviewing updates, safety reports, and potential new uses or label changes.

Requirements:


To be considered for this role, you must have:



  • A US or Canadian Medical Degree (MD, DO, or equivalent) from an accredited school.
  • Foreign Medical Degree (MD or equivalency) with ECFMG certification or USMLE completion.
  • Ability to apply clinical and scientific knowledge to complex medical problems and benefit/risk management.
  • Desire to stay current on the latest clinical information in your assigned therapeutic area.
  • Strong written and verbal communication skills.

AE Strategies has provided human capital management consulting to federal clients for over 20 years. We are proud to partner with the FDA to assist with their recruiting needs.



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