Physician Reviewer

4 days ago


Silver Spring, Maryland, United States AE Strategies Full time
Job Summary

We are seeking a highly skilled Physician Reviewer to join our team at the FDA. As a key member of our Division of Anesthesiology, Addiction Medicine, and Pain Medicine, you will play a critical role in reviewing Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs) for prescription drugs and biologics intended for the prevention, treatment, or diagnosis of conditions including acute and chronic pain, addiction, and anesthesia.

Responsibilities
  • Review and evaluate clinical trial results and labeling accuracy to ensure the drug works as intended and has clear instructions and warnings.
  • Analyze summaries from other experts and recommend approving, requesting more data, or rejecting applications.
  • Consult with other specialists to address complex issues and stay up to date on scientific advancements.
  • Share expertise through conferences and publications.
Requirements
  • US or Canadian Medical Degree: MD, DO, or equivalent from an accredited school.
  • Foreign Medical Degree: MD or equivalency, such as a ECFMG certification or USMLE completion.
  • Current, active, full, and unrestricted medical license in the US or its territories.
Preferred Qualifications
  • Ability to apply clinical and scientific knowledge to complex medical problems and benefit/risk management.
  • Enjoys solving unique problems and addressing challenges in drug/biologic regulatory review.
  • Desire to stay current on the latest clinical information in your assigned therapeutic area.
  • Capable of strong written and verbal communication.


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