Physician Clinical Reviewer Pulmonologist Critical Care

5 days ago


Silver Spring, Maryland, United States AE Strategies Full time
About the Role

The Clinical Trial Reviewer is a full-time physician position with the FDA, requiring a strong foundation in clinical and scientific knowledge. As a hybrid role, candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and be willing to report to the office at least one day per week.

A Day in the Life

As an infectious disease expert for the FDA, you will review new drugs to ensure they are safe and effective. Your responsibilities will include evaluating clinical trial results, labeling accuracy, and potential new uses or label changes. You will work with your team to make evidence-based decisions, analyze summaries from other experts, and recommend approving, requesting more data, or rejecting applications.

Key Responsibilities
  • Evaluate clinical trial results and labeling accuracy to ensure the drug works as intended and has clear instructions and warnings.
  • Review updates, safety reports, and potential new uses or label changes for existing drugs.
  • Work with your team to make evidence-based decisions and analyze summaries from other experts.
  • Recommend approving, requesting more data, or rejecting applications based on your expertise.
  • Consult with other specialists to address complex issues and stay up to date on scientific advancements.
  • Share your expertise through conferences and publications.
Requirements

To be successful in this role, you will need:

  • A US or Canadian Medical Degree (MD, DO, or equivalent) from an accredited school.
  • A Foreign Medical Degree (MD or equivalency) with ECFMG certification or USMLE completion.
  • A current, active, full, and unrestricted medical license in the US or its territories.
  • 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.
  • Capable of strong written and verbal communication.


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