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Clinical Review Physician at FDA

2 months ago


Silver Spring, Maryland, United States AE Strategies Full time

Responsibilities of Medical Officers at AE Strategies include:

  • Verifying that all pharmaceuticals produced for interstate commerce are both safe and effective, accompanied by accurate and informative labeling.
  • Ensuring the safety, efficacy, and quality of vaccines, blood products, certain diagnostic tools, and other biological and biotechnology-derived human products.
  • Overseeing the safety and functionality of medical devices while minimizing unnecessary human exposure to artificial radiation from medical, occupational, and consumer products.
  • Conducting thorough inspections and investigations of food and drug manufacturing facilities, performing analytical evaluations, and recommending necessary enforcement actions.

Salary Grade Levels

The typical federal General Schedule (GS) grade levels for these roles are GS-14 and GS-15. Non-supervisory roles will undergo peer review of individual achievements.

Required Qualifications

A Doctor of Medicine or Doctor of Osteopathy degree from an accredited institution in the United States or Canada; OR a Doctor of Medicine or equivalent degree from an international medical school that offers education and medical knowledge comparable to accredited U.S. institutions. This equivalency may be demonstrated through permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG) or a fifth pathway certificate for American students who completed premedical education in the U.S. and graduate education abroad.

  • For GS-14 - A minimum of four years of residency training in the relevant specialty or equivalent experience and training.
  • For GS-15 - A minimum of five years of residency training in the relevant specialty or equivalent experience and training. (Residency programs involve specialized training in accredited institutions recognized by the American Medical Association).

Work Locations

Medical Officers are positioned in various locations, including headquarters and field offices.