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This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Biologics Evaluation and Research (CBER), in Silver Spring, MD.

Responsibilities

  • Serves as a Senior Clinical Analyst on a multi-disciplinary team of health care professionals that includes physicians, pharmacologists, biologists, chemists, and biostatisticians.
  • Responsible for reaching regulatory decisions and recommending approval of safe and effective human drugs and biologics in a timely manner. Display a thorough understanding of complex policies and regulations.
  • Collaborate with other clinicians and industry officials to ensure that scientific issues related to a drug development are fully addressed in a fair and equitable manner.
  • Provides expert clinical analysis and advice on complex issues as well as collects relevant data from many varied sources, some of which are difficult to access.