TRI
Published
September 15, 2021
Location
Bethesda, MD
Job Type
Work Setting
In-office

Description

Responsibilities

  • Prepares scientific and regulatory documents on behalf of government and private sector clients for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and investigator’s brochures)
  • Performs literature searches and/or prepares summaries of results
  • Prepares meeting reports and proceedings, safety documents or data analysis
  • Contributes to technical proposals and responds to technical questions
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