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This Interdisciplinary Scientist position will be filled under one of the following disciplines:
Biologist (0401); Microbiologist (0403); or Chemist (1320).
This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigations (OSI). The incumbent will be responsible for serving as the subject matter expert in addressing and solving unusual and often precedent setting problems associated with the regulatory compliance segments of office activities.
This job opportunity announcement may be used to fill additional vacancies.
- Develops policies and programs involving complex scientific matters impacting public health and/or the regulation of drugs.
- Reviews, edits, and approves program compliance documents such as procedures, guidelines, policies, and technical papers.
- Advises on regulatory actions such as, international agreements, and post-market surveillance, case management, guidance and policy development, and inspections.
- Plans projects related to drug trials or post marketing safety issues.
- Negotiates with industry and other external stakeholders and makes recommendations regarding regulated actions.