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This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Drug Evaluation 3 (ODE). The incumbent serves on a multi-disciplinary scientific/medical team that reviews, evaluates and decides on the approvability of drug submissions and applications that request regulatory consideration.
This job opportunity announcement may be used to fill additional vacancies.
- Reviews and evaluates scientific submissions (e.g., non-clinical pharmacological and toxicological studies) to determine the toxicological potential of drugs.
- Prepares comprehensive summaries of data submitted including regulatory recommendations for concurrence by the supervisor.
- Applies new developments and theories to critical and novel problems regarding pharmacological/toxicological issues.
- Provides leadership and regulatory guidance to subordinate pharmacologist.
- Meets with industry representatives to exchange information and provide advice in support of clinical studies, New Drug Applications (NDA), or Biologic License Applications (BLA), and deficiencies in animal studies.