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As a Supervisory Medical Officer within the Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), you will serve as the Division Director in planning, managing, coordinating, and evaluating the clinical review and safety/surveillance activities of the Division.
*This announcement is open to current CDER employees serving in a career or career-conditional appointment.
This job opportunity announcement may be used to fill additional vacancies.
- Provides technical expertise on clinical issues related to generic drug products.
- Conducts bioequivalence studies with clinical endpoints, safety assessments during bioequivalence trials and surveillance of safety aspects of currently approved generic products.
- Conducts secondary review and evaluations of abbreviated new drug applications (ANDAS), consultations, study protocols, and controlled correspondences.
- Provides leadership and direction in strengthening the clinical review component that defines the safety of generic drug products during the pre- and post-approval process.
- Collaborates in interdisciplinary team settings to discuss issues related to products under review and to provide authoritative advice on difficult or high priority decisions.