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You will serve as a Safety Regulatory Health Project Manager for all post-marketing studies and clinical trials for the Office of New Drugs, Center for Drug Evaluation and Research.
This job opportunity announcement may be used to fill additional vacancies.
- Provide expertise on all areas of drug regulation, regulatory policy and postmarketing safety activities.
- Write technical correspondence related to drug safety issues.
- Collaborate with regulatory project managers and scientific reviewers, consumer and health care professionals, advocacy groups, academia officials, professional societies, Congress, etc.
- Managing, tracking and coordinating postmarketing safety activities.
- Identifies, assesses, and resolves emerging complex safety issues.