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This position is located in the Center for Drug Evaluation & Reserarch (CDER), Office of New Drugs (OND), Office of Antimicrobial Products (OAP), Divison of Antiviral Products (DAP) located at the White Oak Campus in Silver Spring, MD.
Who May Apply: Current OND employees only, with career or career conditional appointments in the competitive service;
YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE).
This announcement may be used to fill multiple positions in multiple locations.
Review and evaluate clinical study protocol and reports submitted in BLAs, NDAs, supplemental; new INDs, new protocols and protocol amendments.
Evaluate development plans and study protocols to determine the safety of designs and the ability to generate evidence of effectiveness.
Review and evaluate reports of clinical trials to determine if the data are adequate and well controlled, and sufficient to support the efficacy and safety of the drug under investigation.
Participate in coordinating initiatives and activities related to the program and the implementation of regulations and guidance.
Coordinate with other CDER offices on complex regulatory issues and keeps abreast of crucial and precedent-setting cases within agency.