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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 Drug (OND). The incumbent will serve as the project coordinator/manager for a drug review team consisting of both scientific and regulatory personnel within and outside the division.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-937113 under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
This job opportunity announcement may be used to fill additional vacancies.
- Serves as co-leader managing activities collaborating with the scientific co-leaders on assigned project(s).
- Manages entire review process, including internal and external meetings, for one or more classes of drugs to ensure regulatory and policy requirements are being met.
- Develops project plans to include setting time frames, milestones, and agreed upon completion dates.
- Ensures the timely resolution of scientific and regulatory conflicts or problems to maintain project and performance goals.
- Monitors the workload for the specific drug application review team.
- Reports project activities and status for assigned projects.