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This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs(OGD). The incumbent will serve as project manager and be responsible for planning, focusing, and coordinating team activities within the assigned division.
This announcement is opened continuously for 90 days. Applications received by the first cut-off date will receive first consideration.
1st Cut-off date: 5/29/2014
2nd Cut-off date: 6/19/2014
3rd cut-off date: 7/11/2014
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-14-MP-1070893KC 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.
- Serve as co-leader managing activities collaborating with the scientific co-leaders on assigned project(s).
- Manage entire review process, including internal and external meetings, for one or more classes of drugs to ensure regulatory and policy requirements are being met.
- Develop project plans to include setting time frames, milestones, and agreed upon completion dates.
- Ensure the timely resolution of scientific and regulatory conflicts or problems to maintain project and performance goals.
- Monitor the workload for the specific drug application review team.
- Report project activities and status for assigned projects.