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As a Regulatory Health Project Manager in the Division of Epidemiology, Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER), you will serve as project manager for a number of the division's review teams and is responsible for the planning, focusing, and coordinating of the teams' activities within the division.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CBER-DE-13-960460 under competitive procedures. Please review that announcement to see if you are eligible for consideration under competitive procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement under noncompetitive merit promotion procedures. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
This job opportunity announcement may be used to fill additional vacancies.
- Manages the biologic review process for multiple biologics.
- Ensures compliance with all legal, regulatory, and policy requirements in assigned biologic classes.
- Facilitates the timely completion of project activities and attainment of project objectives within established project plans.
- Coordinates the resolution of conflicting resource needs, availability and scheduling.
- Serves as primary contact for all communications concerning applications for biologic classes.
- Collaborates with scientific, regulatory, and management team members to develop project plans.