REGULATORY HEALTH PROJECT MANAGER, GS-601-12/13
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This position is located in the Division of Epidemiology, Office of Biostatistics and Epidemiology, (OBE), Center for Biologics Evaluation and Research (CBER), Silver Spring, Maryland.
This vacancy is also being announced concurrently with vacancy announcement FDA-CBER-17-MP-1972881AS 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.
Who May Apply: Open to all United States Citizens.
Additional selections may be made within the same geographical area FDA-wide.
- Not Required
In order to qualify for Regulatory Health Project Manager, GS-601-12, you must meet the following:
Degree: Major study in an academic field related to health sciences or allied sciences appropriate to the work of the position.
Have one year of specialized experience, equivalent to the GS-11 in the Federal service, performing quality assurance checks on scientific or regulatory data, and track and manage data in regulatory and scientific data management information systems; initiating written correspondence in response to regulatory or scientific inquiries; and drafting regulatory or scientific policies and procedures.
Conditions of Employment:
- Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
- E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
- Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
- Pre-employment physical required: No
- Drug testing required: No
- License required: No
- Mobility agreement required: No
- Immunization required: No
- Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
- Bargaining Unit Position: Yes
- All qualification requirements must be met by the closing of the announcement.
- Financial disclosure statement required: No
Public Trust - Background Investigation
- Serve as the primary focal point for coordinating and processing progress reports and information requests.
- Manage and coordinate the work of the review team members for the specific drug application review to determine how much progress is being made and if any problems are surfacing.
- Identify project activities or situations that may adversely impact project plan and advising supervisors, team members and management of potential impact.
- Initiate correspondence regarding action, policy issues or requests for additional information.
- Serve as the primary point of contact for the up to date status of project progress and representing the team activities to management.
- Provide advice and counsel to all parties engaged or interested in FDA biologic review process concerning assigned biologic classes.
- Assure timely completion of project activities relating to assigned biologic groups and applications and attain project objectivities within established project plans and performance goals set by the team.