This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), in White Oak, MD.Learn more about this agency
Note: Salary figures shown represent the OPM General Schedule Base Salary. Candidates may be eligible to receive Title 38 Physician and Dentist Pay (PDP), in addition to the regular General Schedule base salary.
- The incumbent will serves as a source of continuity following marketing approval and regularly review the adequacy of labeling.
- Provides secondary reviews (and infrequently primary reviews) of the results of studies or other information to determine the adequacy of clinical post- marketing requirements and commitments.
- Evaluates the proposed trial(s) to determine the risks and its potential benefits. She/He Identifies and analyzes areas in need of new policy formation
- Reviews the design of the protocol(s) for its ability to test the clinical hypothesis established for the study; and to produce data that is useful to determine its safety and effectiveness.
- Consults with colleagues, other scientists, advisory committees, etc., regarding regulatory activities or other projects.
- The incumbent will serve as a principal advisor of information on matters related to the development of new regulations and guidance documents pertinent to cell and gene therapy, plasma protein therapeutics and other regulated medical products.
- Leads, reviews, and evaluates work to subordinates on a regulatory, scientific and clinical matters.
25% or less - You may be expected to travel for this position.
Job family (Series)
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/603157500. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.