A complete application consists of:
All documents must be in English or include an official English translation.
If you have questions, send an email to FDArpp@orau.org. Please include the reference code for this opportunity in your email.
A research opportunity is available in the Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Office of Generic Drugs (OGD) coordinates and manages the generic product review process, provides safety, surveillance, clinical, and bioequivalence reviews for generic products, as well as develops policy and regulatory science research to assist in evaluation of generic drugs and their approval. To lead these regulatory science commitments, Office of Research and Standards (ORS) was formed in 2014. The Division of Therapeutic Performance (DTP), one of the two divisions within ORS, consists of subject matter experts with diverse backgrounds who conduct and promote regulatory science research to establish standards in order to ensure therapeutic equivalence of generic versions of drug products. The division also facilitates pre-ANDA development of generic drugs, using various tools such as product specific recommendations, guidance development, and direct communications with generic sponsors, such as through controlled correspondences, and pre-ANDA meeting requests.
This position at DTP will provide the participant with the opportunity to acquire keen understanding of regulatory science that supports the development of therapeutic equivalence assessment standards. This fellowship will offer early career scientists unique opportunities to broaden their regulatory science knowledge by working with experienced scientific reviewers within DTP and across other offices at CDER, and with extramural collaborators.
The participants may engage in the following activities:
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for 12 months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, MD area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
A doctoral, medical, PharmD, or other qualified scientists holding advanced degree(s) in Clinical Pharmacology, Pharmaceutical Sciences, Chemistry, or Engineering received within the last 5 years.