*Applications will be reviewed on a rolling-basis.
APPLY THROUGH EXTERNAL LINK. SUBMIT RESUME AND COVER LETTER WITH APPLICATION.
A research opportunity is available in the Office of New Drugs / Office of Drug Evaluation IV, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The reasons for waivers for otherwise required pediatric studies under the Pediatric Research Equity Act (PREA), when granted, are described in labeling when granted for reasons of safety (safety waivers) or expectation of lack of efficacy. While the Pediatric Review Committee (PeRC) commonly comments on labeling, each drug review division has final authority on specific labeling language. Understanding how such waivers are described in labeling and identifying variability across therapeutic areas will help inform potential best practices.
Under the guidance of a mentor, the participant will learn the mandated pediatric study requirements under the pediatric research equity act (PREA), gain an understanding of reasons for waiver (that is: any for cause exemption) for pediatric study requirements related to known safety issues with a drug, or expected lack of efficacy, gain hands-on experience leveraging publicly available (e.g., Drugs at FDA) and FDA proprietary (e.g., DARRTS) databases to provide data analysis for internal and external stakeholders via publication of results.
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 six 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, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
The qualified candidate should be currently pursuing or have received a bachelor’s, master’s or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0542) in your email.