*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Surveillance and Epidemiology/ Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.

The 21st Century Cures Act is designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them. Under this Act, FDA must evaluate the use of real-world evidence (RWE) to support regulatory decision making, including approval of new indications for approved drugs or to support or satisfy postapproval study requirements. FDA initiated a RWE Program to address key issues in the use of RWE for regulatory purposes. This project aims to describe the nature of the RWE submissions, summarize recommendations, and analyze the lessons learned in regulatory implications, which would inform future RWE reviews and regulatory decision making.

Under the guidance of a mentor the participant will gain skills in quantitative and qualitative analyses of RWE submissions. In addition, the participant will gain knowledge in regulatory science, clinical trials and pharmacoepidemiology research, and real world evidence use for regulatory decision making.

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 one year, 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 can be full-time or part-time (20 hours per week) 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.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0606) in your email.