*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Surveillance and Epidemiology- Immediate Office, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will improve evidence-based regulatory decisions, aimed to evaluate the impact of FDA’s regulatory activities, which may include labeling changes, Risk Evaluation and Mitigation Strategies (REMS), or Drug Safety Communication (DSC).
Under the guidance of a mentor, the participant will learn how to handle and use the real-world data (RWD) such as patient-level longitudinal data or large cross-sectional data sets. In addition, the participant will also learn how to design and propose a regulatory research; then conduct and summarize the study 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 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 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 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-2020-0562) in your email.