FDA Risk-Based Assessment & Inspections Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Strategic Programs/ Office of Business Informatics, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
This project seeks to contribute to detailed analysis and data profiling of pre- and post-market drug products, ingredients and facility data. We will examine quality measures and confidence levels using advanced analytics and visualization tools to contribute to the development and refinement of decision science tools / decision support systems.
Under the guidance of a mentor, the participant will learn data modeling, big data analysis, and quality assurance principles on data utilized by the scientific community. The participant will have an opportunity to attend various internal meetings to learn from an established federal specialist, leadership and other stakeholders.
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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.