FDA Fellowship in Program, Policy and Operational Analysis

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available in the Office of Strategic Programs (OSP) / Office of Program & Strategic Analysis (OPSA), 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.

Research Project: This project will support and analyze a broad range of proposed and current CDER programs and policies by conducting quantitative and qualitative analyses to address operational needs. OPSA assesses the impact and efficiency of CDER initiatives and programs, designs and implements new programs, advances structured benefit-risk assessment in regulatory decision making and evaluates key business processes using evidence-based approaches that assess the value of each step and leads to sustained practical solutions for complex problems. OPSA's work informs and influences organizational strategy and decision-making by senior management and serves as key input into decision-making around the related program, policy or operational issue.

Learning Objectives: Under the guidance of a mentor, the participant will learn to: conduct background research related to a policy or data need identified by the mentor, participate in the development of research methodology and project planning through contributing to relevant research, compile and analyze relevant qualitative and quantitative data, and synthesize and present findings. This project is critical to our public health mission and the training will prepare the participant for a successful career transition into regulatory science research.

Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation: The appointment is full-time or part-time.

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the valid immigration statuses that are acceptable for program participation.

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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA.  OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists . 

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.