FDA Postdoctoral Fellowship: Infrastructure and Methods Development Sustainable

Organization
U.S. Food and Drug Administration (FDA)

Reference Code
FDA-CDER-

To submit your application, scroll to the bottom of this opportunity and click APPLY.

A Complete Application Consists Of

• An application
• Transcripts –  for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER. Please include the reference code for this opportunity in your email.

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7/31/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling-basis.

The FDA Office and

Location:

A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at Silver Spring, Maryland. CDER performs essential public health tasks to ensure safe and effective drugs are available to the public. This includes regulation of over-the-counter and prescription drugs, biological therapeutics, and generic drugs.

Research Project
:
This fellowship will offer the opportunity to participate in the following project goals:

• Help the RWE Analytics Team in developing and validating optimized workflows and analytical methods to improve efficiency, consistency, and scalability of RWE submission monitoring and public reporting.
• Contribute to creation of comprehensive technical documentation and standard operating procedures to support program continuity and knowledge transfer.
• Help with longitudinal analysis of RWE monitoring data (FY ) to identify trends and inform future regulatory science initiatives.

Learning Objectives
:
Upon completion of this fellowship, you will be able to:

• Apply regulatory science principles and FDA evaluation frameworks to assess the quality, reliability, and regulatory utility of real-world evidence submissions in support of drug approval and post marketing requirements.
• Design and implement health informatics workflows and data management systems to support systematic monitoring, capture, and analysis of regulatory submissions containing real-world data from diverse sources.
• Evaluate methodological approaches used in real-world evidence studies across different regulatory contexts, including externally controlled trials, observational studies, and post marketing safety surveillance, and communicate findings to regulatory and scientific audiences.

Mentor
:
The mentor for this opportunity is Joel Weissfeld (joel.weissfeld.gov).

Start date is flexible and will depend on a variety of factors.

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.

Participant Stipend
:
The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements
:
This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

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 onboarding  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…