FDA Fellowship - Applying Large Language Models (LLM) in Drug Safety Reviews

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0100

How To Apply

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

A Complete Application Consists Of

• An application
• Transcripts – Click here 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.

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

Application Deadline

8/14/2026 3:00:00 PM Eastern Time Zone

Description

• Applications will be reviewed on a rolling-basis.
  
  

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.

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. These efforts cover more than just medicines.

Research Project: This project is in the Office of Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and Epidemiology (OSE). Our Office uses literature reviews to synthesize evidence from published literature to support regulatory decision-making. This ongoing project evaluates the large language model (LLM) performance for selected literature review tasks, including abstract and title screening, and information extraction. In joining this project, you will:

• Expand LLM benchmark datasets using FDA reviewers' literature reviews.
• Learn to develop prompts and design benchmark and validation studies to assess performance in additional literature review tasks.
• Research multi-step processes and agentic models, including comparisons with single-step chatbot models and their respective evaluation methodologies.
  
  

Learning Objectives: Guided by multidisciplinary mentors and collaborators with expertise in regulatory science, AI, clinical practice, pharmacoepidemiology, and pharmacovigilance, you will gain in-depth knowledge of evaluating and applying LLMs in literature reviews in drug safety evaluation. This unique opportunity provides firsthand experience with LLMs for enhanced drug safety review and exposure to drug safety practices in regulatory settings.

Mentor: The mentor for this opportunity is Hui Lee Wong (Huilee.Wong@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: June 30, 2026. 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.

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.

Education

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.
  
  

Qualifications

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields. Degree must have been received within the past five years, or to be received by August 31, 2026.

Preferred Skills

• Profound knowledge of epidemiological principles and hands-on experience of medical literature review is highly desirable.
• General knowledge about LLMs and prompt design is preferred.
• Knowledge about the architecture of LLMs and experience of running LLMs in a local environment or through an API is a plus.
  
  

Point of Contact

Ashley

Eligibility Requirements">6 )

• Degree: Master's Degree or Doctoral Degree received within the last 60 months or anticipated to be received by 8/31/2026 12:00:00 AM.
• Discipline(s):
• Computer, Information, and Data Sciences ( Show more