FDA NLP Consumer Data Review Fellowship

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), 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: Consumer studies, essential to OTC drug approval, usually enroll several hundred participants, with each participant answering more than a dozen study questions, resulting in large volumes of verbatim data. As an Oak Ridge Institute for Science and Education (ORISE) participant, you will join and learn from a community of scientists and researchers engaged in an effort to use natural language processing (NLP) to automate FDA’s review of these qualitative responses, potentially providing both more accurate and efficient review of consumer data.

Learning Objectives: Under the guidance of a mentor, you will learn how to:

• Describe the role of consumer studies in the FDA's OTC drug approval process and explain why large volumes of verbatim data present challenges for regulatory review.
• Identify the structure and content of typical consumer study datasets, including the types of questions asked and the nature of participant responses.
• Define core NLP concepts relevant to text analysis, such as tokenization, text classification, and named entity recognition.
• Compare traditional rule-based NLP approaches with modern machine learning-based approaches and articulate when each may be appropriate in a regulatory context.
• Apply NLP tools and frameworks to process, analyze, and classify qualitative consumer study responses.
• Evaluate NLP model performance using appropriate metrics and interpret results in the context of regulatory review requirements.
• Identify potential sources of bias and error in NLP-assisted review and articulate strategies for mitigating them.

Mentor: The mentor for this opportunity is Yong Ma (yong.ma@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: December 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.

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 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.