FDA NLP Consumer Data Review Fellowship

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 33,000 - 45,000; Full time

Benefits offered by this job

Stipend

Mentor support

Job summary

A research opportunity is available immediately with the FDA in Silver Spring, Maryland, hosted by the Oak Ridge Institute for Science and Education (ORISE). Fellows will join a community of scientists applying NLP to automate FDA’s review of qualitative consumer study responses.

The program emphasizes learning objectives from consumer studies, data structures, NLP concepts, and evaluating model performance, with a mentorship from Yong Ma. Eligibility includes U.S.

Qualifications

• Master's or Doctoral degree in a relevant field.

Responsibilities

• Describe how consumer studies support OTC drug approval.
• Explain challenges from large verbatim data in regulatory review.
• Identify structure and content of typical consumer study datasets.
• Define NLP concepts: tokenization, text classification, named entity recognition.
• Compare rule-base and ML approaches for regulatory use.
• Apply NLP tools to process and classify qualitative responses.
• Evaluate NLP model performance and interpret results for FDA reviews.

Education

Master's or Doctoral degree in relevant field

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0147

Application Deadline

11/6/2026 3:50:13 PM Eastern Time Zone

Description

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

• 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 ([e-mail]). 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.

Education

• 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.

Point of Contact

Ashley

Eligibility Requirements

• Citizenship: LPR or U.S. Citizen
• Degree: Master's Degree or Doctoral Degree.
• Discipline(s):
  • Computer, Information, and Data Sciences (Artificial Intelligence (including Robotics, Computer Vision, Human Language Processing, and Machine Learning))
  • Computer Architecture and Grids
  • Computer Science - Languages and Systems
  • Computer Science - Theoretical Foundations
  • Computer Science (general)
  • Computer Systems Analysis
  • Computer Systems Design (including Signal Processing)
  • Data Science
  • Databases, Information Retrieval, and Web Search
  • Graphics and Visualization
  • Human Computer Interaction
  • Information Science and Technology
  • Information Security and Assurance
  • Networks and Communications
  • Operating Systems and Middleware
  • Scientific Computing and Informatics
  • Software Engineering
• Mathematics and Statistics (11 )

Affirmation

I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

and

I have read the FDA Ethics Requirements.