FDA Public Health and Regulatory Research Fellowship

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Monthly stipend

Health insurance supplement

Job summary

U.S. Food and Drug Administration (FDA) is seeking a motivated participant for a 12-month full-time appointment in Silver Spring, MD. The program involves research across drug competition, regulatory pathways, and global health, with mentorship and an emphasis on policy-relevant publications.

The stipend is $7,600 per month, plus a health insurance supplement of $532 per month. Applicants must hold or be pursuing a master's or doctoral degree and be eligible for U.S. participation.

Qualifications

• Candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields.
• Degree should be anticipated to be received by 12/31/2026.
• Strong analytical and writing skills are required to contribute to policy-relevant publications.

Responsibilities

• Participate in research and analysis examining FDA drug approval programs, market dynamics, and access to medicines.
• Analyze data and regulatory frameworks; investigate market competition trends; engage with policy-relevant publications.
• Draft scientific papers and contribute to publications on global health topics in collaboration with mentors.

Skills

Quantitative research methods

Scientific writing

Team collaboration

Education

Master's or Doctoral degree in relevant fields

Degree anticipated by 12/31/2026

Job description

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

Reference Code: FDA-OC-2026-0003

Application Deadline: 11/27/2026 3:00:00 PM Eastern Time Zone

FDA Office and Location: Office of Commissioner (OC), Public Health Strategy and Analysis Staff (PHSA), located in Silver Spring, Maryland.

Description: Applications will be reviewed on a rolling basis.

Research Project

Project 1: Drug Competition and Access

You will participate in research and analysis examining FDA's drug approval programs, generic and biosimilar market dynamics, and the impact of regulatory pathways on drug availability and affordability for American consumers. Activities will include analyzing relevant data and regulatory frameworks, investigating market competition trends, and engaging with policy-relevant publications that can inform FDA priorities aimed at improving access to safe, effective, and affordable medicines.

Learning Objectives – Project 1

• Developing understanding of FDA drug approval programs, including generic and biosimilar pathways, and their role in medicine access and affordability.
• Building skills in analyzing regulatory, epidemiologic, and market data related to drug competition and availability.
• Understanding how regulatory science and policy considerations influence public health outcomes and patient access to safe and effective medicines.

Project 2: FDA Regulatory Pathways

You will investigate the design, utilization, and public health outcomes associated with FDA's regulatory pathways, including expedited programs and novel approval mechanisms. Activities will include analyzing data on pathway utilization, researching associated public health outcomes, and participating in findings that can inform policy development and Agency priorities.

Learning Objectives – Project 2

• Gaining knowledge of FDA regulatory pathways, including expedited programs and novel approval mechanisms, and their public health objectives.
• Strengthening analytical skills through evaluation of pathway utilization data and associated public health outcomes.
• Exploring how regulatory evidence and policy analysis contribute to Agency decision-making and public health priorities.

Project 3: Global Health

You will participate in research involving FDA's international public health mission. Activities will include analyzing global drug quality issues, investigating cross-border regulatory challenges, and researching partnerships aimed at strengthening international regulatory systems. You will also engage with mentors to research, draft, and contribute to scientific papers and policy-relevant publications on global health topics.

Learning Objectives – Project 3

• Developing understanding of FDA's role in global public health and international regulatory collaboration.
• Building skills in analyzing global drug quality issues, cross-border regulatory challenges, and international health data.
• Enhancing scientific communication abilities through research, drafting, and contribution to policy-relevant and scientific publications on global health topics.

Mentor: [e-mail]

Anticipated Appointment Start Date: November 1, 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length: The appointment will initially be for 12 months, 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. The anticipated stipend is $7,600 per month, plus $532 per month for a health insurance supplement.

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.

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.

Qualifications: The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree should be anticipated to be received by 12/31/2026.

Preferred Skills

• Experience in quantitative research methods, including but not limited to epidemiological analysis, secondary data analysis, or statistical modeling.
• Strong scientific writing skills and demonstrated ability to communicate complex findings to diverse audiences.
• Demonstrated ability to research both independently and collaboratively in a team environment.

Stipend: $7,600.00 Monthly

Point of Contact: Ashley

Eligibility Requirements

• Degree: Master's Degree or Doctoral Degree.
• Discipline(s):
  • Chemistry and Materials Sciences
    • Analytical Chemistry
    • Bio-inorganic Chemistry
    • Bio-organic Chemistry
    • Biophysical Chemistry
    • Chemistry (General)
    • Environmental Chemistry
    • Inorganic Chemistry
    • Materials Sciences
    • Organic Chemistry
    • Physical Chemistry
    • Polymer Chemistry
    • Theoretical Chemistry
  • Computer, Information, and Data Sciences
  • Environmental and Marine Sciences
  • Life Health and Medical Sciences
  • Social and Behavioral Sciences
• 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.)