FDA Research Fellowship - Characterizing Use

Position: FDA Research Fellowship - Characterizing Use of Real-World Evidence to Support
# FDA Research Fellowship
- Characterizing Use of Real-World Evidence to Support Oak Ridge Institute for Science and Education Be an Early Applicant Full Timemid Silver Spring, Maryland, USPosted Today##

Role Overview Oak Ridge Institute for Science and Education is hiring a mid-level FDA Research Fellowship
- Characterizing Use of Real-World Evidence to Support. This is a full-time role in Silver Spring. Part of Oak Ridge Institute for Science and Education's Mobile hiring, posted today. applications are still in the early window, before most candidates have applied. Full responsibilities, required qualifications, and the apply link are listed in the description below.## Salary Context Salary is not disclosed in this posting.

Market median for Mid-level Mobile roles is $70k-$90k (based on 37 comparable listings). Many employers share specifics during the interview process or after an initial screen.## Resume Keywords to Include Make sure these keywords appear in your resume to improve ATS scoring

GoSpringORBenefits Organization Food Drug Administration Sign  up free to auto-tailor your resume with all these keywords and get a higher ATS score##

Job Description

OrganizationU.S. Food and Drug Administration (FDA)
Reference CodeFDA-CDER-###

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 –  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.

Connect with ORISE...on the GO! Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!

Final date to receive applications8/28/2026 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.

Research Project:
You will join a project to conduct a systematic review of internal FDA approval documentation for new approvals, including clinical, epidemiological, and statistical reviews, advisory committee materials, and labeling. The project will extract key characteristics related to:
* Approval context and regulatory pathway;
* Intended versus actual use of real-world evidence (RWE) and rationale;
* Role of RWE in the evidence base (substantial evidence of effectiveness/confirmatory evidence/other);
* Real-world data (RWD) and RWE characteristics (data sources, study design, quality assessment, bias mitigation); and
* FDA review findings (strengths, limitations, feedback, labeling).With the support of relevant subject matter experts, you will learn to develop at least 10 training-ready case studies across therapeutic areas focused on the use of RWE in demonstrations of effectiveness for newly approved drugs and biologics. Through this project you will create a standardized case study template and an internal data repository to enable access to and dissemination of findings.

Learning Objectives:
Under the guidance of a mentor, you will have the following learning opportunities:
* Regulatory science landscape:
You will become familiar with the role of RWE in regulatory science, gaining exposure to priority research areas and emerging methodological developments that shape FDA's approach to RWE.
*…