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FDA Product Specific Guidance and Research Fellowship

Oak Ridge Institute for Science and Education · Silver Spring, MD · 3 mo ago
ManagementFull-time

About the role

The FDA Office and Location: Research opportunities are available in the Office of Generic Drugs/Office of Research and Standards (ORS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.

Research Project

As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than drug products and corresponding regulations. This project explores knowledge management systems for FDA-funded scientific research, CDER approved drug products, CDER published guidance including product-specific guidance (PSG), as well as the refinement of processes and infrastructure to analyze and track how research outcomes from FDA-funded scientific research can be used to support PSG development. This project includes the development of knowledge management and research management tools to maintain, monitor, and analyze how the impact of outcomes from a scientific research program can be maximized to support future decision making.

Learning Objectives

You will gain insight into the FDA's Office of Generic Drugs, and how their research supports guidance development and regulatory decision making as part of the Generic Drug User Fee Amendments (GDUFA) Program. Under the guidance of a mentor, you will be trained on aspects of developing and implementing knowledge management and research management systems and will utilize these systems as tools to monitor and manage scientific research that supports product specific guidance development and regulatory decision-making. This training will provide experience on the process by which product specific guidance is developed and tracked, which will teach skills to enable successful career transition into science and research in a regulatory environment.

Mentor

The mentor for this opportunity is Jasdeep Floura (Jessie.Floura@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

March/April 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, 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.

Qualifications

  • Currently pursuing or have received a bachelor's, master's, or doctoral degree in one of the relevant fields.
  • Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree.
  • Discipline(s):
    • Business (1)
    • Chemistry and Materials Sciences (12)
    • Communications and Graphics Design (2)
    • Computer, Information, and Data Sciences (17)
    • Engineering (1)
    • Environmental and Marine Sciences (2)
    • Life Health and Medical Sciences (51)
    • Mathematics and Statistics (11)
    • Physics (16)
    • Science & Engineering-related (1)
    • Social and Behavioral Sciences (30)
  • I have lived in the United States for at least 36 out of the past 60 months.
  • I have read the FDA Ethics Requirements.

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