FDA Product Specific Guidance and Research Fellowship

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 33,480 - 55,800; Full time

Job summary

A federal agency in Silver Spring, Maryland, is offering a full-time fellowship for individuals pursuing or having received a relevant degree. This program aims to enhance knowledge management systems for FDA-related scientific research. Applicants must possess analytical skills and a strong grasp of regulatory processes. The fellowship offers a flexible start date in March/April 2026, a renewable one-year term, and a stipend based on education and experience.

Qualifications

• Currently pursuing or have received a relevant degree.
• Strong understanding of FDA's Generic Drug program.
• Experience with knowledge management systems.

Responsibilities

• Develop knowledge management systems for FDA-funded research.
• Analyze scientific outcomes for regulatory decision-making.
• Contribute to guidance development for drug products.

Skills

Knowledge management systems

Regulatory processes

Project Management

Communication skills

Data analysis

Education

Bachelor's, Master's, or Doctoral degree in a relevant field

Job description

Program Overview

The ORISE 2026-0014 Fellowship is offered by the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryland. The fellowship supports research related to FDA’s Office of Generic Drugs and the Center for Drug Evaluation and Research (CDER).

Project Description

Applicants will work on knowledge management systems for FDA‑funded scientific research, CDER approved drug products, and product‑specific guidance. The research will develop tools to monitor, analyze, and maximize the impact of scientific outcomes on guidance development and regulatory decision making.

Learning Objectives

Participants will gain insight into the FDA’s Generic Drug program, learn to develop and implement knowledge management systems, and acquire experience in guidance development and regulatory processes.

Mentor

Jasdeep Floura ([e-mail]). For questions about the project, contact the mentor.

Appointment Details

• Start Date: March/April 2026 (flexible)
• Length: One year, renewable upon recommendation and funding availability
• Participation: Full time
• Stipend: Monthly stipend commensurate with educational level and experience

Citizenship and Background Requirements

• Open to U.S. citizens, lawful permanent residents, and eligible foreign nationals.
• Applicants must complete a background investigation by the Office of Personnel Management. OPM will investigate only individuals who have resided in the U.S. for at least three of the past five years.
• Proof of health insurance is required.

Eligibility Requirements

• Degree: Bachelor’s, Master’s, or Doctoral degree in a relevant field.
• Discipline(s) accepted:
• Business – Project Management
• Chemistry and Materials Sciences
• Communications and Graphics Design
• Computer, Information, and Data Sciences
• Engineering
• Environmental and Marine Sciences
• Life Health and Medical Sciences
• Mathematics and Statistics
• Physics
• Science & Engineering‑related
• Social and Behavioral Sciences
• Affirmation: I have lived in the United States for at least 36 of the past 60 months.
  I have read the FDA Ethics Requirements.

Qualifications

The qualified candidate should be currently pursuing or have received a bachelor’s, master’s, or doctoral degree in one of the relevant fields listed above.