FDA Fellowship - Orange Book NDA and ANDA Parenteral Combination Drug Product

About the role

The FDA Fellowship focuses on examining approved letters and product labeling to ensure accurate information for product listings on the Orange Book website. It also involves researching and confirming Reference Listed Drug (RLD), Reference Standard (RS), Therapeutic Equivalence (TE) codes, and approval date information.

Responsibilities

• Learn the structure and purpose of approved letters and product labeling in supporting regulatory documentation and public listings.
• Verify and ensure accurate capture of product listing information for the Orange Book website.
• Research and confirm RLD, RS, TE codes, and approval date information.
• Cross-reference regulatory documents and databases to ensure consistency and accuracy in publicly available records.
• Understand the importance of accurate drug listing information in promoting transparency, generic drug development, and regulatory decision-making.
• Gain knowledge of various aspects of the Orange Book publication information to support miscellaneous projects as directed by the mentor or other designated staff members.

Requirements

• A master's or doctoral degree in a relevant field, received within the last 5 years or currently pursuing.
• Citizenship: U.S. Citizen Only.
• Experience in life health and medical sciences preferred.

Qualifications

• Master's received, or pursuing to receive by June 2026.
• Doctoral received, or pursuing to receive by June 2027.

Skills

• Strong analytical skills.
• Excellent attention to detail.
• Proficiency in Microsoft Office.

Benefits

Participants will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program.

Pay

The participant will receive a monthly stipend commensurate with educational level and experience.

Schedule

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Contact Information

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

Connect with ORISE

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!

Anticipated Appointment Start Date

2026. Start date is flexible and will depend on a variety of factors.

Additional Information

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.

Background Investigation

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.

ORISE Ethics

The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!