A complete application consists of:      

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• Two educational or professional references

All documents must be in English or include an official English translation.

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

A research opportunity is available at the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD).

FDA's Office of Generic Drugs (OGD) is committed to conducting regulatory science research related to generic drugs under the Generic Drugs User Fee Agreement of 2012 (GDUFA). This program is an opportunity in which participants will engage with a mentor or mentors in the Office of Generic Drugs during a targeted internship to examine a question of interest to the office. The interns will collaberate on research projects on topics relevant to OGD science needs. Interns will gain hands-on regulatory research experience under expert OGD mentors on a variety of projects to address these five priority areas: Post-market Evaluation of Generic Drugs, Equivalence of Complex Products, Equivalence of Locally Acting Products, Therapeutic Equivalence Evaluation and Standards and Computational and Analytical Tools.

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 initial appointment is for up to 12 months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, MD area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.

Applicants must be currently enrolled in a bachelors, masters, or doctoral program or have received one of these degrees within five years of the desired starting date.

• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 month(s).
• Discipline(s):
  • Chemistry and Materials Sciences (12 )
  • Engineering (27 )
  • Environmental and Marine Sciences (1 )
  • Life Health and Medical Sciences (45 )