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
• One educational or professional recommendation. Your application will be considered incomplete, and will not be reviewed until one recommendation is submitted.

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

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

*Although the application deadline is April 15th, mentors will start reviewing submitted applications before the deadline.

Summer research opportunities are available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). 

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. CDER's mission is to protect and promote health by helping to ensure that these human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients who need them.

Participants will have an opportunity to gain a hands-on research experience on a variety of regulatory research projects related to CDER's mission. The program is designed for participants to engage with an expert mentor or mentors during the summer to examine a question of interest related to those projects within the placement office. Past projects have been related to: drug metabolism, bio-statistical questions, in-vitro models for drug toxicology, safety and efficacy, benefit-risk assessments, etc. 

Both full-time and part-time appointments are typically available. Anticipated start day is on or around May 18, 2020, but can be negotiated with the mentor to commence on any Monday throughout the summer in order to best align with school and/or vacation schedules. 

To avoid conflict of interest, participants cannot be placed in the same CDER program office where a relative works.

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 2-3 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 part-time or full-time at FDA in the Silver Spring, Maryland or St. Louis, Missouri areas. 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.  OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

These opportunities are open to currently enrolled university students (all levels) and recent graduates who have graduated within the past 60 months of the start date. Demonstrated excellence in science-related courses is preferred.

• Degree: Associate's Degree, Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or currently pursuing.
• Discipline(s):
  • Chemistry and Materials Sciences (7 )
  • Communications and Graphics Design (2 )
  • Computer, Information, and Data Sciences (16 )
  • Engineering (12 )
  • Environmental and Marine Sciences (3 )
  • Life Health and Medical Sciences (45 )
  • Mathematics and Statistics (10 )
  • Other Non-Science & Engineering (2 )
  • Physics (3 )
  • Science & Engineering-related (1 )
  • Social and Behavioral Sciences (10 )