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

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.

*Applications will be reviewed on a rolling-basis.

An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), in the Office of Surveillance and Epidemiology / Office of Medication Error Prevention and Risk Management located in Silver Spring, Maryland.

The Network for Excellence in Health Innovation estimates that outpatient and inpatient preventable medication errors have an annual cost of nearly $21 billion. This project aims to enhance FDA’s pharmacovigilance program to identify and prevent errors associated with CDER-regulated products. Under the guidance of a mentor, the participant will research regulatory approaches to address medication error-related issues associated with drug products. Through this research, the participant will gain experience understanding the causes of medication errors, and learn to identify how medication errors play a role in drug nomenclature, packaging, labels and labeling, and the role of human factors in addressing these errors. 

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 one year, 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, Maryland, area. 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.

The qualified candidate should be currently pursuing or have received a bachelor's, master's, or doctoral degree (including Doctor of Pharmacy [PharmD]) in one of the relevant fields. Degree must have been received within five years of the appointment start date.

Preferred skills:

• Demonstrated strong medication safety and analytical experience

• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or currently pursuing.
• Discipline(s):
  • Computer, Information, and Data Sciences (17 )
  • Life Health and Medical Sciences (45 )

Have you lived in the United States for at least 36 out of the past 60 months? (36 months do not have to be consecutive.)