FDA Small Business and Industry Assistance Research Internship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Communications/Division of Drug Information (DDI), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
The DDI optimizes CDER’s educational and communication outreach efforts by engaging in effective internal and external interactions to provide timely, accurate, and useful information through traditional and social media channels. DDI engages in over 60,000 individual interactions in response to drug-related inquiries as well as managing major programs such as CDER Small Business and Industry Assistance (SBIA).
Under the guidance of the mentor the participant will perform research to assist CDER SBIA in enhancing its program by both utilizing metrics and evaluation methodologies to develop activity and outcome-level performance indicators. Throughout the course of this project, the participant will learn about the FDA drug regulatory process, the impact of CDER SBIA outreach initiatives, the metrics analysis and data mining necessary to influence programs and determine efficiency, the social media management to increase SBIA outreach, and will interact with and determine the regulatory needs of the pharmaceutical industry.
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 three 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, 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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org.