*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs/Office of Nonprescription Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
In 1972, The FDA initiated an Over the Counter (OTC) drug monograph review process to evaluate the safety and effectiveness of thousands of marketed OTC products. An OTC drug monograph serves as a kind of “rule book” for regulated industry in formulating OTC products by specifying “conditions of use” under which a given category of products are considered to be Generally Recognized as Safe and Effective (GRASE) and not misbranded. This review process is ongoing to modify and update the monographs to keep pace with changing science. The literature search results and related analyses of publicly available information will be used by the Office of New Drugs / Office of Nonprescription Drugs as background data for monograph reviews in support of FDA actions related to the OTC Drug Monographs.
Under the guidance of a mentor the participant will train on conducting comprehensive literature search on specific monograph drug active ingredients or other monograph condition; summarizing and analyzing relevant data from the literature search; and summarizing and analyzing key findings, limitations, and data gaps from white papers and published data submitted to the public docket.
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.
The qualified candidate should have received a doctoral degree in one of the relevant fields, or be currently pursuing the degree and will reach completion by May 1, 2021. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0558) in your email.