*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of Pharmaceutical Quality (OPQ) / Office of Lifecycle Drug Products (OLDP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will identify and assess the current knowledge related to drug product quality, evaluate the current knowledge management approaches/methods, establish a modelized knowledge management framework to accommodate the drug product quality dashboard and its associated regulatory know-how, and build/populate the Quality Knowledge Management System (QKMS), using such a framework. OPQ OLDP recognizes that currently a great amount of regulatory knowledge has been accumulated during the review of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA). However, it is still a paramount challenge to easily share such knowledge to guide the assessment of other NDAs since such a knowledge base is dispersed and “hidden” in different parts of the Agency.
Under the guidance of a mentor, the participant will train on surveying the internal database to identify drug product quality information/knowledge is currently available; evaluate how the knowledge is being managed and conduct an in-depth gap analysis; and develop modelized frameworks to stratify and store the knowledge for future usage.
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 be currently pursuing or have received a master’s or doctoral degree in one of the relevant fields. 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-2020-0554) in your email.