FDA Generic Drug User Fee Amendments (GDUFA) Research Tracking Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Generic Drugs / Office of Research and Standards, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will research the proper evaluation and approval of generic drugs. The research will support projects for all therapeutic categories of generic drugs and will encompass projects from in vitro to in vivo studies. Results will support development of guidance's, recommendations to Industry, and regulatory review. The project will be focused on the following topic areas: (1) complex active ingredients, formulations or dosage forms, (2) complex routes of delivery, (3) complex drug-device combinations, and (4) tools and methodologies for bioequivalence and substitutability evaluation.
Under the guidance of a mentor, the participant will be trained in analysis and development of an existing web-based system utilized to maintain tracking and reporting of Generic Drug User Fee Amendments regulatory science projects. The participant will be involved with a range of software development, data management and automated report generation of data and activities related to research projects. This training is critical to our public health mission and will prepare the participant for a successful career transition into regulatory science research.
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.
Qualifications
The qualified candidate should be currently pursuing or have received a bachelor's degree in one of the relevant fields, with a focus on software engineering and a passion for producing quality software. 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-2020-0545) in your email.