*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) located at the Office of Regulatory Affairs (ORA) Pacific Southwest Medical Products Laboratory in Irvine, California.
The Office of Generic Drugs (OGD) makes high quality, affordable medicines available to the public and is the world leader in the science and regulation of generic medicines. Therefore, scientific research is needed for the proper evaluation and approval of generic drugs. This project will support projects for all therapeutic categories of generic drugs and will encompass projects from in vitro to in vivo animal and clinical studies as well as predictive data from modeling tools. 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, (4) tools and methodologies for bioequivalence and substitutability evaluation. Results will support development of guidance, recommendations to Industry, and regulatory review, supporting development of scientific regulatory policy.
Under the guidance of a mentor the participant will be trained on conducting microbial testing on marketed ophthalmic products to evaluate the usefulness of the microbial test for determining bioequivalence. The participant will learn how to prepare reports and data analysis on test results to support regulatory decision making.
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 Irvine, California, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
The Homeland Security Presidential Directive-12 (HSPD-12) mandates a background check be completed for both U.S. Citizens and foreign nationals. Foreign nationals must have resided in the U.S. for at least three (3) of the past five (5) years in order for FDA to be able to complete a background check.
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.
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