*Applications will be reviewed on a rolling-basis.
A research opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality/ Office of New Drug Products (ONDP) located in Silver Spring, Maryland. CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
The project will facilitate streamlining the investigational new drug (IND) review and process, and will support development of an advanced IT system, Knowledge-aided Assessment and Structured Application (KASA) for IND, needed for ensuring regulatory assessment and knowledge management of INDs.
Under the guidance of a mentor, the participant will conduct data searches in reviews of commercial INDs, research INDs, treatment INDs, pIND meetings, and IND amendments to collect quality data to understand CMC clinical hold issues that would inform the development of a succinct and effective regulatory approach to IND assessment. The participant will learn about appropriate regulatory quality standards and quality risks control for drug products submitted in INDs. The participant will also learn about the pharmaceutical development process from regulatory perspective.
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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.