*Applications will be reviewed on a rolling-basis.

The Center for Drug Evaluation and Research (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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than just medicines.

This project is located in the Office of Generic Drugs (OGD) / Office of Research and Standards (ORS). Significant progress has been made in the harmonization of bioequivalence (BE) guideline for solid oral immediate release (IR) products, and the ICH draft guideline for solid oral IR products (M13A) was endorsed on Dec 22, 2022. More efforts are needed to prepare for ICH harmonization for recommendations of BE studies on more complex topic areas such as solid oral modified release (MR) products. The objective of this project is to understand the difference and similarity of bioequivalence recommendations for solid oral MR by different regulatory agencies, collect bioequivalence data for in-depth scientific analysis, and provide a science-driven recommendations to ICH expert research groups.

Under the guidance of the mentor the participant will understand the landscape and BE requirements of solid oral MR and NTI drug products and develop skills to conduct in vitro or modeling and simulation studies for MR products.

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.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements:
If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

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

The qualified candidate should have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.

Previous knowledge of database management and analytics is preferred

Please apply at the following link: https://www.zintellect.com/Opportunity/Details/FDA-CDER-2023-1294

A complete application consists of:

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation
• All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER@orau.org . Please include the reference code for this opportunity in your email. (FDA-CDER-2023-1294)