FDA Office of Global Policy and Strategy Fellowship

Position description

About the position

• Applications will be reviewed on a rolling-basis. Early submission of applications is strongly encouraged. A selection may be made at any time during the review process.

An opportunity is available at the U.S. Food and Drug Administration (FDA), Office of the Commissioner (OC), Office of Global Policy and Strategy (OGPS) located in Silver Spring, Maryland.

The Office of Global Policy and Strategy covers all regulated commodities that are imported into the United States from a policy perspective, and the program office is seeking two ORISE fellows to:

• Perform qualitative and quantitative analysis on how the agency can best leverage multilateral institutions such as the WHO, PAHO, OECD, ASEAN, and APEC to advance the agencies public health priorities.
• Learn FDA's regulatory programs and conduct qualitative and quantitative analysis to inform regulatory cooperation activities and OGPS strategy for priority areas including: supply chain resilience and oversight, regulatory systems strengthening, health equity, and good aquaculture practices.
• Support international policy and strategy workgroups which overlap FDA functional units by developing analytical research papers. Research papers should establish the current ""state-of-play"" for a specific issue while identifying potential public health risks and opportunities for FDA to strengthen oversight of imported products.

Anticipated Appointment Start Date: August 2023; start date is flexible

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.

Qualifications

The qualified candidate should have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within the past two years.

Preferred skills:

• Quantitative Analysis
• Qualitative Analysis
• Global Health
• Public Health
• Regulatory Policy
• Pharmacology
• Health Communications
• International Relations

Application instructions

Please be sure to indicate you saw this position on Globaljobs.org