FDA Emerging Issues in Controlled Substances Fellowship

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDER-2021-0697
How to Apply

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A complete application consists of:      

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.

Application Deadline
12/31/2021 3:00:00 PM Eastern Time Zone
Description

*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 the Center Director/ Controlled Substances Program (CSP) located in Silver Spring, Maryland.

The project will explore emerging public health and policy issues related to controlled substances (e.g., opioids and stimulants). The Controlled Substances Program works to promote public health by enabling appropriate access to controlled substances for medical use, while seeking to minimize risks associated with problematic use. Through scientific research, policy analysis, stakeholder engagement, interagency collaborations, and literature and news reviews, this project will help enhance CDER’s data-driven approach to combating the opioid epidemic.

Under the guidance of the mentor, the participant will learn how to use tools such as the Opioids Data Warehouse and conduct structured analysis of policy, news, and literature. Additionally, the participant will be included in meetings with CDER staff and other stakeholders and receive regular written and oral feedback on analysis and communications.

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 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 bachelor's, master's or doctoral degree, or currently be pursuing a master's or doctoral degree, in one of the relevant fields. Degree must have been received within the past five years.

Preferred skills/knowledge:

  • Experience with analyzing, visualizing, and communicating scientific data
  • Knowledge of public health and public policy
Point of Contact
Eligibility Requirements
  • Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree.
  • Discipline(s):
    • Computer, Information, and Data Sciences (17 )
    • Engineering (2 )
    • Life Health and Medical Sciences (46 )
    • Mathematics and Statistics (4 )
    • Other Non-Science & Engineering (2 )
    • Social and Behavioral Sciences (12 )
Affirmation

I have received a bachelor's, master's or doctoral degree within the past 60 months, or am currently pursuing a master's or doctoral degree.

AND

I have lived in the United States for at least 36 out of the past 60 months (36 months do not have to be consecutive.)

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