A research opportunity is available at the FDA, Center for Drug Evaluation and Research (CDER), Office of the Center Director, Controlled Substances Program (CSP).

The CSP aims to promote the public health by minimizing rsks associated with problematic use of controlled substances while enabling appropriate access for medical use. CSP’s core functions include: Proactively identifying and analyzing emerging issues with controlled substances and related strategies and initiatives that could help drive appropriate access; Providing technical expertise on drug assessment and scheduling, and consultation services for specific drug applications; Serving to coordinate and support CDER’s work on controlled substance policies and programs with internal and external stakeholders; and communicating with external stakeholders, including other government agencies, industry, and academia, on emerging issues and ongoing initiatives and policies at FDA around controlled substances.

The research project will explore emerging public health and policy issues related to controlled substances (e.g., opioids and stimulants). 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 a 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 will receive regular written and oral feedback on analysis and communications. 

This program, administered by Oak Ridge Associated Universities (ORAU) through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education (ORISE), was established through an interagency agreement between the Department of Energy (DOE) and FDA. The initial appointment for this research opportunity is 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. 

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. The 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

Degree: Bachelor’s Degree, Master’s Degree, or Doctoral Degree

Disciplines:

• Computer, Information, and Data Sciences

• Engineering

• Life Health and Medical Sciences

• Mathematics and Statistics

• Other Non-Science and Engineering Disciplines

• Social and Behavioral Sciences

Please submit your letter of interest, resume, and transcripts to: CDERCSP@fda.hhs.gov with the subject line of “FDA Emerging Issues in Controlled Substances ORISE Fellowship.” Questions may also be directed to the CDER CSP mailbox. Applications will be reviewed and interviews will be scheduled on a rolling basis.