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
• Two educational or professional references

All documents must be in English or include an official English translation.

If you have questions, send an email to FDArpp@orau.org. Please include the reference code for this opportunity in your email.

 In 1972, FDA initiated an OTC drug monograph review process to evaluate the safety and effectiveness of thousands of marketed OTC products.  An OTC drug monograph serves as a kind of "rule book" for regulated industry in formulating OTC products by specifying "conditions of use" under which a given category of products are considered to be generally recognized as safe and effective (GRASE) and not misbranded. This review process is ongoing to finalize tentative final monographs (TFMs) and to modify other monographs to keep pace with changing science. 

The candidate will be responsible for researching specific monograph active ingredients and conditions that will be subject to FDA rulemaking. Responsibilities include providing summary data and analysis of available scientific literature and white papers submitted to the public docket and other activities per below:
-Conduct comprehensive literature search on specific monograph drug active ingredients or other monograph condition
-Summarize and analyze relevant data from the literature search
-Summarize and analyze key findings, limitations, and data gaps from white papers and published data submitted to the  
public docket
 
The literature search results and related analyses of publicly available information performed by the ORISE fellow will be used by DNDP regulatory scientists as background data for monograph reviews in support of FDA rulemaking related to Tentative and Final OTC Drug Monographs. 

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 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 or the program administrator, and there are no fringe benefits paid.

The participant should have recieved a doctoral degree in one of the related areas.

• Degree: Doctoral Degree received within the last 60 month(s).
• Discipline(s):
  • Chemistry and Materials Sciences (1 )
  • Life Health and Medical Sciences (3 )