PT Research Analyst foreign drug-medicines marketing regulatory experience
FEFA, LLC - Silver Spring, MD

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FEFA, a government consulting scientific firm, has a current opening for a Part Time Research Analyst to perform services from 9-15-2013 to 3-14-2014, approximately 60 hours of service per month. The scope of this position includes:

(1) the research and reporting on a select number of foreign drug regulatory histories, foreign drug marketing requirements, foreign drug exports requirements, foreign drug imports requirements; and
(2) the identification of applicable public health laws;

Other position responsibilities include:

  • Provide an analysis of the regulatory history, including but not limited to the use of congressional and legislative sources, of FDCA Chapter 8 and promulgated regulations with a focus on drug imports and exports. This should include scholarly references and bibliography.
  • Provide outlines of foreign drug/medicines marketing regulatory systems or requirements for a limited number of foreign countries.
  • Compile public foreign governmental regulatory resources, including laws that apply to the importation/exportation of drugs/medicines and provide updates within the contract period as appropriate.
  • Make recommendations to facilitate the targeting of drug import compliance actions including but not limited to the early identification of products requiring more extensive review, and conversely, products not requiring an extensive review process.
  • Act in a consultative manner, proactively searching for creative solutions and strategies relating to understanding foreign drug/medicine marketing regulatory requirements.
  • Submit status reports

Education and Experience:
Must have education and experience with legal and regulatory research with a background in public health policy. Knowledge and experience with adequate scholarly and professional research resources. Knowledge and experience in developing analytical reports that summarize public health regulations and identify regulatory resources.