Regulatory Specialist

Location
Bethesda, MD
Posted
Feb 04, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients.  TRI is currently seeking a Regulatory Specialist to join our Bethesda, MD team.

  • Preparing scientific and regulatory documents (e.g. clinical protocols, investigator’s brochures, informed consent forms, annual reports, investigational new drug applications, new drug applications, regulatory correspondence, and clinical summary reports).
  • Ability to prepare investigator/pharmaceutical company meeting minutes, analyze preclinical and clinical data, prepare reports, perform literature searches and extract information to support regulatory documents.
  • Attend scientific meetings and reviews the literature to stay current with new developments in the infectious disease fields.
  • Perform Protocol Regulatory Reviews

Requirements include a M.S. degree or equivalent with 5 or more years of relevant work experience or a Ph.D. with 1 or more years of relevant work experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, or a related field; knowledge of US and non-US regulatory requirements; excellent oral, written, and interpersonal skills; high attention to detail; ability to analyze medical research data and review experimental protocols; and working knowledge of word processing, Adobe Acrobat, spreadsheet, and database management programs. 

Submit resume and salary requirements to:  Attn: AF, TRI, 6500 Rock Spring Dr, Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or email to HR@tech-res.com.

Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.