Regulatory Associate

Location
Westlake, Maryland
Posted
Oct 19, 2017
Ref
201796
Required Education
Bachelors Degree
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 dedicated team player to join our Bethesda, MD team.

Purpose:

-Reproduce simple and complex documents for submission to regulatory agencies and distribution to stakeholders.

-Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.

-Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.

-Draft, edit, and distribute various documents as needed based on templates and work instructions.

-Develop and maintain work process tools to promote efficiency and productivity.  These may include templates, SOPs, work instructions, checklists, etc.

-Track regulatory activity in a Clinical Trial Management System and ensure that records are complete and current.

-Provide other administrative regulatory support as needed.

Requirements: 

-Bachelor’s Degree in the Life Sciences or a related field with 0-2 years of work experience preferred

-Must have excellent verbal and written communication skills

-Superior organizational skills and customer service abilities are required

-Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus  

-Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects 

-Exposure to clinical trials, research, or a medical background is a plus