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Regulatory Operations Associate

Company: Beacon Hill Staffing Group
Location: Bethesda
Posted on: June 20, 2022

Job Description:

Responsibilities

  • Prepare standard documentation supporting regulatory filings 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, maintain and update databases, and ensure that records are complete and current.
  • Provide other administrative regulatory support as needed.Requirements
    • Demonstrated experience with databases and database management
    • Demonstrated experience maintaining documents
    • Experience with clinical documents is a plus
    • Demonstrated experience with the Microsoft office suite
    • Must have excellent attention to detail, as well as strong verbal and written communication skills.
    • Superior organizational skills and customer service abilities are required.
    • Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
    • 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.
    • Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable.
    • General knowledge of the drug and vaccine development process or clinical trials is a plus.

Keywords: Beacon Hill Staffing Group, Bethesda , Regulatory Operations Associate, Other , Bethesda, Maryland

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