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