Regulatory Operations Associate
Company: Beacon Hill Staffing Group
Posted on: June 20, 2022
- 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
- Demonstrated experience with databases and database
- 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
- 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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