A World Without Infectious Disease
Regulatory Writer – Regulatory QC/Editor
Location
United States
Posted
2 days ago
Salary
$90 - $120 / hour
Seniority
Senior
Job Description
Regulatory Writer – Regulatory QC/Editor
Vir Biotechnology, Inc.
• Write and edit a wide range of regulatory documents • Perform independent QC reviews of documents produced by the regulatory writing function • Verify the accuracy and internal/external consistency of documents • Define and confirm the scope of QC activities with document authors • Review documents for adherence to applicable style guides • Proofread and copyedit text to ensure clarity and accuracy • Support preparation and inspection‑readiness of technical documents • Communicate QC findings clearly and constructively to stakeholders • Facilitate the efficient project management of individual document workflows • Contribute to the continuous improvement of QC tools, checklists, and processes
Job Requirements
- Bachelor’s degree and 5 plus years of relevant experience
- Working knowledge of the industry and content of key eCTD documents
- Understanding of drug development and regulatory submission processes
- Exceptional attention to detail with strong analytical and critical‑thinking skills
- Proven ability to manage multiple tasks and priorities in a deadline‑driven environment
- Experience working cross‑functionally in collaborative team environments
- Experience with electronic document management and publishing systems
- Experience with project and timeline management systems
Benefits
- Health insurance
- Flexible work hours
- Paid time off
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