Regulatory Writer and/or Regulatory QC/ Editor
New
V
Vir BiotechnologyBiopharmaceutical
Remote - United StatesContractMiddle
Salary90 - 120 USD per hour
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Job Details
- Experience
- 5 plus years
Requirements
- Bachelor’s degree and 5+ years of relevant experience.
- Working knowledge of the industry and content of key eCTD documents.
- Familiarity with CTD/eCTD structure and common regulatory templates.
- Understanding of drug development and regulatory submission processes, including ICH guidelines and major health authority expectations (e.g., FDA, EMA).
- 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 (e.g., Veeva Vault).
- Experience with project and timeline management systems (e.g., SmartSheet).
Responsibilities
- Write and edit regulatory documents, including clinical trial protocols, amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and regulatory submission dossiers.
- Perform independent QC reviews of documents to verify accuracy and internal/external consistency against source materials.
- Review documents for adherence to style guides (e.g., AMA Manual of Style), templates, and regulatory guidance.
- Proofread and copyedit text to ensure clarity, grammar, and scientific/regulatory accuracy.
- Support the preparation and inspection-readiness of technical documents for global regulatory submissions, including integration of narratives, tables, and statistical output.
- Communicate QC findings constructively and collaborate with cross-functional stakeholders to resolve issues.
- Facilitate project management of document workflows from kickoff through publishing.
- Contribute to the continuous improvement of QC processes, checklists, and best practices.
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