- Prepare clinical regulatory documents for public disclosure
- Regulatory requirements include EMA policy 0700, EU Clinical Trial Regulation, Health Canada, policies/SOPs, and more.
- Vendor management to plan and manage time lines for disclosure deliverables in compliance with regulatory requirements
- Communicates all regulatory medical writing responsibilities to project teams within clinical documents, reviewing deliverables and completion of disclosures
- 5+ years of experience in regulatory affairs, regulatory operations, or medical writing
- Relevant experience within clinical trials and clinical research concepts
- Ability to work independently
- Prior experience within eCTD format