Role OverviewLead the development and execution of high-quality clinical and regulatory documentation, ensuring compliance with global regulatory standards.
What You Will Do
Author and oversee the development of key clinical and regulatory documents, manage priorities, timelines, and quality expectations for outsourced work, and contribute to process and quality improvement.
Why It Might Be a Fit
The ideal candidate brings a combination of strong scientific expertise, project leadership, and the ability to collaborate effectively across internal teams, external partners, and vendors.
Requirements
- Advanced degree in a life sciences field (Master's required; PhD or PharmD preferred)
- 8+ years of medical or scientific writing experience within biotech, pharmaceutical, or CRO environments
- Deep familiarity with global regulatory requirements (e.g., ICH, FDA, EMA, Health Canada, APAC guidelines)
- Demonstrated experience authoring a broad range of clinical and regulatory documents
- Experience supporting Investigator-Initiated Trials and collaborating with external investigators
- Proficiency with tools such as Microsoft Office, Adobe Acrobat, and document management/review platforms (e.g., SharePoint, Veeva RIM)
- Experience managing external vendors and/or contract writers
- Strong organizational skills and attention to detail
- Excellent written and verbal communication abilities
- Self-starter with the ability to operate in a fast-paced, evolving environment
]]>