Director, Medical Writing Job at Brio Group in california
Brio Group, california, mo, United States
Lead authoring of key documents (protocols, CSRs, IBs) across Phase I–IV. Partner with Clinical, Regulatory, and Biostats to align on timelines and strategy. Ensure all deliverables meet global regulatory standards and quality expectations. Drive consistency, efficiency, and best practices across medical writing. Contribute to submission readiness and regulatory filings.
Responsibilities
- Lead authoring of key documents (protocols, CSRs, IBs) across Phase I–IV
- Partner with Clinical, Regulatory, and Biostats to align on timelines and strategy
- Ensure all deliverables meet global regulatory standards and quality expectations
- Drive consistency, efficiency, and best practices across medical writing
- Contribute to submission readiness and regulatory filings
Qualifications
- 8+ years of medical writing experience in biotech/pharma/CRO
Required Skills
- Strong experience supporting clinical/regulatory documents
- Deep understanding of the drug development process
- Ability to translate complex data into clear, concise content
- Proven ability to manage multiple priorities in a fast-paced environment