Director, Medical Writing

Brio Group; California (MO); On-site; USD 100,000 - 130,000; Full time

Job summary

Brio Group seeks an experienced Lead Medical Writer located in California, Missouri. This role requires a minimum of 8 years of medical writing experience in the biotech/pharma/CRO sector. Responsibilities include authoring key documents for clinical trials, ensuring all deliverables meet global regulatory standards, and collaborating with various departments for alignment on strategies. Candidates with a strong background in clinical and regulatory documents are preferred. Join Brio Group to contribute to regulatory submissions and drive best practices in medical writing.

Qualifications

• 8+ years of medical writing experience in biotech/pharma/CRO.

Responsibilities

• Lead authoring of key documents across Phase I–IV.
• Partner with Clinical, Regulatory, and Biostats to align on timelines and strategy.
• Ensure all deliverables meet global regulatory standards.
• Drive consistency and best practices across medical writing.
• Contribute to submission readiness and regulatory filings.

Skills

Supporting clinical/regulatory documents

Translating complex data into clear content

Managing multiple priorities

Job description

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