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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
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Worksite address
california, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.