Backed by 5AM Ventures.
About the role
Latigo is seeking an experienced and highly motivated Associate Director, Medical Writing to join our Clinical Development organization. This hands-on role will be responsible for authoring and managing key clinical and regulatory documents, with a primary focus on clinical study protocols, protocol amendments, and clinical study reports (CSRs) supporting our growing development portfolio.
What they're looking for
- Author, review, and manage clinical development and regulatory documents, including protocols, protocol amendments, CSRs, investigator brochures, briefing documents, and clinical sections of regulatory submissions
- Lead document planning, development, review cycles, and comment resolution to ensure on-time, high-quality deliverables
- Collaborate with cross-functional teams to interpret and communicate complex scientific, clinical, statistical, and pharmacology data
- Develop and maintain templates, style guides, document standards, and best practices to support high-quality and efficient document production
- Ensure compliance with FDA regulations, ICH guidelines, GCP, and other applicable regulatory requirements
- Contribute to INDs and other global regulatory submissions, including regulatory responses and supporting documentation
More about this role
Title: Associate Director, Medical Writing
Position Summary
Latigo is seeking an experienced and highly motivated Associate Director, Medical Writing to join our Clinical Development organization. This hands-on role will be responsible for authoring and managing key clinical and regulatory documents, with a primary focus on clinical study protocols, protocol amendments, and clinical study reports (CSRs) supporting our growing development portfolio.
The successful candidate will work cross-functionally with Clinical Development, Clinical Operations, Statistics, Clinical Pharmacology, Regulatory Affairs, and other stakeholders to ensure the timely delivery of high-quality, scientifically rigorous, and regulatory-compliant documents. In addition, this individual will help establish and maintain medical writing templates, style guides, and document standards that drive consistency, quality, compliance, and operational efficiency across programs.
Key Responsibilities
- Author, review, and manage clinical development and regulatory documents, including protocols, protocol amendments, CSRs, investigator brochures, briefing documents, and clinical sections of regulatory submissions.
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