Associate Director, Medical Writing

Latigo Bio • Thousand Oaks, CA

1d • $200,000 - $220,000 • Remote

About The Position

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.

Requirements

• Master's degree or higher in life sciences, pharmacy, nursing, health sciences, or a related scientific discipline.
• Minimum 8 years of medical writing experience in the biotechnology, pharmaceutical, or CRO industry.
• Demonstrated expertise authoring clinical study protocols and clinical study reports.
• Experience supporting INDs, CTAs, and/or other regulatory submissions.
• Strong understanding of clinical drug development and regulatory requirements.
• Excellent scientific writing, communication, organizational, and project management skills.
• Ability to manage multiple projects and competing priorities in a fast-paced environment.

Nice To Haves

• Experience with clinical pharmacology content is preferred.

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.
• 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.
• Support process improvement initiatives that enhance medical writing quality, consistency, and scalability.
• Serve as a medical writing subject matter expert within cross-functional project teams.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager