United States · Remote
Full-time
Lead / Manager
1 week ago
Apply link not verified recently — we re-check every 2 hours
$200k – $220k
Title: Associate Director, Medical Writing Location: Remote (U.S.); preference for candidates within commuting distance of Thousand Oaks, CA or the San Francisco Bay Area 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. 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. Qualifications 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. Experience with clinical pharmacology content is preferred. Excellent scientific writing, communication, organizational, and project management skills. Ability to manage multiple projects and competing priorities in a fast-paced environment. What We're Looking For The ideal candidate is a collaborative, detail-oriented medical writer who enjoys working in a dynamic biotechnology environment. They bring a strong sense of ownership, thrive under challenging timelines, and are committed to delivering high-quality work that supports critical development milestones and regulatory submissions. Candidates should be willing to travel periodically for team meetings and other business needs and demonstrate flexibility to support occasional extended hours during periods of intensified activity and submission-related deadlines. Salary: $200,000 - $220,000 Originally posted on Himalayas
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