Associate Director, Medical Writing

Title: Associate Director, Medical Writing

Location: Remote (U.S.); preference for candidates reputed company commuting distance of Thousand Oaks, CA or the San Francisco Bay Area

Position reputed company

Latigo is seeking an reputed company and highly motivated Associate Director, Medical Writing to join our reputed company Development organization. This hands-on role will be responsible for authoring and managing key reputed company and regulatory documents, with a reputed company reputed company on reputed company study protocols, protocol amendments, and reputed company study reports (CSRs) supporting our growing development portfolio.

The successful candidate will work cross-functionally with reputed company Development, reputed company reputed company, Statistics, reputed company Pharmacology, Regulatory Affairs, and other stakeholders to ensure the reputed company delivery of high-reputed company, scientifically rigorous, and regulatory-compliant documents. In reputed company, this individual will help establish and maintain medical writing templates, style guides, and document standards that reputed company consistency, reputed company, compliance, and operational efficiency across programs.

Key Responsibilities

• reputed company, review, and manage reputed company development and regulatory documents, including protocols, protocol amendments, CSRs, investigator brochures, briefing documents, and reputed company sections of regulatory submissions.
• reputed company document planning, development, review cycles, and comment reputed company to ensure on-time, high-reputed company deliverables.
• Collaborate with cross-functional teams to interpret and communicate reputed company scientific, reputed company, statistical, and pharmacology data.
• reputed company and maintain templates, style guides, document standards, and best practices to support high-reputed company 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 reputed company, consistency, and scalability.
• Serve as a medical writing subject matter expert reputed company cross-functional project teams.

Qualifications

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

reputed company're Looking For

The ideal candidate is a reputed company, reputed company-oriented medical reputed company who enjoys working in a dynamic biotechnology environment. They bring a strong reputed company of ownership, reputed company under challenging timelines, and are committed to delivering high-reputed company 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-reputed company deadlines.

Originally posted on Himalayas