Associate Director, Medical Writing

About the role

This role will drive complex programs from planning through execution with a focus on structure, accountability, and measurable delivery. You will work across business leaders, delivery teams, and strategic partners to align priorities, manage dependencies, and keep initiatives on track. The position offers the opportunity to bring clarity to complex work and deliver outcomes that matter across the organization within a life sciences environment.

Location: Remote – US based candidates only, no visa sponsorship available

Compensation: $142,500 – $192,500 annually

Responsibilities

• Author phase 1-4 protocols, IBs, CSRs, and various regulatory documents
• Engage with SMEs to ensure accurate and consistent content
• Ensure inspection-readiness of medical writing activities
• Facilitate document standardization for quality across programs
• Manage medical writers and external contributors for regulatory documents
• Collaborate with project teams to meet deadlines
• Support the development and execution of corporate objectives and strategies

Qualifications

• Bachelor's degree in a scientific or clinical discipline; PhD preferred
• 5+ years of clinical/regulatory medical writing experience in pharma/biotech
• Fluent American English proficiency
• Experience with eCTD Module 2 and 5 writing for global MAAs
• Basic understanding of drug development processes and methodology
• Familiarity with regulatory guidance for medical writing documents
• Proficient in MS Office; knowledge of Veeva Vault preferred

Benefits

• Remote work flexibility
• Opportunity to expand medical writing department infrastructure
• Collaboration with diverse project teams in drug development
• Engagement with cutting-edge antibody therapeutics
• Supportive environment for professional development