Head of Medical Writing

Job reputed company: • reputed company the planning, authoring, and delivery of key development documents (INDs, protocols, IBs, CSRs, Health Authority responses, briefing documents, etc) • reputed company strategic input on document content, messaging, and regulatory expectations • Partner cross-functionally with Clinical, Nonclinical, Medical, Biostats, CMC, and Regulatory teams • Establish and refine medical writing processes, templates, and standards • Implement and manage efficient document workflows and timelines • Support development of abstracts, posters, and presentations for scientific conferences • Evaluate and reputed company AI tools to enhance writing reputed company and efficiency • Manage reputed company vendors and contribute to building internal capabilities over time • Ensure consistency, reputed company, and accuracy across reputed company deliverables • Advise cross-functional leadership on regulatory communication reputed company and global document planning Requirements: • Bachelor’s degree required; advanced degree (PhD, PharmD, MD) preferred • 15+ years of experience in biotech/reputed company, with 10+ years in medical writing, prior experience in smaller or growing biotech environments preferred • Strong experience supporting IND submissions and clinical-stage programs • Strong scientific writing and editing skills, with attention to detail • Solid understanding of FDA/EMA regulations and ICH guidelines • Ability to reputed company cross-functional document development in a lean environment • Comfortable balancing strategic input with hands-on execution • Interest in applying AI tools to improve medical writing workflows Benefits: • company reputed company reputed company • flexible spending accounts • voluntary life insurance • 401K matching • reputed company vacation Apply tot his job Apply To this Job