Iambic Therapeutics, Inc - Head of Medical Writing

San Diego, California, United States$224k - $280k1mo ago

Remote Director NA Pharmaceuticals Biotechnology Physician Documentation

Requirements

• Bachelor’s degree required; advanced degree (PhD, PharmD, MD) preferred • 15+ years of experience in biotech/pharma, 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 lead 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

Responsibilities

• Lead the planning, authoring, and delivery of key development documents (INDs, protocols, IBs, CSRs, Health Authority responses, briefing documents, etc) • Provide 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 integrate AI tools to enhance writing quality and efficiency • Manage external vendors and contribute to building internal capabilities over time • Ensure consistency, quality, and accuracy across all deliverables • Advise cross-functional leadership on regulatory communication strategy and global document planning

Benefits

• We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.