Senior Manager, Medical Writing

About This Role

This role is for a strategic medical writing professional to lead diverse medical writing activities across the drug portfolio, craft compelling submission-ready documents, and shape regulatory communication for a tech and AI-driven pharma company.

Responsibilities

• Drive medical writing across multiple programs spanning diverse document types including regulatory submissions, clinical protocols, investigator’s brochures (IBs), clinical study reports (CSRs), safety narratives, and briefing documents
• Own project timelines and processes for medical writing deliverables, proactively identifying risks, adapting processes, and driving resolution across teams
• Partner with leading-edge AI tools to help build the playbook for AI-augmented medical writing
• Work alongside the current head of medical writing to build a medical writing department from the ground up
• Partner with Regulatory on developing regulatory strategy, alongside broader program strategy influenced by Clinical and Nonclinical scientific teams
• Develop and maintain Formation-specific document templates, style guides, and quality standards
• Manage relationships with external medical writing vendors when needed, ensuring quality and alignment with internal standards
• Advise cross-functional teams on regulatory communication best practices and emerging guidance

Requirements

• Deep expertise across the full range of clinical, nonclinical, and regulatory documents, including Phase 1 to Phase 3 protocols, IBs, CSRs, CTD modules, and briefing documents
• Proven track record supporting IND/CTA submissions and NDA/BLA preparation
• Experience managing medical writing deliverables for multiple concurrent programs at different development stages
• Experience with industry standard templates and deep understanding of regulatory guidance
• Strong project management capabilities with demonstrated ability to coordinate detailed drafting and review timelines and coordinate across functions
• Excellent understanding of ICH guidelines, FDA/EMA regulatory requirements, and industry best practices
• Ability to translate complex scientific and clinical data into clear, compelling narratives
• Experience managing external writers or writing vendors
• Ability to operate independently while building strong internal relationships

Qualifications

• Advanced degree (PhD or PharmD) in a scientific discipline, or BS/MS degree
• 3-5+ years of experience in pharmaceutical or biotech medical writing with an advanced degree, or 8-12+ years with a BS/MS degree

Nice to Have

• Experience with accelerated regulatory pathways
• Familiarity with global submission requirements beyond FDA and EMA
• Prior experience scaling medical writing bandwidth using contractors and/or modern technology
• Experience with biologics and small molecules
• Background in both small biotech companies and mid-to-large pharma
• Track record of contributing to successful regulatory submissions ranging from FIH IND applications to NDA/BLA approvals
• Applied knowledge of and demonstrated ability to use AI and modern technology tools that enhance writing efficiency

Skills

* Required skills

Benefits