Director, Medical Writing

The role

The Director, Medical Writing is a hands-on leadership role responsible for scientific messaging and the development of regulatory, nonclinical, and clinical documents. This person will manage medical writing processes, internal staff, and external vendors to support the company's I&I pipeline.

What you will do

• Author, coordinate, and review clinical and regulatory documents including protocols, CSRs, IBs, SAPs, ICFs, and IND/CTAs.
• Define strategy for submission narratives and scientific messaging.
• Direct planning and sequencing of document deliverables with cross-functional teams.
• Manage and develop medical writing staff and contract writers.
• Manage medical writing vendors, including selection, scope, and performance.
• Own the Medical Writing budget and forecast internal and vendor capacity.
• Establish and maintain processes for authoring, review, QC, and approval of regulatory documents.
• Support Health Authority briefing documents and responses to Agency queries.
• Represent Medical Writing in cross functional and governance forums.

Required qualifications

• Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline
• Minimum of 10+ years of medical writing experience in the pharmaceutical or biotech industry
• Extensive experience authoring and overseeing regulatory submissions in ICH CTD format
• Demonstrated ability to manage multiple concurrent document deliverables and writing teams
• Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and pharmacovigilance documentation standards
• Experience developing and enforcing Medical Writing SOPs, style guides, and document templates
• Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent
• Strong publication planning experience including ICMJE authorship guidelines and journal submission processes
• Demonstrated ability to lead, mentor, and develop cross-functional teams
• Proven track record of influencing without authority across organizational boundaries
• Exceptional written and verbal communication skills

Nice to have

• Deep scientific expertise in immunology, inflammation, or autoimmune disease
• Proficiency with AI-assisted authoring and review tools
• Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization

Benefits

• Competitive health and wellness coverage
• Paid time off
• Public holidays
• Additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

About the company

Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.