Associate Director, Medical Writing

The role

Own day-to-day medical writing for the company's immunology and inflammation pipeline, including authoring and reviewing regulatory and clinical documents. Coordinate internal and external writers, manage document timelines, and work with Clinical Development, Regulatory Affairs, and Biostatistics.

What you will do

• Own day-to-day execution of medical writing activities and coordinate internal and external resources for on-time delivery
• Author, coordinate, and review protocols, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and selected BLA/NDA components
• Lead scientific messaging consistency across CTD modules and shape submission narratives
• Collaborate with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs on document deliverables
• Provide guidance and oversight to internal and external medical writers, including vendor management
• Own document timelines and maintain integrated trackers across programs
• Establish the authoring, review, QC, and approval process for regulatory documents and develop training materials
• Support Health Authority briefing documents, meeting packages, and responses to Agency queries

Required qualifications

• Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline
• Minimum 7+ years of medical writing experience in pharmaceutical or biotech
• Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages
• Thorough knowledge of FDA and EMA regulatory writing requirements and ICH E3, E6, E8, and M4 guidelines
• Demonstrated ability to manage multiple concurrent document deliverables and writing teams
• Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated environment
• Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent
• Ability to lead, mentor, and develop cross-functional teams
• Exceptional written and verbal communication skills for diverse audiences, including executives and external partners

Nice to have

• Deep scientific expertise in immunology, inflammation, or autoimmune disease
• Ability to rapidly acquire technical knowledge in new therapeutic areas

Benefits

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave in accordance with local requirements
• Flexible work arrangements and hybrid schedule

Before you apply

• Benefits and pay vary by location and are subject to eligibility and local regulations
• It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment

About the company

Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. Its pipeline targets key pathways governing dysregulated immunological and inflammatory responses.