Director, Medical Writing

About the role

Beeline Medicines is seeking a Director of Medical Writing to lead the creation and delivery of high‑quality regulatory, clinical and non‑clinical documents supporting its immunology and inflammation pipeline. This senior, hands‑on position combines scientific authorship with functional leadership of the medical writing team.

Key responsibilities

• Author, coordinate and review core regulatory documents such as protocols, CSRs, IBs, IND/CTA submissions and selected NDA/BLA components.
• Define submission narrative strategy and ensure consistent scientific messaging across CTD modules.
• Plan and sequence document deliverables with cross‑functional teams, maintain integrated timelines and provide status updates.
• Manage and develop internal medical writing staff and contract writers, and oversee external vendors within budget.
• Establish and maintain SOPs, style guides and templates aligned with ICH and regional requirements, and train teams on these processes.

Required profile

• Advanced degree (PhD, PharmD or master’s) in life sciences, pharmacology or related field.
• 10+ years of medical writing experience in pharma/biotech, with extensive regulatory submission authorship.
• Deep knowledge of FDA, EMA and ICH guidelines (E3, E6, E8, M4).
• Proven ability to lead and mentor writing teams in a fast‑paced, resource‑constrained environment.

Required skills

• Proficiency with Veeva Vault or equivalent publishing platforms.
• Experience using document management and electronic submission systems.
• Hands‑on use of AI‑assisted authoring and review tools for regulatory documents.

What we offer

• Comprehensive health and wellness coverage.
• Paid time off and public holidays in accordance with local regulations.
• Flexible remote work arrangement with periodic on‑site visits.
• Competitive salary range $199,000–$258,000 USD plus discretionary bonus and equity.