Remote Director of Medical Writing & Strategy

Beeline Medicines; United States; Remote; USD 199,000 - 258,000; Full time

Job summary

Beeline Medicines is seeking a Director, Medical Writing to lead the design and execution of regulatory, nonclinical and clinical documents across our I&I pipeline. The role blends hands-on writing with people leadership, vendor management, budget forecasting, and process development to ensure high-quality, regulator-ready deliverables.

You will partner with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs and external writers to plan, author, review, and deliver INDs,

Qualifications

• 10+ years of medical writing experience in pharma/biotech.
• Experience overseeing regulatory submissions in ICH CTD format (CSRs, ISS/ISE, IBs, IND/CTA).
• Strong ability to lead and mentor multi-disciplinary teams.
• Excellent written and verbal communication with stakeholders.

Responsibilities

• Lead day-to-day medical writing activities for regulatory and clinical documents.
• Define submission narratives and ensure content consistency across CTD modules.
• Oversee planning, timelines, and review cycles across programs.
• Manage internal staff and external vendors, including budget ownership.
• Develop SOPs, templates, and training to ensure regulatory compliance.

Skills

Regulatory writing

Medical writing leadership

IND/CTA submissions planning

FDA/EMA guidelines

Vendor management

Budget management

Cross-functional collaboration

ICH CTD familiarity

CTD modules coordination

Editorial leadership

Education

Advanced degree (PhD, PharmD, or master's) in life sciences

Tools

Veeva Vault

Document management systems

Publishing platforms

Job description

Beeline Medicines is seeking a Director, Medical Writing to lead the design and execution of regulatory, nonclinical and clinical documents across our I&I pipeline. The role blends hands-on writing with people leadership, vendor management, budget forecasting, and process development to ensure high-quality, regulator-ready deliverables.

You will partner with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs and external writers to plan, author, review, and deliver INDs,