Senior Director, Medical Writing & Regulatory Strategy

Agomab Therapeutics; Cambridge (MA); Hybrid; USD 180,000 - 300,000; Full time

Benefits offered by this job

Pioneering science with young biotech

Challenging and innovative work

US-based with remote travel to Belgium

Competitive salary and benefits

Fast-paced environment

Job summary

Agomab Therapeutics is seeking a Senior Director of Medical Writing to lead the regulatory writing function across multiple programs. This strategic role embeds within Regulatory Affairs, partnering with Clinical Development, Biostatistics, and Pharmacovigilance to shape narrative strategy, improve document quality, and ensure submission readiness.

The role emphasizes AI-enabled tools, cross-functional collaboration, and an inspections-ready framework to scale as programs advance to Phase 3 and

Qualifications

• Bachelor's degree in life sciences; advanced degree preferred.
• Minimum 15 years regulatory medical writing experience in pharma/biopharma.
• Extensive CTD/IND/NDA/eCTD knowledge and cross-functional collaboration.
• Experience drafting regulatory documents and leading CRO engagements.
• Ability to manage multiple documents across programs under tight deadlines.

Responsibilities

• Author and lead core regulatory and clinical documents across programs (Protocols, CRSs, IBs, briefings).
• Own narrative strategy for each document ensuring accuracy and alignment with development plans.
• Draft and edit IND/NDA/eCTD submissions including CTD Module 2/5 summaries.
• Establish and maintain documentation standards, templates, and best practices.
• Review docs for clarity, regulatory compliance, and audit readiness.
• Support manuscripts and abstracts with clinical teams.
• Lead AI-enabled drafting initiatives and tool adoption.
• Manage CRO medical writing engagements and external writers.
• Define KPIs and drive improvements in cycle time, quality, and efficiency.

Skills

Regulatory writing leadership

Clinical document drafting

AI in medical writing

Cross-functional collaboration

Project management

Strategic thinking

Education

Bachelor's degree in life sciences

Advanced degree (MS/PhD/PharmD)

Tools

Veeva Vault

AI drafting tools

Job description

Agomab Therapeutics is seeking a Senior Director of Medical Writing to lead the regulatory writing function across multiple programs. This strategic role embeds within Regulatory Affairs, partnering with Clinical Development, Biostatistics, and Pharmacovigilance to shape narrative strategy, improve document quality, and ensure submission readiness.

The role emphasizes AI-enabled tools, cross-functional collaboration, and an inspections-ready framework to scale as programs advance to Phase 3 and