Senior Director, Medical Writing — Remote Strategy Lead

Agomab Therapeutics; Boston (MA); On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Remote with travel

Competitive salary

Flexible work arrangements

Job summary

Agomab Therapeutics seeks a Senior Director of Medical Writing to anchor our hybrid medical writing model across all programs, owning narrative strategy and document quality. You will balance AI-enabled tools with regulatory rigor, partnering with Regulatory Affairs, Clinical Development, Biostatistics, and Pharmacovigilance to shape the program development story and ensure audit-ready submissions.

You will lead CRO relationships, set standards, templates, and training, and drive scalable

Qualifications

• Bachelor's degree (BS) required; advanced degree (MS, PharmD, or PhD) preferred.
• Minimum 15 years of regulatory medical writing experience in pharma/biopharma.
• Expertise in CTD process and submission guidelines.
• Experience authoring protocols, CSR, IBs and regulatory agency briefing documents.
• Experience managing CRO medical writing and AI tool adoption.

Responsibilities

• Author and lead development of core regulatory and clinical documents across programs (Phase 1–3).
• Own narrative strategy ensuring scientific accuracy and alignment with development strategy.
• Edit IND/NDA/eCTD documents and summaries for submissions.
• Establish documentation standards and templates; drive innovative solutions.
• Oversee CRO medical writing engagements and external vendors.

Skills

Regulatory writing

Clinical documents

Strategic leadership

Cross-functional collaboration

AI in medical writing

Education

BS life sciences

MS/PhD preferred

Tools

Veeva Vault

eCTD tools

Job description

Agomab Therapeutics seeks a Senior Director of Medical Writing to anchor our hybrid medical writing model across all programs, owning narrative strategy and document quality. You will balance AI-enabled tools with regulatory rigor, partnering with Regulatory Affairs, Clinical Development, Biostatistics, and Pharmacovigilance to shape the program development story and ensure audit-ready submissions.

You will lead CRO relationships, set standards, templates, and training, and drive scalable