Director of Medical Writing — AI Regulatory Narratives

Agomab; Antwerpen; Remote; EUR 100,000 - 180,000; Full time

Benefits offered by this job

Remote flexibility

Travel opportunities

Competitive salary

Job summary

Agomab seeks a Director of Medical Writing to lead narrative strategy, document quality, and cross-functional collaboration across clinical programs. The role oversees CRO medical writers, develops scalable processes, and guides AI-assisted tools with strong controls for oversight and confidentiality.

The position combines hands-on document development with strategic partnership to shape writing standards, tools, and submission-ready content across Phase 1–3 programs.

Qualifications

• Bachelor's degree in life sciences; an MS/PhD preferred.
• 10+ years regulatory medical writing in pharma/biotech with independent authorship of Phase 1–3 documents.
• Strong experience with protocols, CSRs, IBs, and regulatory agency briefing docs.
• Experience leading IND/CTA and eCTD supporting documents, CTD Module 2/5 summaries.
• Knowledge of global regulatory requirements and disclosure rules.
• Hands-on with AI-assisted tools in medical writing or regulatory settings.
• Ability to lead cross-functional initiatives and manage deadlines.

Responsibilities

• Lead authorship and narrative strategy for clinical/regulatory documents.
• Oversee CROs and external writers; ensure timely deliverables.
• Develop and maintain medical writing standards, templates, and SOPs.
• Pilot AI-assisted workflows with controls for risk, traceability and quality.
• Collaborate with Regulatory Affairs, Clinical Development, Biostatistics, and Pharmacovigilance.

Skills

Medical writing leadership

Regulatory writing

Project management

CRO management

AI in medical writing

Cross-functional collaboration

ICH E3 knowledge

CTD/eCTD familiarity

Education

Bachelor in life sciences

MS/PhD preferred

Tools

Veeva Vault

Please Review

CTD/eCTD standards

Job description

Agomab seeks a Director of Medical Writing to lead narrative strategy, document quality, and cross-functional collaboration across clinical programs. The role oversees CRO medical writers, develops scalable processes, and guides AI-assisted tools with strong controls for oversight and confidentiality.

The position combines hands-on document development with strategic partnership to shape writing standards, tools, and submission-ready content across Phase 1–3 programs.