Director, Medical Writing — AI-Driven Regulatory Lead (Remote)

Agomab; Tulsa (OK); Remote; USD 150,000 - 230,000; Full time

Benefits offered by this job

Remote and flexible working

Travel opportunities

Competitive salary

Job summary

Agomab is seeking a Director of Medical Writing to lead narrative strategy, document quality, and cross-functional collaboration across clinical programs. This role oversees CRO medical writers and builds scalable processes for Phase 3 progression, while piloting AI-assisted workflows with appropriate controls.

The position combines hands-on document development with strategic leadership, shaping Agomab's medical writing standards, processes, and tools for global regulatory submissions.

Qualifications

• Bachelor's degree in life science or related field.
• 10+ years regulatory medical writing experience in pharma/biotech.
• Experience with IND/CTA and eCTD documents.
• Knowledge of global regulatory requirements and CTD/eCTD standards.
• Experience leading CROs and external writers.

Responsibilities

• Lead authorship and narrative strategy for clinical and regulatory documents.
• Develop and maintain medical writing standards and SOPs.
• Manage CROs and external writers to ensure quality and timelines.
• Evaluate AI-assisted tools and establish risk controls.
• Collaborate with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and Pharmacovigilance.
• Plan resources and drive timely completion of documents.

Skills

Regulatory writing

IND/CTD knowledge

CTD/eCTD standards

Project leadership

AI in writing

Cross-functional collaboration

Quality control

Education

Bachelor's degree in life science

MS/PharmD/PhD preferred

Tools

Veeva Vault

Please Review

Job description

Agomab is seeking a Director of Medical Writing to lead narrative strategy, document quality, and cross-functional collaboration across clinical programs. This role oversees CRO medical writers and builds scalable processes for Phase 3 progression, while piloting AI-assisted workflows with appropriate controls.

The position combines hands-on document development with strategic leadership, shaping Agomab's medical writing standards, processes, and tools for global regulatory submissions.