Director, Medical Writing

10+ years of medical writing experience in the pharmaceutical or biotechnology industry, with significant experience preparing clinical and regulatory documents

eep experience authoring and reviewing clinical and regulatory documents

Ability to lead strategic discussions that align content and messaging across submissions,

Experience overseeing internal and external medical writing resources, including vendors, consultants, and cross-functional contributors

Strong understanding of FDA and international regulations, ICH guidelines, and regulatory processes related to document preparation, production, and submission, including CTD requirements

Experience developing and executing medical writing strategy across programs, submissions, or therapeutic areas

The Director, Medical Writing provides strategic leadership and hands-on execution

quality, compliant clinical and regulatory documents

supporting one or more development programs.

This role partners closely with Clinical Development, Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Research, Preclinical, Translational Biomarkers, Program Management, and Medical Affairs to ensure clear, consistent scientific messaging across key submissions to the FDA and global health authorities.

Operating with a high degree of independence, the Director drives document planning, authoring, review, and finalization in alignment with company priorities, SOPs, ICH/GCP guidance, and applicable regulatory requirements.

Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities