Job Description

Our Boston based pharmaceutical client is looking for a Senior Director of Medical Writing to lead the strategy, delivery, and quality of clinical and regulatory documents across their portfolio. This role partners closely with R&D teams, manages external writing vendors, and will help shape a scalable medical writing model as their programs grow.

What you’ll do:

• Lead medical writing strategy, forecasting, and resource planning
• Manage vendor selection, contracting, and performance
• Author and oversee key clinical and regulatory documents (protocols, CSRs, IBs, Module 2 summaries, etc.)
• Ensure accuracy, consistency, and compliance with ICH/GCP/eCTD and internal standards
• Drive process improvements, SOP development, and best practices
• Represent Medical Writing on cross‑functional teams and guide document strategy
• Support disclosure activities (ClinicalTrials.gov, CTIS) and eSubmission‑ready publishing

What you bring:

• BA/BS with 12+ years of medical writing experience; advanced degree preferred
• Leadership experience with internal/external writing teams and major regulatory submissions
• Deep understanding of drug development, clinical research, and regulatory requirements
• Exceptional writing, data interpretation, and project management skills
• Strong collaboration and communication abilities

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