Remote Senior Director, Medical Writing & Submissions

A biopharmaceutical company focused on rare diseases is seeking a Senior Director of Medical Writing to lead the development of high-quality clinical and regulatory documents across the drug lifecycle. The company is advancing late-stage programs for rare, serious conditions and preparing for future commercialization.

Key Responsibilities

• Lead strategy and delivery of clinical/regulatory documents (e.g., protocols, study reports, regulatory summaries)
• Manage external vendors and potentially build an internal medical writing team
• Oversee timelines, resources, and document quality/compliance (ICH/GCP/eCTD)
• Collaborate cross-functionally with R&D, regulatory, and data teams
• Drive process improvements, SOP development, and operational efficiency
• Ensure accurate, consistent, submission-ready documentation
• Support regulatory submissions and public disclosures (e.g., trial registries)

Qualifications

• Bachelor’s degree with 12+ years in medical writing (advanced degree preferred)
• Experience leading teams and managing external vendors
• Strong background in regulatory documents and drug development
• Knowledge of clinical research, biostatistics, and regulatory standards
• Excellent writing, data interpretation, and organizational skills
• Ability to manage multiple projects and meet tight deadlines

This role is remote in the US, East Coast strongly preferred