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

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