Director, Medical Writing
Core
Strategic leadership and hands-on execution for developing high-quality, compliant clinical and regulatory documents supporting drug development programs for neuromuscular diseases.
Role type
Director, Medical Writing
Builds
Clinical and regulatory submissions (protocols, CTD modules, CSRs) for FDA and global health authorities
Domain
Biotechnology / Neuromuscular diseases (DMD, DM1)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing strategy, clinical document authoring, regulatory compliance (FDA/ICH), vendor management, cross-functional leadership, scientific accuracy
Preferred skills
Advanced degree in life sciences, biochemistry/molecular biology expertise
Technologies
Microsoft Office, Adobe Acrobat, SharePoint
Responsibilities
Lead planning and authoring of clinical/regulatory documents; Manage internal and external writing resources; Author/edit protocols, CSRs, CTD modules; Establish and improve writing processes and templates; Contribute to cross-functional project planning
Seniority
Director, strategic leadership with hands-on execution
