Sr Director, Medical Writing
Core
Lead strategic planning and drafting of complex regulatory submissions and clinical documents for business-critical projects in virology, oncology, and inflammation.
Role type
Senior Director, Medical Writing (Regulatory Affairs)
Builds
High-quality regulatory submissions and clinical/regulatory documents for global patient access
Domain
Biopharmaceuticals, Regulatory Affairs, Medical Writing
Required skills
Strategic planning, Cross-functional team leadership, Regulatory document strategy, Therapeutic area expertise, Process improvement, Talent management
Preferred skills
Advanced degree in life sciences, Experience managing external contractors
Technologies
Regulatory submission templates, Clinical data science tools
Responsibilities
Lead and manage a team of direct reports and external contractors; Oversee strategic planning and drafting of complex submissions; Guide all deliverables and activities of the assigned team; Communicate regulatory changes and develop cross-functional training programs; Lead special projects and represent the CSD function in cross-functional initiatives; Act as subject matter expert for clinical/regulatory documents.
Seniority
Senior Director, strategic leadership & team management