Senior Manager, Medical Writing

Role Summary

We are seeking an experienced and motivated medical writer who is responsible for providing clinical and regulatory document support and advanced medical writing expertise to cross-functional teams, ensuring the successful and timely preparation of high-quality documents. This individual will also participate in the development and maintenance of document templates, style guides, and standard operating procedures to ensure consistency and quality across documents and will represent Medical Writing at various team meetings. This position reports to the Director of Medical Writing.

Key Responsibilities

• Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: protocols, investigator’s brochures, clinical study reports, briefing documents, Module 2 summary documents, and other clinical and regulatory documents.
• Communicates deliverables needed, writing process, and timelines to team members, and holds team members accountable to agreed-upon document milestones.
• Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals
• Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication.
• Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials.
• Oversees the planning, coordination, and execution of medical writing projects by external vendors and consultants to ensure milestones are met and resources are allocated efficiently.
• Leverages AI-enabled tools to enhance efficiency and quality of medical writing deliverables while maintaining scientific rigor and regulatory compliance.
• Helps define and implement best practices for the responsible use of AI within medical writing workflows.