Director, Medical Writing

The Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.

Role And Responsibilities

• Prepare, edit, and finalize clinical / regulatory documents, including protocols / protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed
• Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
• Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
• Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
• Facilitate comment resolution and adjudication with authors, reviewers, and project teams
• Participate in the development / refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high- quality medical writing deliverables
• All other duties as assigned

Experience, Education And Specialized Knowledge And Skills

The pay range for this role is $200,000-$235,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.

Summit is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to creating a diverse and inclusive workplace and encourage applications from underrepresented groups.

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