Director, Medical Writing
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Job Description
Medical Writing Director developing clinical and regulatory documents for Summit Therapeutics’ oncology programs. Leading document reviews, timelines, and cross-functional regulatory submissions.
Responsibilities:
- Prepare, edit, and finalize clinical and regulatory documents, including protocols and amendments, clinical study reports, Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions
- Collaborate with document authors, contributors, and reviewers across Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs
- Manage document review processes and schedules, and conduct meetings to achieve documentation timelines
- Develop and manage medical writing timelines for assigned documents and ensure on-time deliverables
- Facilitate comment resolution and adjudication with authors, reviewers, and project teams
- Participate in developing and refining medical writing processes, SOPs, work instructions, templates, and style and content guides
- Perform other duties as assigned
Requirements:
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
- 10+ years of regulatory medical writing experience in the pharmaceutical industry or an organization serving them
- Experience writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of IND submissions and NDAs
- Understanding of the content of higher-level summary documents
- Knowledge of oncology disease areas preferred
- Excellent writing skills and understanding of the drug development process and relevant regulatory guidelines
- Ability to write and edit complex material for accuracy, clarity, consistency, and effectiveness
- Excellent attention to detail, multitasking, prioritization, and flexibility
- Excellent communication skills and ability to interact in a cross-functional environment
- Ability to critically analyze and synthesize complex scientific information from varied scientific disciplines and clinical therapeutic areas
- Proficiency with MS Office applications, Adobe Acrobat, electronic document management systems, and templates
- Comfortable in a fast-paced small company environment with minimal direction and changing priorities
- Demonstrated initiative and ability to manage multiple projects simultaneously with minimal direction
- Ability to think strategically, be resourceful, and lead with minimal direction
Benefits:
- Potential bonus
- Stock
- Benefits
- Other applicable variable compensation
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