Associate Director, Medical Writing

The role

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

What you will do

• Prepare, edit, and finalize clinical/regulatory documents including protocols, CSRs, Investigator’s Brochures, briefing documents, and Module 2 clinical summary documents
• Interact with document authors, contributors, and reviewers to acquire necessary input
• Manage the document review process
• Schedule and conduct meetings to ensure documentation timelines are achieved
• Manage medical writing timelines for assigned documents
• Facilitate comment resolution and adjudication with authors, reviewers, and project teams
• Participate in the refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides

Required qualifications

• BA/BS degree in a scientific field
• 8+ 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
• Excellent writing skills
• Good understanding of the drug development process and relevant regulatory guidelines
• Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
• Excellent attention to detail, multitasking, prioritization, and flexibility
• Excellent communication skills with proven ability to interact in a cross-functional environment
• Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
• Proficiency in use of MS Office applications, Adobe Acrobat, electronic document management systems, and templates
• Ability to think strategically, be resourceful, and lead with minimal direction

Nice to have

• advanced scientific degree (PhD, PharmD, or MS)
• Knowledge of oncology disease areas

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.