Director, Medical Writing

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $190k - $237k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• 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