Summit Therapeutics, Inc.
51 - 200 employees
Founded 2003
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.
Associate Director, Medical Writing
🕒 October 8
Where this job comes from
Posted on Summit Therapeutics, Inc.'s careers page, not through a job board
First seen by Remote Rocketship October 8
Still open on Summit Therapeutics, Inc.'s site. Checked 3 hours ago.
Summit Therapeutics, Inc.
51 - 200 employees
Founded 2003
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.
📋 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 • Interact with authors, contributors, and reviewers across Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs to obtain document input • Manage document review processes and schedules, and conduct meetings to achieve documentation timelines • Manage medical writing timelines for assigned documents and ensure on-time deliverables aligned with business needs • Facilitate comment resolution and adjudication with authors, reviewers, and project teams • Participate in refining medical writing processes, SOPs, work instructions, templates, and style and content guides
🎯 Requirements
• BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred • 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 higher-level summary documents • 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 with ability to interact in a cross-functional environment • Ability to critically analyze and synthesize complex scientific information from diverse scientific disciplines and clinical therapeutic areas • Proficiency in MS Office applications, Adobe Acrobat, electronic document management systems, and templates • Comfort working 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 • Knowledge of oncology disease areas preferred
🏖️ Benefits
• Potential bonus • Stock • Benefits and/or other applicable variable compensation
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