Associate Director, Medical Writing

Summit Therapeutics, Inc.

. 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 .

Posted 10/8/2026full-timeRemote • United StatesSenior💰 $10 - $20 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory medical writing, including the preparation and editing of clinical documents such as protocols and study reports. Proficient in managing timelines and collaborating across cross-functional teams to ensure compliance with regulatory guidelines.

Highest-signal resume keywords

Regulatory Medical WritingClinical Study ProtocolsClinical Study ReportsExcellent Writing SkillsMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Medical WritingClinical Study ProtocolsClinical Study ReportsInvestigator’s BrochuresIND SubmissionsNDA DocumentationDocument Review ManagementSOP DevelopmentAttention to DetailCritical Analysis

Soft Skills

Excellent Communication SkillsMultitaskingPrioritizationFlexibilityInitiative

Tools & Technologies

MS Office ApplicationsAdobe AcrobatElectronic Document Management SystemsTemplates

Industry Keywords

Pharmaceutical IndustryOncology Disease AreasDrug Development ProcessRegulatory GuidelinesCross-Functional Collaboration

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Potential bonus
Stock
Benefits and/or other applicable variable compensation