Senior Medical Writer

Regeneron

Senior Medical Writer authoring clinical study reports and regulatory documents for biotechnology company. Working remotely in a role requiring biostatistics knowledge and clinical writing expertise.

Posted 7/15/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $128,600 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical writing, including the development of clinical study reports, protocols, and informed consent forms, while adhering to regulatory guidelines and fostering collaboration among teams. Possesses strong organizational and communication skills to manage multiple projects effectively.

Highest-signal resume keywords

Clinical Writing ExperienceKnowledge of ICH GCPBiostatistics UnderstandingMS Word ProficiencyDocument Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ReportsProtocolsInformed Consent FormsStatistical Analysis PlansEditing ExperiencePlain-Language Content WritingRegulatory Document DevelopmentProcess ImprovementContent SynthesisMedical Concept Explanation

Soft Skills

Organizational SkillsInterpersonal SkillsCommunication SkillsMentoringConflict Resolution

Tools & Technologies

Adobe AcrobatPowerPointElectronic Document Management Systems

Industry Keywords

Clinical Research ProcessRegulatory GuidelinesSOPsTherapeutic AreasMedical Writing

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Author clinical study reports (CSRs), protocols, informed consent forms (ICFs), narratives, investigator brochures, and other regulatory documents across therapeutic areas
Represent Medical Writing at meetings, drive document development, and articulate strategy and timelines
Identify the right parties for content decisions and synthesise discussions into clear, accurate prose
Review work of junior or outsourced writers and CSR-related documents like Statistical Analysis Plans and TFLs
Write plain-language content such as ICFs and explain complex medical concepts to lay audiences
Adhere to applicable guidelines, templates, SOPs, and internal training while contributing to process improvement across Medical Writing and Global Development
Mentor junior staff, manage multiple priorities, and foster collaboration to resolve conflict

Requirements

What you’ll need

Bachelor's degree required; advanced degree preferred
Minimum 3 years of medical writing experience, including working knowledge of biostatistics
Strong knowledge of the clinical research process and applicable regulations, including ICH GCP
Clinical document reading, writing, and editing experience
Strong knowledge of MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems
Ability to manage multiple projects with strong organisational, interpersonal, and communication skills

Benefits

Comp & perks

annual bonuses or other incentive plans
equity awards
pension or retirement benefits
401(k) company match
health and wellness programs
fitness centers
insurance benefits (e.g. medical, dental, vision, life and disability)
paid time off
family support benefits