Senior Medical Writer (Medtech)

TL;DR

Senior Medical Writer (Medtech): Leading the development of high-quality clinical study documentation with an accent on regulatory compliance and data accuracy. Focus on authoring complex clinical documents, including protocols and CSRs, while ensuring seamless document management across cross-functional teams.

Location: Must be based in the United Kingdom

Company

A global organization specializing in clinical research and medical development services.

What you will do

• Plan, write, edit, and perform QC reviews for clinical study protocols, IBs, ICF templates, DSURs, and CSRs.
• Manage the full document lifecycle from template creation to final approval in collaboration with sponsors and internal teams.
• Independently formulate key messages from clinical study data.
• Author complex content while adhering to regulatory guidelines and internal SOPs.
• Conduct literature-based research to support writing activities.
• Contribute to the development and maintenance of medical writing processes and templates.

Requirements

• Must be based in the United Kingdom
• BS degree or equivalent in a scientific or medical discipline.
• 5+ years of experience as a Senior Medical Writer in a sponsor or CRO setting (or 7+ years for Principal level).
• Clear understanding of ICH, FDA, GCP, and eCTD regulatory requirements.
• Proficiency with Microsoft Office suite and Adobe Acrobat.
• Ability to work effectively in a fast-paced environment with multiple high-priority projects.

Nice to have

• Advanced degree (MS or PhD).
• Experience in oncology or rare disease therapeutic areas.

Culture & Benefits

• Opportunity to work on high-impact clinical development projects.
• Collaborative environment working with internal project teams and external sponsors.
• Focus on professional development and process improvement within medical writing.