Senior Medical Writer

Overview

You will lead the development of regulatory and clinical documents to support global submissions. You’ll guide writing strategy, timelines, and cross‑functional coordination to ensure compliant, high‑quality content. You work with cross‑functional teams on international regulatory guidance and content standards. This role offers senior visibility and influence in regulatory strategy and document production, within a mission‑driven, inclusive environment.

Pay / Benefits

• competitive salary
• annual leave entitlements
• health insurance
• retirement planning
• Employee Assistance Programme
• life assurance

Responsibilities

• Guide medical writing document preparation and coordinate assignment, review, and substantive editing
• Lead preparation of key regulatory response documents and major regulatory submissions
• Formulate writing strategy, timelines, and resource planning for documents and submissions
• Participate on project teams, providing cross-functional guidance on content, format, and processes
• Lead writing strategy and provide advanced input on study designs, analysis plans, and sections of INDs/marketing applications
• Review and edit contributions, resolving issues and ensuring regulatory and sponsor adherence
• Manage deliverables and document preparation for regulatory submissions within therapeutic areas
• Represent Medical Writing on cross-functional teams and act as Medical Writing point of contact for regulatory strategy
• Serve as lead writer for important regulatory response documents and components of submissions
• Provide leadership on functional teams addressing document preparation and production

Key requirements

• Bachelor’s degree in science or health profession
• 5+ years of pharma/biotech medical writing experience
• 3+ years of experience with electronic documents and submissions
• Experience with Clinical Study Reports, IBs, Protocols
• Experience managing writing activities for major international regulatory submissions (preferred)

• clear written and oral communication
• problem-solving
• interpersonal collaboration
• clinical development knowledge
• ICH guidelines and international regulatory processes
• content and format standards for regulatory documents

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