Principal Medical Writer

Overview

In this role you drive high-quality regulatory and clinical documents, leading writing workstreams and cross-functional collaboration to support major submissions. You guide best practices, mentor junior writers, and stay aligned with evolving regulatory standards. You act as the lead writer on complex projects, shaping regulatory submissions for biologics and drugs.

This position combines leadership with hands-on writing to ensure timely, compliant outcomes.

• competitive base salary; performance incentives
• health and wellbeing programmes (medical, dental, vision)
• retirement and pension plans
• life assurance and disability coverage
• employee assistance programmes and wellbeing resources
• learning and development opportunities

• Oversee medical writing workstreams and ensure deliverables meet quality and timelines
• Lead preparation and review of clinical study reports, protocols, and regulatory documents for accuracy and clarity
• Collaborate with clinical research, biostatistics, and regulatory affairs to gather and synthesize information
• Provide guidance on best practices and regulatory requirements; uphold internal standards
• Mentor and train junior medical writers to foster excellence and growth
• Stay current with industry trends and regulatory guidelines to inform writing
• Act as lead medical writer for complex projects and manage regulatory submission writing for major biologics and drugs
• Perform all duties of Senior Medical Writer and lead regulatory submission writing when required

• Bachelor's degree in life sciences, pharmacy, or related discipline
• Significant medical writing experience with regulatory submissions and clinical documentation
• Strong understanding of regulatory requirements and industry standards for clinical writing
• Exceptional writing and editing skills with attention to detail
• ≥5 years in pharma/biotechnology writing; 3+ years in electronic documents and submissions
• Experience with key documents in major international regulatory submissions (CSR, IBs, Protocols)
• Experience managing writing activities for major international regulatory submissions

• excellent written and verbal communication
• mentoring and leadership
• cross-functional collaboration
• regulatory writing for clinical and regulatory submissions
• clinical study reports (CSRs)
• investigator's brochures (IBs)