Principal Medical Writer leading CMC regulatory submissions for Veristat’s life - sciences clients. Authoring Modules 3 and 2.3 while guiding project teams and mentoring regulatory writers.
About the role
- Principal Medical Writer authoring complex clinical regulatory documents for GSK, a global biopharma company developing medicines and vaccines. Leading CTD submissions and translating clinical and statistical data into clear regulatory narratives.
Responsibilities
- Author and deliver high-quality clinical regulatory documents, including protocols, Clinical Study Reports, Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions
- Lead and contribute to planning, development, and delivery of clinical dossier documents for global regulatory submissions
- Ensure quality, consistency, and timeliness of regulatory documents
- Partner within cross-functional, matrix teams to produce fit-for-purpose documents reflecting clinical and statistical data and complying with GSK standards and regulatory requirements
- Manage complex writing projects and coordinate multiple contributors
- Adapt plans to evolving priorities, therapeutic areas, and submission needs
- Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear regulatory narratives
- Review reporting and analysis plans
- Provide critical input on tables and data presentation
- Apply efficient document development approaches, including review tools and automation
Requirements
- PhD or equivalent relevant experience within the life sciences
- Advanced experience in clinical regulatory medical writing within the pharmaceutical industry
- Ability to independently author complex regulatory documents
- Experience leading or significantly contributing to CTD submission dossiers, including Module 2 documents
- Strong understanding of clinical trial design, regulatory requirements, statistical concepts, and clinical data interpretation
- Proven leadership capability in global, multicultural, and matrixed environments
- Working knowledge of ICH guidelines and Good Clinical Practice (GCP)
- Strong written and verbal English communication skills
Benefits
- Competitive salary
- Annual bonus based on company performance
- Healthcare and wellbeing programmes
- Pension plan membership
- Shares and savings programme
- Hybrid working model balancing remote and in-office work
- Agile working culture and flexibility
- Recruitment process adjustments available
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