Freelance Medical Writer for Omnicom Health; focused on Medical Communications projects in Publications and Medical Affairs. Seeking advanced life sciences degree and significant medical writing experience.
About the role
- Principal Medical Writer at GSK handling regulatory submissions and authoring clinical documents. Leading document quality while managing complex writing projects in the pharmaceutical industry.
Responsibilities
- Author and deliver high‑quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions
- Lead and contribute to the planning, development, and delivery of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness
- Partner within cross‑functional, matrix teams to produce fit‑for‑purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements
- Manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs
- Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear, well‑structured regulatory narratives
- Review reporting and analysis plans, provide critical input on tables and data presentation, and 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
- Demonstrated ability to independently author complex regulatory documents and lead or significantly contribute to CTD submission dossiers, including Module 2 documents
- Strong understanding of clinical trial design, regulatory requirements, statistical concepts, and interpretation of clinical data
- Proven leadership capability with experience influencing and collaborating effectively in global, multicultural, and matrixed environments
- Working knowledge of ICH guidelines, Good Clinical Practice (GCP), and 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
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