Principal Medical Writer

We are seeking an experienced professional with advanced medical writing expertise who can independently manage complex regulatory writing projects. This role demands a deep understanding of clinical trial designs, statistical analysis interpretation, and clinical document processes.

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