Principal Medical Writer

As Principal Medical Writer, you lead the development of regulatory and clinical documents for global submissions, ensuring scientific clarity and regulatory compliance. You will work with a dedicated, single client in a fast-paced biotech context, shaping documents like CSRs, Clinical Summaries, and Clinical Overviews. You collaborate with cross-functional teams to align timelines and expectations, contributing to regulatory strategy and quality. This role offers meaningful impact in advancing clinical development within a diverse, high-performance environment.

• annual leave entitlements
• health insurance offerings
• retirement planning
• Global Employee Assistance Programme (EAP)
• life assurance
• flexible country-specific benefits

• Develop regulatory documents for global regulatory submissions (CSRs, Clinical Summaries, Clinical Overviews) per ICH and global guidelines and Incyte standards
• Manage medical writing projects including timelines and cross-functional communication to align review cycles
• Participate in cross-functional meetings to provide input on deliverables and processes
• Review related documents (e.g., Protocols, Statistical Analysis Plans) for assigned projects

• Bachelor's degree in life sciences; Master's preferred
• 6+ years medical writing experience in biopharmaceutical/CRO industry
• Regulatory writing experience (CSRs, IBs, Protocols)
• Proven writer with leadership in submissions; capable of multitasking across documents
• Oncology experience is a plus
• Strong knowledge of domestic and international regulatory requirements
• Proficient at organizing and communicating clinical information
• Excellent communications, organizational, time management, and project management skills

• strong communication
• organizational skills
• time management
• Regulatory writing
• Clinical Study Reports (CSRs)
• Investigator's Brochure (IB)