Principal Medical Writer - FSP

Salary

Core Qualifications

Key Responsibilities

• •Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submissions) in compliance with global regulatory guidelines (ICH, FDA, EMA) and internal standards
• •Serve as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs
• •Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning to ensure alignment with program goals
• •Manage medical writing projects, including planning, timelines, resource coordination, and delivery to ensure milestones and submission deadlines are met
• •Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety, etc.) to gather, interpret, and accurately present clinical data
• •Mentor and support other medical writers, ensuring high-quality, scientifically sound, and consistent deliverables across projects
• •Review and edit project-related documents to ensure accuracy, clarity, consistency, and compliance with templates and style guides
• •Attend project and team meetings to provide expert input on document development, study data interpretation, and process improvements
• •Contribute to and lead process improvement initiatives to enhance efficiency, quality, and consistency in document preparation
• •Develop, maintain, and refine standard operating procedures (SOPs), templates, and best practices for medical writing