Overview
We are seeking an experienced Senior Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and marketing authorization applications (MAAs/NDAs/BLAs) are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements.
The successful candidate will act as a lead writer for key summary documents, providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the Director of Medical Writing (or above)
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
Stay current with evolving global regulatory requirements, industry trends, and therapeutic area knowledge to ensure compliance and innovation
