FSP Principal Medical writer (North America, embedded)

The Principal Medical Writer will research, write, and edit clinical study reports and protocols, summarizing data from clinical studies. They will serve as the primary author for complex clinical and scientific documents, including Investigator's Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs), and provide senior-level review of documents. Responsibilities include training and mentoring junior writers and program managers on document preparation, software use, document types, regulatory requirements, and therapeutic area knowledge. The role involves ensuring compliance with quality processes, developing and reviewing best practices, leading process improvement initiatives, and potentially managing performance metrics. Additionally, the Principal Medical Writer will represent the department in project meetings and collaborate with internal and external clients to ensure effective communication and operational excellence.