FSP Senior Medical Writer

The Senior Medical Writer will serve as the primary author for FSP clients, writing and providing input on routine documents such as clinical study reports and protocols, and summarizing clinical study data. They may also research, write, or edit complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs. Responsibilities include reviewing documents prepared by junior team members, potentially providing training and mentorship on document preparation, software use, document types, regulatory requirements, and therapeutic area knowledge. The role involves ensuring compliance with quality processes, developing best practices for optimal results, and potentially assisting in program management activities like developing timelines, budgets, forecasts, and contract modifications. The Senior Medical Writer will also represent the department at various project meetings.