Senior Regulatory Medical Writer, Client-embedded, FSP

Thermo Fisher Scientific seeks a Senior Regulatory Medical Writer for remote work in the US. The role involves authoring clinical and preclinical regulatory documents, collaborating with cross-functional teams, and mentoring junior writers to support regulatory submissions and communications.

Responsibilities Author clinical and preclinical regulatory documents including study protocols and clinical study reports Write complex regulatory submissions such as investigator's brochures and marketing authorization applications Collaborate with internal and external clients to gather information and ensure document accuracy Review and provide feedback on documents prepared by team members and junior writers Manage project timelines and deliverables while ensuring compliance with regulatory standards Requirements Bachelor's degree in scientific discipline; advanced degree preferred 5+ years experience in pharmaceutical or CRO regulatory writing Expertise in clinical regulatory documents (protocols, study reports, INDs, MAAs) Knowledge of global regulatory guidelines and document development standards Strong project management, communication, and interpersonal skills Proficiency with document management systems and Microsoft Office applications