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