Senior Regulatory Medical Writer, Client-embedded, FSP Job at Thermo Fisher Scientific, North Carolina

  • Thermo Fisher Scientific
  • North Carolina

Job Description

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

Job Tags

Work at office, Remote work

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