Senior Medical Writer, Promotional Review

Thermo Fisher Scientific seeks a Senior Medical Writer to author clinical and regulatory documents, mentor junior staff, and support program management activities. The role requires scientific writing expertise, regulatory knowledge, and collaboration with internal and external stakeholders in a remote California position.

Responsibilities

• Author clinical study reports, protocols, and regulatory submissions (IBs, INDs, MAAs)
• Review and provide feedback on documents prepared by junior team members and trainees
• Mentor junior writers on regulatory requirements, therapeutic area knowledge, and best practices
• Ensure compliance with quality processes and develop standardized methods for document preparation
• Participate in project meetings, timelines development, and program management support activities

Requirements

• Bachelor's degree in scientific discipline or equivalent; advanced degree preferred
• 5+ years of related experience in medical writing and document development
• Pharmaceutical or CRO industry experience preferred
• Professional qualifications (AMWA, EMWA, or RAC) advantageous
• Strong data interpretation, editing, and proofreading skills
• Knowledge of global regulatory guidelines and document development standards
• Proficiency with document management systems and Microsoft Office applications

Compensation: $115,000–$125,000 base