Senior Medical Writer (FSP)

Senior Medical Writer position at Thermo Fisher Scientific involving creation of clinical and scientific documentation, from study protocols and reports through regulatory submissions. The role requires collaboration with internal and external stakeholders to ensure compliance and operational excellence in medical affairs.

Responsibilities

• Author clinical study reports, protocols, and related scientific documents as primary writer
• Summarize clinical study data and ensure accurate, concise presentation of complex information
• Support development of regulatory submissions including IBs, INDs, and MAAs
• Represent department at project meetings and coordinate timelines and budgets for deliverables
• Maintain compliance with quality processes and contribute to best practices methodology

Requirements

• Bachelor's degree in scientific discipline or equivalent qualification
• 2+ years related experience in medical/scientific writing or pharmaceutical industry
• Proficiency in regulatory documentation and drug development processes
• Strong data interpretation, organizational, and communication skills
• Proficiency with document management systems, Excel, and standard office applications
• Experience in pharmaceutical or CRO sector preferred