Principal Medical Writer

Position Overview

• Location Type: Remote
• Employment Type: Full-time
• Salary: Not specified
• Summary: Thermo Fisher Scientific is expanding its Medical Writing FSP Team in India. We are seeking a Project Medical Writer dedicated to a client in the FSP space. The ideal candidate will have experience in Structured Content Authoring systems and automation to support delivery. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely.

Requirements

• Education: Bachelor’s degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred.
• Experience:
  • Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 8+ years in core Regulatory Medical Writer role capacity).
  • Experience working in the pharmaceutical/CRO industry required.
  • Experience in managing and directing complex medical writing projects required.
  • Extensive experience in Phase 3 CSRs and/or protocol development required.
  • EU CTR experience preferred.
  • Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation preferred.

Responsibilities

• Lead the development, writing, and editing of complex clinical and regulatory documents.
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure the accurate and timely completion of documents.
• Ensure documents align with regulatory guidelines, company standards, and industry best practices.
• Provide strategic input and guidance on document content, structure, and presentation.
• Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
• Manage multiple writing projects simultaneously and prioritize tasks effectively.
• Stay current with industry trends, guidelines, and regulatory requirements.

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner, and safer.
• Work Environment: Remote
• Global Reach: Clinical trials conducted in 100+ countries, ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio.