Principal Medical Writer / Senior Medical Writer

Roles & Responsibilities
• Research, write, and edit high-quality clinical and regulatory documents including clinical study reports, study protocols, and data summaries
• Act as primary author for complex clinical and program-level documents such as CSR, Protocol, ICF, IB, IND, and MAA
• Provide senior-level scientific and regulatory review of routine and complex medical writing deliverables
• Serve as lead writer, offering training, mentorship, and guidance to junior writers and cross-functional team members
• Advise internal and external stakeholders on document development strategy, regulatory expectations, and industry best practices
• Ensure compliance with quality standards, SOPs, and regulatory guidelines for all assigned documents
• Develop, review, and implement best practices, methodologies, and process improvement initiatives
• Manage and review performance metrics for assigned projects to ensure delivery excellence
• Support program management activities including timelines, forecasts, budgets, and identification of out-of-scope work
• Assist business development efforts through proposal content review, client presentations, and bid defense participation
• Represent the medical writing function in project launch meetings, review meetings, and cross-functional discussions

Qualification
• Bachelor’s degree in a scientific or life sciences discipline or equivalent qualification
• Advanced degree preferred

Experience
• Minimum 8+ years of regulatory medical writing experience
• Strong hands-on experience authoring CSR, Protocol, ICF, IB, and other regulatory documents
• Proven experience managing complex medical writing projects
• Prior experience in pharmaceutical or CRO environment required
• Submission document experience preferred
• Medical writing certifications (AMWA, EMWA, RAC) advantageous

Skills
• In-depth knowledge of global and regional regulatory document development guidelines
• Strong expertise in one or more specialty areas such as regulatory, submissions, therapeutic areas, or clinical development
• Excellent data interpretation, scientific writing, editing, and proofreading skills
• Strong project management and organizational capabilities
• Advanced written, verbal, and presentation communication skills
• Strong negotiation, decision-making, and problem-solving abilities
• Ability to work independently with high accountability
• Proven capability to mentor and lead junior medical writers

About the Company
Thermo Fisher Scientific, through its PPD® clinical research services, is a global leader in contract research supporting pharmaceutical and biotechnology organizations across all phases of clinical development. Operating in more than 100 countries, the organization delivers high-quality scientific, regulatory, and operational expertise to accelerate the development of life-changing therapies while upholding the highest standards of integrity, innovation, and collaboration.