Thermo Fisher Scientific

Roles & Responsibilities
• Research, write, and edit clinical study documents including Clinical Study Reports (CSRs), study protocols, and related deliverables, summarising data from clinical studies
• Serve as primary author for complex clinical/scientific and program-level documents including IBs, INDs, and MAAs, as applicable
• Provide senior-level review of routine and complex documents, ensuring accuracy, completeness, and consistency
• Train, mentor, and guide junior writers and program managers on document preparation, regulatory requirements, software usage, and therapeutic area knowledge
• Ensure compliance with quality processes and document development standards for assigned projects
• Act as subject matter expert on document strategy, regulations, and industry best practices, and drive process improvement initiatives
• Develop/review best practices, methods, and techniques to optimise client-specific processes and delivery outcomes
• Support performance tracking by developing, reviewing, or managing project metrics where required
• Provide program support as needed, including identifying and resolving out-of-scope activities
• Contribute to timelines, budgets, forecasts, and contract modifications where applicable, and support business development (proposal text review, client presentations, bid defenses)
• Represent Medical Writing at project launch, review meetings, and cross-functional project team meetings

Qualification
• Bachelor’s degree in a scientific discipline or equivalent formal academic/vocational qualification
• Advanced degree preferred
• Additional certifications (AMWA, EMWA, RAC) advantageous

Experience
• 8+ years of regulatory medical writing experience
• Strong hands-on experience authoring CSRs, Protocols, ICFs, IB and other regulatory documents
• Proven experience managing and directing complex medical writing projects
• Pharmaceutical/CRO industry experience required
• Submissions document experience advantageous

Skills
• Regulatory document development expertise and strong knowledge of global/regional/national guidelines
• Excellent data interpretation, scientific writing, editing, and proofreading skills
• Strong document strategy and compliance mindset with quality process adherence
• Advanced project management skills including planning, timelines, and stakeholder coordination
• Strong interpersonal, written, oral, and presentation skills
• Negotiation skills and ability to handle scope management and issue resolution
• High independence, sound judgement, and structured problem solving
• Mentoring and leadership capability for junior staff development

About The Company
Thermo Fisher Scientific, through its PPD clinical research services portfolio, is a leading global CRO supporting drug development and clinical trials across 100+ countries. The organisation delivers scientific and clinical expertise across laboratory, digital, and decentralised trial services, with a mission to make the world healthier, cleaner, and safer through integrity, innovation, and collaboration.