Thermo Fisher Scientific
10,000+ employees
🧬 Biotechnology
💊 Pharmaceuticals
🏥 Healthcare
Biotechnology • Pharmaceuticals • Healthcare
Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.
Principal Medical Writer – Regulatory
🔥 6 minutes ago
Where this job comes from
Posted on Thermo Fisher Scientific's careers page, not through a job board
First seen by Remote Rocketship 6 minutes ago
Thermo Fisher Scientific
10,000+ employees
🧬 Biotechnology
💊 Pharmaceuticals
🏥 Healthcare
Biotechnology • Pharmaceuticals • Healthcare
Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.
📋 Description
• Research, write, and edit clinical study reports and study protocols • Summarize data from clinical studies • Serve as primary author for complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs • Provide senior-level review of routine and complex documents • Train and mentor writers and program managers on document preparation, document-development software, document types, regulatory requirements, and therapeutic-area knowledge • Ensure compliance with quality processes and requirements for assigned documents • Develop and review best practices, methods, and techniques for optimal results, including client-specific processes • Lead process-improvement initiatives • Develop, review, and manage performance metrics for assigned projects • Represent the department at project-launch, review, and project-team meetings • Provide advice on document-development strategy, regulations, and industry best practices • Collaborate with internal and external clients to support effective and efficient communication and operational excellence
🎯 Requirements
• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification • Advanced degree preferred • 8+ years of relevant experience • Experience managing and directing complex medical writing projects • Experience working in the pharmaceutical/CRO industry preferred • Submissions document experience advantageous • Experience in Neurosciences advantageous • Additional qualifications in medical writing (AMWA, EMWA, RAC) advantageous • Significant knowledge of global, regional, national, and other document development guidelines • In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, or communications • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills • Excellent project management skills • Advanced interpersonal, oral, written communication, and presentation skills • Excellent negotiation skills • Excellent judgment and independent decision-making/problem-solving ability • Ability to mentor and lead junior-level staff
🏖️ Benefits
• Award-winning learning and development programme • Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Collaborative environment • Opportunities to share expertise and professional development • Global organization with a local feel
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