Senior Medical Writer – Regulatory

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Lead ambitious initiatives that craft the future of clinical research • Deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, and Investigator Brochures • Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies • Review routine documents prepared by junior team members and may provide training and mentorship for junior writers • Ensure compliance with quality processes and requirements for assigned documents • Provide input on and independently develop best practices, methods and techniques for achieving optimal results • Assist in program management activities including developing timelines, budgets, forecasts and contract modifications

🎯 Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills • Strong project management skills • Significant knowledge of global, regional, national and other document development guidelines • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. • Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

🏖️ Benefits

• competitive remuneration • annual incentive plan bonus • healthcare • a range of employee benefits • flexible working culture • work-life balance