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Medical Writer and Regulatory Specialist
2 months ago
We are seeking a talented Medical Writer and Regulatory Specialist to join our team at Thermo Fisher Scientific. As a key member of our team, you will play a crucial role in delivering high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
About the RoleThis is a remote opportunity working from Canada on the EST timezone. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Key Responsibilities- Serves as primary author for an FSP client who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- Maintains up-to-date knowledge of global, regional, national, and other document development guidelines.
- Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods, and techniques for achieving optimal results, including various client specific processes.
- 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 of regulatory writing).
- Experience working in the pharmaceutical/CRO industry preferred.
- Experience working within FSPs preferable.
At Thermo Fisher Scientific, we offer a competitive salary range of $120,000 - $150,000 per annum, based on experience. Additionally, we have an extensive benefits package based around the health and well-being of our employees. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
