Senior Medical Writer
hace 4 semanas
Senior Medical Writer (EMEA) - Clinical Trials Expert
At Thermo Fisher Scientific, we are committed to enabling our customers to make a positive impact on a global scale. As a Senior Medical Writer (EMEA) - Clinical Trials Expert, you will be part of our team that brings our Mission to life. Our work spans laboratory, digital, and decentralized clinical trial services, with clinical trials conducted in 100+ countries.
Key Responsibilities:
- Serves as primary author for FSP clients who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- 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.
- May assist in program management activities. Identifies and resolves out of scope activities. Duties could include 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).
- Experience working in the pharmaceutical / CRO industry preferred. Experience working within FSPs preferable.
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
About Us:
Thermo Fisher Scientific is a leading provider of scientific instrumentation, software, and services. We are committed to enabling our customers to make a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. We are excited to expand our Medical Writing FSP Team in EMEA and are looking for a Senior Medical Writer to be dedicated to a client in the FSP space; experience in Immunology, Oncology or Vaccines would be valuable but not essential.
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