[Hiring] Principal Medical Writer @Thermo Fisher Scientific

Role Description

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer.

We are excited to expand our Medical Writing FSP Team in Europe. This would be a remote role. We are looking for a Principal Medical Writer to be dedicated to a client in the FSP space; experience in Neurology, Immunology, Oncology or Vaccines would be valuable but not essential.

As a Principal Medical Writer you will:

• Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
• Review documents for the team and provide training and guidance to junior team members.
• Provide advice on document development strategy, regulations, and industry best practices.
• Collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Qualifications

• 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 8+ years).
• Experience in managing and directing complex medical writing projects required.
• 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.

Requirements

• Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.
• May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Provides senior level review of routine and complex documents.
• Provides training and mentorship for other 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.
• Develops and reviews best practices, methods, and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives.
• May also develop, review, and manage performance metrics for assigned projects.
• Represents the department at project launch meetings, review meetings, and project team meetings.

Benefits

• Award-winning learning and development programme.
• Competitive salary.
• Extensive benefits package focused on health and well-being of employees.
• Flexible working culture promoting work-life balance.
• Collaborative environment with teams eager to share expertise and have fun together.