Principal Medical Writer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Principal Medical Writing - Make an Impact at the Forefront of Innovation
As a Principal Medical Writer, you will serve as the primary author by writing and providing input on routine documents including but not limited to clinical study reports, study protocols, M2 documents and summarizes data from clinical studies.


What You'll Do:
• Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
• As the lead writer, 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.
• Demonstrate subject matter and therapeutic area expertise.
• Act as backup program manager.
• Collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Education & Experience Requirements:
• Master's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
• Experience within regulatory medical writing (comparable to 8+ years) required
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.


Knowledge, Skills, Abilities:
• 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, communications, etc.
• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Excellent project management skills
• Advanced interpersonal, oral and written communication, and presentation skills
• Excellent negotiation skills
• Excellent judgment; high degree of independence in decision making and problem solving
• Ability to mentor and lead junior level staff.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.