FSP Medical Writer (Regulatory)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Us as a Medical Writer - Make an Impact at the Forefront of Innovation

The Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

What You'll Do:

• 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.
• May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Ensure compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.
• May assist in program management activities. Duties could include assisting with developing timelines, budgets, and forecasts for assigned deliverables.

Represent the department at project launch meetings, review meetings, and project team meetings.

Education & Experience Requirements:

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Experience working in the pharmaceutical/CRO industry preferred
• Experience in scientific writing 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:

• Solid medical writing skills, including grammatical, editorial, and proofreading skills
• Ability to interpret and present complex data accurately and concisely
• Effective administrative, organizational and planning skills; attention to detail and quality

Ability to work on own initiative and effectively within a team

Effective oral and written communication skills

Good knowledge of regulatory documentation and drug development process

Great judgment and decision-making skills

Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Working Conditions and Environment:

• Work is performed in an office environment.
• Exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
• Long, varied hours required occasionally.
  
  

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.