Principal Medical Writer (Remote – United States)
Location: Remote, North Carolina, United States
Job ID: R-01331907
Job Type: Full-Time
Category: Clinical Research
About the Role
Thermo Fisher Scientific is seeking an experienced Principal Medical Writer to join its expanding Medical Writing Functional Service Partnership (FSP) team. This fully remote position within the U.S. plays a critical role in developing high-quality clinical and regulatory documentation that supports global clinical research programs.
As a Principal Medical Writer, you will lead the preparation, review, and delivery of complex scientific and regulatory documents across multiple therapeutic areas, including infectious diseases and oncology. You will collaborate cross-functionally to ensure accuracy, compliance, and clarity while supporting scientific communication strategies for internal and external stakeholders.
Key Responsibilities
Serve as the primary author for clinical and scientific documents, including study protocols, clinical study reports (CSRs), Investigator’s Brochures (IBs), INDs, MAAs, and bioassay reports.
Summarize and interpret data from clinical and preclinical studies to prepare clear and accurate documentation.
Review documents created by junior medical writers and provide guidance, editorial support, and structured mentorship.
Ensure all deliverables meet regulatory standards, client-specific requirements, and internal quality benchmarks.
Contribute to developing best practices, writing methodologies, and document development processes.
Participate in project management activities, including timeline development, budget discussions, and scope assessments.
Represent the medical writing team during project kick-off sessions, review meetings, and sponsor communications.
Education and Experience Required
Bachelor’s degree in a scientific discipline required; advanced degree (Master’s or PhD) preferred.
Minimum 5 years of medical writing experience, preferably within the pharmaceutical or CRO industry.
Experience working in client-dedicated or multi-project environments within CRO settings is highly desirable.
Additional certifications in medical writing such as AMWA, EMWA, or RAC are advantageous.
Equivalent combinations of education, training, and directly relevant experience may be considered.
Skills and Competencies
Exceptional medical writing, data interpretation, grammar, and editorial skills.
Strong project management capabilities with the ability to manage multiple timelines.
Effective communication and presentation skills, with the ability to convey complex scientific concepts clearly.
Strong negotiation, problem-solving, and interpersonal skills.
Deep understanding of global regulatory guidelines and document development standards.
Advanced knowledge in specialized areas such as regulatory submissions or preclinical documentation.
Proficiency with document management systems, MS Office, and sponsor-required templates.
Work Environment
Fully remote role based within the United States.
Standard Monday–Friday work schedule.
Work performed in a virtual office environment with extended periods of computer use.
What We Offer
Thermo Fisher Scientific provides an excellent career environment focused on continual growth, collaboration, and innovation. Employees benefit from:
Competitive compensation aligned with experience.
Comprehensive health and wellness benefits.
Flexible working culture supporting work-life balance.
Access to award-winning learning and development programs.
Opportunities to engage with global teams and contribute to meaningful, life-changing scientific advancements.
As part of a global workforce of more than 100,000 professionals, you will contribute to our mission of supporting scientific breakthroughs that make the world healthier, cleaner, and safer.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Zaventem |South America :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Bangkok |Israel :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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