Principal Medical Writer – Remote (United States)
Job ID: R-01331907
Location: North Carolina, USA (Fully Remote)
Job Type: Full-Time
Category: Clinical Research
Overview
The Principal Medical Writer plays a critical role in advancing global clinical research by developing clear, accurate, and compliant scientific documents. This position supports the PPD® clinical research portfolio under Thermo Fisher Scientific, one of the world’s leading contract research organizations (CROs). The role is fully remote within the United States.
Thermo Fisher Scientific enables customers worldwide to make the world healthier, cleaner, and safer. With clinical studies conducted in over 100 countries, the organization supports the development of life-changing therapies through laboratory, digital, and decentralized trial services.
Position Summary
As a Senior Regulatory Medical Writer within the Functional Service Partnership (FSP) team, you will lead the development, planning, and delivery of high-quality medical and scientific documentation. This includes authoring both clinical and preclinical regulatory documents. Expertise in infectious diseases and oncology is preferred.
You will collaborate closely with internal and external stakeholders, ensuring clarity, regulatory compliance, and operational efficiency across all assigned projects.
Key Responsibilities
Serve as the primary author for clinical documentation, including clinical study reports, study protocols, and summaries of clinical study data.
Lead development of complex regulatory and scientific documents such as Investigator’s Brochures (IBs), IND applications, bioassay reports, and Marketing Authorization Applications (MAAs).
Review and provide quality oversight on documents authored by junior writers.
Offer training and mentoring on document development, regulatory requirements, and therapeutic areas.
Ensure strict compliance with internal quality processes and regulatory guidelines.
Contribute to program management tasks, including budgeting, timeline planning, forecasting, and change management.
Participate in project launch meetings, document review meetings, and cross-functional discussions.
Support continuous improvement by developing best practices and optimized writing methodologies.
Education and Experience Requirements
Bachelor’s degree in a scientific discipline required; an advanced degree is preferred.
Minimum 5+ years of medical writing experience in clinical research or pharmaceutical/CRO settings.
Experience working in a client-dedicated CRO model is an advantage.
Additional certifications (AMWA, EMWA, RAC) are considered beneficial.
Equivalent combinations of education, training, or directly relevant experience may be accepted.
Skills and Competencies
Exceptional medical and scientific writing ability, with strong editorial and data interpretation skills.
Deep understanding of global and regional regulatory requirements.
Advanced knowledge in regulatory submissions or preclinical documentation.
Strong project management and organizational abilities.
Excellent communication, presentation, negotiation, and problem-solving skills.
Proficiency in using document management systems, MS Office applications, and client-specific templates.
Ability to work independently within complex, fast-paced clinical research environments.
Work Environment and Benefits
Thermo Fisher Scientific promotes a balanced and supportive remote work culture. Employees benefit from:
Competitive compensation
Comprehensive health and wellness programs
Award-winning learning and development resources
Opportunities for professional growth within a global organization
Collaborative work environment with access to cross-functional expertise
As part of a global team of more than 100,000 professionals, you will contribute to accelerating research, advancing scientific innovation, and supporting patients worldwide.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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