Job Title:
Principal Medical Writer – FSP (Remote, US)
Location: Remote – North Carolina, USA
Job Type: Full-time
Work Schedule: Standard (Mon-Fri)
Work Setting: Office / Remote
Company: Thermo Fisher Scientific (PPD Clinical Research Portfolio)
About the Role:
Thermo Fisher Scientific is expanding its Medical Writing Functional Service Partnership (FSP) Team. As a Principal/Senior Medical Writer, you will provide high-quality medical and scientific writing from planning through delivery of final drafts to internal and external clients. This role requires collaboration with stakeholders to ensure effective communication, operational excellence, and adherence to regulatory standards.
Therapeutic Focus: Infectious diseases and/or oncology
Key Responsibilities:
Serve as primary author for routine clinical documents (clinical study reports, study protocols) and summarize clinical data
Author complex clinical, scientific, and program-level documents, including Investigator’s Brochures (IBs), bioassay reports, INDs, and MAAs
Review and mentor early-career writers on document preparation, software use, regulatory requirements, and therapeutic area knowledge
Ensure compliance with quality processes and client-specific standards
Develop best practices and optimize methods for document development
Assist with program management activities, including timelines, budgets, forecasts, and contract modifications
Represent the department at project launch, review, and team meetings
Qualifications:
Education:
Bachelor’s degree in a scientific field (Advanced degree preferred)
Experience:
5+ years of relevant experience (pharmaceutical/CRO experience preferred)
Experience in client-dedicated roles or with 1–2 clients across multiple projects preferred
Additional qualifications in medical writing (AMWA, EMWA, RAC) advantageous
Combination of education, training, and relevant experience may also be considered
Skills & Competencies:
Excellent medical writing, data interpretation, grammatical, editorial, and proofreading skills
Strong project management and organizational skills
Excellent interpersonal, problem-solving, and negotiation skills
Strong oral and written communication and presentation skills
Significant knowledge of global, regional, and national regulatory document guidelines
In-depth expertise in preclinical or regulatory submissions
Sound judgment and decision-making skills
Proficiency in client templates, document management systems, and Microsoft Office (Excel, Outlook)
Work Environment:
Remote-based with office/virtual collaboration
Flexible working culture promoting work-life balance
Collaborative, global team environment with opportunities for professional growth
Benefits & Culture:
Competitive salary with award-winning learning and development programs
Comprehensive benefits package focusing on employee health and well-being
Collaborative environment fostering knowledge sharing, innovation, and fun
Opportunity to work in a global organization with local team feel
Core company values: Integrity, Intensity, Innovation, and Involvement
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