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Principal Medical Writer

5+ years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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