Principal / Senior Medical Writer – Remote, India (APAC)
Job ID: R-01334578
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Work Mode: Fully Remote
About the Role
Thermo Fisher Scientific is seeking an experienced Principal Medical Writer to join our Medical Writing Functional Service Provider (FSP) team in APAC. This fully remote role allows you to collaborate with global clients and cross-functional teams to deliver high-quality, regulatory-compliant clinical documents. While experience in Immunology, Oncology, or Vaccines is valuable, candidates with broad therapeutic expertise are encouraged to apply.
As a Principal Medical Writer, you will serve as a subject matter expert, providing leadership and guidance to junior writers while ensuring the delivery of clinical study reports (CSRs), protocols, Investigator Brochures (IBs), informed consent forms (ICFs), and regulatory submissions with accuracy, clarity, and compliance. You will also advise on document strategy, regulatory requirements, and industry best practices.
Key Responsibilities
Author, review, and edit complex clinical and regulatory documents, including CSRs, protocols, ICFs, IBs, INDs, and MAAs.
Serve as the primary author or reviewer for program-level documents and provide oversight of junior writers’ outputs.
Mentor, train, and guide junior medical writers and project managers on document preparation, regulatory requirements, and therapeutic knowledge.
Ensure compliance with global, regional, and client-specific quality processes and timelines.
Develop and implement best practices, methods, and techniques for document preparation and review.
Support program management activities, including timeline planning, budget monitoring, forecasts, contract modifications, and client presentations.
Represent the medical writing team at project kick-off, review, and team meetings, serving as a key liaison for internal and external stakeholders.
Contribute to process improvement initiatives and performance metrics for medical writing deliverables.
Education & Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline; Advanced degree preferred
8+ years of experience in regulatory medical writing within pharmaceutical or CRO settings
Proven experience in authoring and reviewing CSRs, protocols, ICFs, IBs, and other regulatory documents
Demonstrated experience in managing and directing complex medical writing projects
Submission document experience (IND, NDA, MAA) is highly advantageous
Additional medical writing certifications (AMWA, EMWA, RAC) are a plus
Knowledge, Skills & Competencies
In-depth knowledge of global, regional, and national document development guidelines
Expertise in preclinical, therapeutic, regulatory, submissions, or communications areas
Strong data interpretation and scientific writing skills with meticulous attention to grammar, editorial quality, and consistency
Advanced project management skills, including budgeting, timeline management, and workflow optimization
Exceptional interpersonal, communication, presentation, and negotiation skills
Proven ability to mentor and lead junior-level staff while fostering a collaborative team environment
Excellent judgment and independent problem-solving skills
Why Join Thermo Fisher Scientific
Global Impact: Work on clinical research that supports life-changing therapies worldwide
Career Growth: Participate in advanced FSP projects, with tailored learning pathways, mentorship, and opportunities to progress along the medical writing or program management career tracks
Innovative Environment: Collaborate with global teams on novel frameworks for clinical research, including digital and decentralized trial services
Flexible Work Culture: Enjoy remote work, work-life balance, and professional development programs
Diverse & Inclusive Workplace: Be part of a global team that values integrity, innovation, intensity, and involvement
Thermo Fisher Scientific is a world leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Join over 100,000 colleagues globally in a collaborative environment that values diverse experiences, backgrounds, and perspectives.
Learn more at www.thermofisher.com. Thermo Fisher Scientific is an Equal Opportunity Employer.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Bangkok |Israel :
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Prague |Chile :
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