Job Title: Principal Medical Writer
Location: Remote – India
Job ID: R-01316074
Employment Type: Full-Time
Category: Clinical Research
Work Mode: Fully Remote
About the Role
Thermo Fisher Scientific’s Clinical Research team, part of the global PPD® clinical research portfolio, is dedicated to advancing drug development to address challenging health issues worldwide. As a Principal Medical Writer (PMW) in the Functional Service Partnership (FSP) team based in India, you will play a key role in creating, reviewing, and managing complex clinical and regulatory documents.
This position requires expertise in scientific concepts, exceptional writing skills, and experience with Structured Content Authoring systems and automation to support high-quality, timely delivery.
Key Responsibilities
Lead the development, writing, and editing of complex clinical and regulatory documents.
Collaborate closely with cross-functional teams such as Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs to ensure accurate and timely document completion.
Ensure all documents comply with regulatory guidelines, company standards, and industry best practices.
Provide strategic input on document content, structure, and presentation.
Mentor and oversee junior medical writers to maintain high-quality deliverables.
Manage multiple writing projects simultaneously, prioritizing tasks effectively.
Stay updated with the latest industry trends, regulatory guidelines, and best practices.
Education & Experience
Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
Minimum of 8+ years of regulatory medical writing experience, ideally in the pharmaceutical or CRO industry.
Proven experience managing and directing complex medical writing projects.
Extensive experience with Phase 3 Clinical Study Reports (CSRs) and/or protocol development.
Experience with the European Union Clinical Trial Regulation (EU CTR) is preferred.
Familiarity with structured content management systems, AI-driven content creation, and Natural Language Generation technologies is highly desirable.
Skills & Competencies
Excellent organizational and program management skills.
Strong leadership ability to manage and mentor medical writing teams.
In-depth knowledge of regulatory guidelines and drug development processes.
Excellent interpersonal and communication skills for effective collaboration.
Understanding of quality control processes to ensure compliance.
Self-motivated, adaptable, and able to exercise independent judgment.
High attention to detail and commitment to delivering quality work.
What We Offer
Award-winning learning and development programs to support your professional growth.
Competitive salary and comprehensive benefits package focused on employee health and well-being.
Flexible work culture promoting work-life balance.
Collaborative, supportive, and inclusive global team environment.
Opportunity to contribute to meaningful work impacting health outcomes worldwide.
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science with annual revenues exceeding $40 billion. Our mission is to enable customers to make the world healthier, cleaner, and safer. We deliver innovative technologies and pharmaceutical services through industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Learn more at: www.thermofisher.com
Equal Opportunity & Accessibility
Thermo Fisher Scientific is an Equal Opportunity Employer committed to diversity and inclusion. We provide reasonable accommodations for individuals with disabilities throughout the application and employment process. Please contact us to request accommodations.
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