Document Review Specialist II – Medical Writing
Location: Bangalore, Karnataka, India (Fully Remote)
Job ID: R-01342111
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Work Schedule: Monday to Friday
Company Overview
Thermo Fisher Scientific is a global leader in scientific research and clinical development services. Through its PPD clinical research portfolio, the organization operates as a leading Contract Research Organization (CRO), delivering laboratory, digital, and decentralized clinical trial solutions across 100+ countries. The company partners with biopharmaceutical organizations to accelerate the development and delivery of life-changing therapies worldwide.
About the Role
We are hiring an experienced Document Review Specialist II – Medical Writing to join the expanding Medical Writing Functional Service Partnership (FSP) team. This is a fully remote opportunity based in India, dedicated to supporting one or more global clients within the pharmaceutical and CRO space.
The ideal candidate will bring strong expertise in reviewing regulatory and clinical documents, ensuring compliance with global regulatory standards, client templates, and editorial guidelines. This role demands exceptional attention to detail, advanced English proficiency, and a solid understanding of regulatory documentation within clinical research.
Key Responsibilities
Review highly technical scientific and regulatory documents for quality, accuracy, and compliance.
Validate scientific data in tables, listings, and figures against source documents.
Ensure consistency with global regulatory guidelines (ICH, FDA, and other international standards).
Edit documents for grammar, clarity, scientific accuracy, and audience appropriateness.
Review and support preparation of key clinical documents including:
Clinical Study Reports (CSRs)
Study Protocols and Amendments
Investigator’s Brochures (IBs)
Informed Consent Forms (ICFs)
Regulatory submission documents
Patient safety narratives
Apply and maintain knowledge of document templates, style guides, and regulatory frameworks.
Collaborate with cross-functional and geographically dispersed teams.
Manage priority reviews and adhere to tight timelines.
Required Experience
Minimum 2+ years of experience reviewing regulatory documents (CSR, Protocol, ICF, IB, and related documentation).
Experience in the pharmaceutical, biotechnology, or CRO industry preferred.
Experience working in a client-dedicated or multi-client FSP model is advantageous.
Practical experience with document management systems and Microsoft Word formatting for template compliance.
Educational Qualifications
Bachelor’s degree or equivalent academic/vocational qualification in Life Sciences, Pharmacy, Medicine, or a related discipline.
Core Skills & Competencies
Strong understanding of medical writing methodologies and clinical documentation standards.
Working knowledge of medical terminology, statistical concepts, Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements.
Advanced written and verbal communication skills in English.
Excellent analytical and quality review capabilities.
Strong organizational and time-management skills.
Ability to work independently and collaboratively in cross-cultural global teams.
High proficiency in document management systems and digital tools.
Why Join?
Fully remote working opportunity with global exposure.
Structured learning and development programs.
Competitive compensation and comprehensive benefits package.
Opportunity to work on global clinical trials across multiple therapeutic areas.
Collaborative and innovation-driven work culture.
SEO & GEO Keywords: Document Review Specialist, Medical Writing Jobs in Bangalore, Remote Clinical Research Jobs India, Regulatory Document Review, CSR Review Specialist, CRO Jobs India, Clinical Study Reports, ICH GCP Compliance, Pharmaceutical Medical Writing Careers.
For professionals seeking remote clinical research careers in medical writing and regulatory document review, this role offers an opportunity to contribute to global drug development programs while working within a high-performance, client-dedicated FSP model.
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