Document Review Specialist II – Medical Writing
Company: Thermo Fisher Scientific
Location: Bangalore, India (Remote)
Job Type: Full-Time | Fully Remote
Experience: 2+ Years
Qualification: Bachelor’s Degree or equivalent in relevant field
Salary Range: Not Specified
Job Overview
Thermo Fisher Scientific is hiring a Document Review Specialist II – Medical Writing to support regulatory document review within its Clinical Research (PPD) division.
The role involves reviewing and editing complex scientific and regulatory documents to ensure quality, accuracy, and compliance with client requirements, templates, and global regulatory standards. The specialist will work in a Functional Service Partnership (FSP) model, collaborating with internal teams and clients to deliver high-quality clinical documentation across the drug development lifecycle.
This position requires strong attention to detail, proficiency in English communication, and a solid understanding of regulatory documentation, ensuring consistency, clarity, and scientific integrity in all deliverables.
Key Responsibilities
Document Review & Quality Control
Review highly technical scientific and regulatory documents for quality and accuracy.
Ensure compliance with client templates, editorial standards, and regulatory guidelines.
Verify scientific consistency across tables, listings, figures, and source documents.
Edit documents for clarity, grammar, and consistency.
Scientific Validation & Accuracy
Validate scientific logic and ensure correctness of data presentation.
Cross-check document content against source data and regulatory expectations.
Ensure alignment with current industry standards and guidelines.
Editing & Content Enhancement
Refine scientific language for clarity, flow, and audience appropriateness.
Ensure consistency in terminology, formatting, and messaging.
Maintain high editorial standards across all documents.
Stakeholder Collaboration
Communicate with authors to resolve discrepancies and improve document quality.
Support internal teams to ensure effective communication and timely delivery.
Collaborate with cross-functional teams in a global environment.
Process Adherence & Flexibility
Adjust schedules to accommodate urgent review requests.
Maintain knowledge of evolving regulatory guidelines and templates.
Ensure adherence to SOPs, client requirements, and industry standards.
Required Skills
Medical Writing & Documentation
Strong understanding of regulatory documents such as CSR, Protocols, ICF, IB.
Knowledge of medical writing principles and document review processes.
Ability to ensure clarity, consistency, and scientific accuracy.
Regulatory & Compliance Knowledge
Understanding of GCP, ICH guidelines, and global regulatory requirements.
Familiarity with FDA and international regulatory standards.
Knowledge of document management systems and compliance processes.
Analytical & Attention to Detail
Strong analytical and critical thinking skills.
High attention to detail in reviewing complex scientific content.
Ability to identify inconsistencies and improve document quality.
Communication & Collaboration
Strong written and verbal communication skills.
Ability to work effectively in cross-functional and global teams.
Good interpersonal skills for stakeholder interaction.
Technical Skills
Proficiency in Microsoft Word and document formatting.
Knowledge of document management systems.
Advanced computer literacy.
Preferred Qualifications
Experience in pharmaceutical or CRO industry.
Experience working in client-dedicated roles or multi-project environments.
Experience with document formatting for template compliance.
Key Competencies
Regulatory document review and quality assurance
Scientific editing and content validation
Compliance with global regulatory standards
Cross-functional collaboration
Attention to detail and analytical thinking
Time management and adaptability
About the Company
Thermo Fisher Scientific is a global leader in scientific research services, providing solutions that enable customers to make the world healthier, cleaner, and safer. Through its PPD clinical research portfolio, the company supports clinical trials, laboratory services, and drug development across more than 100 countries, helping bring innovative therapies to patients worldwide.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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