Job Title: Document Review Specialist II – Medical Writing
Location: Remote – India
Job ID: R-01325713
Employment Type: Full-Time
Category: Clinical Research
Work Mode: Fully Remote
Work Schedule: Other (flexible)
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader dedicated to enabling customers to make the world healthier, cleaner, and safer. Our Clinical Research team, supporting the PPD® clinical research portfolio, combines scientific expertise to accelerate drug development across 100+ countries, offering laboratory, digital, and decentralized clinical trial services.
Role Overview
As a Document Review Specialist II, you will be a key member of the Medical Writing Functional Service Partnership (FSP) team in APAC. You will review regulatory documents such as submission documents, protocols, amendments, clinical study reports, investigator brochures, and patient safety narratives. Your role ensures quality, adherence to client guidelines, editorial style guides, and regulatory standards.
Key Responsibilities
Review a variety of highly technical scientific documents to ensure quality and compliance with client and regulatory standards.
Verify scientific logic and clarity by cross-checking data in tables, listings, and figures against source documents.
Edit documents for accuracy, consistency, grammar, and clarity.
Manage schedules to accommodate priority or unexpected review requests.
Revise scientific language to improve flow, readability, and audience appropriateness.
Proactively query authors to align with client preferences and maintain scientific integrity.
Stay updated and apply knowledge of current guidelines, templates, and industry standards.
Collaborate effectively with internal clients and teams to ensure operational excellence.
Qualifications
Education
Bachelor’s degree or equivalent formal academic/vocational qualification.
Experience
Minimum of 2+ years of relevant experience, preferably in the pharmaceutical or CRO industry.
Experience in client-dedicated roles or managing multiple projects for 1-2 clients is preferred.
Equivalency through a combination of education, training, and experience may be considered.
Skills & Abilities
Strong attention to detail, with the ability to focus on both document specifics and overall messaging objectives.
Good understanding of medical writing methods, techniques, and procedures.
Strong analytical skills with good knowledge of medical terminology, statistical concepts, GCP, ICH guidelines, and FDA/international regulatory requirements.
Proficient oral and written communication skills with strong grammar and editorial capabilities.
Excellent organizational and planning skills.
Strong interpersonal skills and ability to work well in a team environment.
Advanced computer literacy and expertise with document management systems.
Ability to work under pressure and maintain motivation.
Capable of working independently and collaboratively within a geographically dispersed, cross-cultural team.
What We Offer
Award-winning learning and development programs to support your professional and personal growth.
Competitive salary and comprehensive benefits package focused on employee health and well-being.
Flexible working culture supporting work-life balance.
Collaborative global environment with a local feel.
Opportunity to work alongside 100,000+ colleagues united by core values: Integrity, Intensity, Innovation, and Involvement.
Work Environment & Accessibility
Remote work environment with emphasis on effective communication across diverse teams.
Reasonable accommodations provided for individuals with disabilities throughout the hiring and employment process. Please contact us to request accommodations.
Equal Opportunity Statement
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age, or disability.
Learn More & Apply
Visit: www.thermofisher.com
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