Job Description – Document Review Specialist II (Medical Writing FSP Team)
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: Remote (APAC Region)
Department: Medical Writing – Functional Service Partnership (FSP)
Job Type: Full-time
Work Schedule: Other
Work Environment: Office / Remote
About Thermo Fisher Scientific
At Thermo Fisher Scientific, you will discover meaningful work that makes a global impact. Our mission is to enable our customers to make the world healthier, cleaner, and safer.
With clinical trials conducted in 100+ countries and novel frameworks for digital and decentralized clinical research, we provide teams with resources to achieve career goals while delivering life-changing therapies.
Role Summary
The Document Review Specialist II will be part of the growing Medical Writing FSP Team in APAC, dedicated to one or more clients. The role focuses on reviewing regulatory and clinical documents to ensure quality, consistency, compliance with guidelines, and client expectations.
This is a remote-based position requiring high attention to detail, strong English proficiency, and expertise in regulatory document review and editing.
Key Responsibilities
Review a wide range of highly technical scientific documents (e.g., submission documents, study protocols, amendments, clinical study reports, investigator’s brochures, safety narratives).
Ensure accuracy, clarity, consistency, and compliance with regulatory standards and guidelines.
Verify data in tables, listings, and figures against source documents.
Edit scientific content for accuracy, flow, grammar, and appropriateness for intended audiences.
Adjust schedules to accommodate priority review requests.
Proactively query authors to ensure scientific accuracy and alignment with client preferences.
Maintain and apply knowledge of current templates, style guides, client guidelines, and industry standards.
Qualifications
Education & Experience
Bachelor’s degree or equivalent academic/vocational qualification required.
2+ years’ relevant experience, preferably in pharmaceutical or CRO industry.
CRO experience in client-dedicated roles or handling multiple projects with 1–2 clients is preferred.
Equivalent combinations of education, training, and directly related experience may be considered.
Knowledge, Skills & Abilities
Strong ability to focus on document details and broader objectives.
Good knowledge of medical writing processes, medical terminology, statistical concepts, GCP, and ICH guidelines.
Understanding of FDA and international regulatory agency requirements.
Excellent oral and written communication skills with grammatical accuracy.
Strong analytical, organizational, and planning skills.
Proficiency in document management systems and advanced computer literacy.
Team-oriented with good interpersonal skills; ability to work in cross-cultural, geographically dispersed teams.
Ability to perform under pressure, remain motivated, and work independently.
What We Offer
Competitive salary with a comprehensive health and well-being benefits package.
Flexible working culture supporting work-life balance.
An award-winning learning and development program to support professional growth.
A collaborative environment where global expertise is shared with a local team spirit.
Opportunities to contribute to life-changing therapies with a mission-driven organization.
Our Values
At Thermo Fisher Scientific, we live by our values:
Integrity
Intensity
Innovation
Involvement
Join a team of 100,000+ colleagues worldwide, working together to accelerate research, solve complex challenges, and support patients in need.
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