Document Review Specialist II – Client Embedded

🔥 11 minutes ago

🌐 United Kingdom, Serbia – Remote

🇬🇧 United Kingdom – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Review highly technical scientific documents to ensure quality standards meet or exceed client expectations • Verify scientific logic and clarity by checking data in tables, listings, and figures against source documents • Check consistency according to current regulatory standards and guidelines • Edit documents for accuracy, consistency, and grammatical correctness • Adjust schedules to accommodate unexpected priority review requests • Revise scientific language for usage, flow, clarity, and audience appropriateness • Query authors proactively regarding unique preferences and scientifically sound judgment • Maintain, communicate, and apply knowledge of current guidelines, templates, and industry standards • Collaborate with internal clients to support effective communication and operational excellence • Review regulatory documents including submission documents, protocols and amendments, clinical study reports, investigator’s brochures, and patient safety narratives

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification required • At least 2 years' experience in regulatory Medical Writing • Previous editorial experience comparable to 2+ years • Experience working in the pharmaceutical/CRO industry preferred • If CRO experience, experience working in a client-dedicated role or with 1 to 2 clients over multiple projects preferred • Equivalency may consist of a combination of appropriate education, training, and/or directly related editorial experience • Knowledge of methods, techniques, and procedures of medical writing tasks • Strong analytical ability • Working knowledge of medical terminology and statistical concepts • Knowledge of GCP and guidelines such as ICH • Knowledge of FDA and other international regulatory agency requirements • Proficient oral and written communication and grammatical skills • Advanced computer literacy and expertise • Knowledge and understanding of document management systems • Ability to work independently and collaboratively in a cross-cultural, geographically dispersed environment • High English proficiency

🏖️ Benefits

• Award-winning learning and development programme • Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Collaborative environment • Opportunities to share expertise and grow professionally and personally

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