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Document Review Specialist II – Client Embedded
Thermo Fisher Scientific. Review highly technical scientific documents to ensure quality standards meet or exceed client expectations .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory medical writing, ensuring accuracy and clarity in scientific documents while adhering to industry standards and guidelines. Proficient in collaborating with internal clients and maintaining effective communication in a cross-cultural environment.
Highest-signal resume keywords
Regulatory Medical WritingKnowledge Of GCPKnowledge Of FDA RequirementsStrong Analytical AbilityAdvanced Computer Literacy
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Medical WritingEditingData VerificationDocument ReviewStatistical ConceptsScientific Language RevisionGrammatical AccuracyRegulatory Document ReviewKnowledge Of Medical TerminologyClient-Dedicated Role Experience
Soft Skills
Proficient Oral CommunicationProficient Written CommunicationCollaborative WorkIndependent WorkAdaptability
Tools & Technologies
Document Management SystemsTemplatesIndustry Standards
Industry Keywords
Pharmaceutical IndustryCRO IndustryICH GuidelinesClinical Study ReportsPatient Safety Narratives
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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