Document Review Specialist II – Client Embedded (FSP)
Core
Review regulatory medical writing documents (submissions, protocols, CSRs, IBs, PSRs) to ensure quality, accuracy, and adherence to client guidelines and industry standards.
Role type
Senior IC medical writing document reviewer
Builds
Regulatory submissions and clinical study documentation for pharmaceutical clients
Domain
Clinical research / Medical writing / Regulatory affairs
Required skills
Medical writing, regulatory document review, data verification against source documents, scientific editing, medical terminology, GCP, ICH guidelines, FDA requirements, document management systems
Preferred skills
Pharmaceutical/CRO industry experience, client-dedicated role experience, statistical concepts
Technologies
Document management systems
Responsibilities
Review highly technical scientific documents for quality and client expectations; Verify scientific logic and data consistency; Edit for accuracy, consistency, and grammar; Query authors for scientific soundness; Maintain knowledge of current guidelines and templates
Seniority
Mid-level, hands-on IC
