Job Description

Position: Quality Review Specialist/Senior Specialist, Clinical Protocols Location: Hyderabad Position Summary Ensure scientific quality of clinical protocols and regulatory documents through data verification, inter-document consistency and message clarity reviews. Strong exposure into Clinical Protocols is required. Candidates would be responsible for Quality Check/Control/Assurance activities, and preparing QC checklists. Exposure into Clinical Summary, Clinical Efficacy, Clinical Protocol is required. Key Responsibilities Critically reviews complex clinical documents (protocols, CTD summary document) for timely submission to health authorities worldwide ensuring: accuracy between in text tabular or graphical presentations and referenced source materials. consistency between text data and messaging to tabular presentations or graphical displays. inter-document consistency between data and messaging between submission level documents and referenced source documentation. accuracy in document cross-referencing including hyperlinks to sections, endnotes and data outputs. Adherence to acronym and abbreviation convention, reference format, and section/table sequencing. Participate in continuous improvement workstream to enhance quality and increase efficiency of document reviews. Qualifications & Experience Minimum of BS/BA degree with 1 to 4 years of regulatory documentation experience in complex quality review of clinical protocols, study reports and submission documents . Understanding of clinical protocol documentation is preferred. Demonstrated ability to interpret complex data from a broad range of scientific disciplines to enable critical scientific reviews for protocol and submission level documents. Familiarity with clinical protocol content and document organization. Thorough understanding of regulatory document review standards and QC processes. Thorough understanding of style guides and checklists usage for quality review. Specialized knowledge of proofreading techniques for clinical and submission documents. Excellent attention to detail in reviewing documents for data accuracy, consistency and pull-through. Working knowledge of an electronic document management system and PDF annotation tools to facilitate document reviews.

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