Document Quality Reviewer
Kachiguda, Hyderabad
4 years
QMS Document ReviewMedical WritingEditing grammarData AccuracyScientific WritingRegulatory DocumentsPatient rapport buildingInformed ConsentDocumentation for clinical studiesInvestigator’s BrochureStyle GuidesTechnical ReviewRoot Cause AnalysisCorrective and Preventive Action (CAPA)MS-Office ProficiencyDocument Management SystemsStatistical AnalysisClinical ResearchMultitaskingProcess Improvement
Job Description:
About the job::
The Document Quality Reviewer (DQR) II is responsible for conducting detailed quality reviews of medical writing deliverables to ensure the delivery of accurate, error-free, and high-quality clinical documents. The role involves correcting grammar, style, syntax, formatting, and ensuring accuracy and consistency of clinical data and scientific content. The DQR II identifies flaws in logic, ensures adherence to style guides and templates, and independently supports complex clinical documentation.
Key Responsibilities
• Perform comprehensive quality control of clinical documents such as patient narratives, informed consent forms, protocols, clinical study reports, investigator brochures, regulatory responses, and other submissions.
• Review technical terminology, grammar, data accuracy, and document flow to ensure clarity and integrity.
• Ensure consistency across documents and make formatting changes based on guidelines.
• Record quality findings using departmental procedures, escalate significant issues, and work with authors and team members to resolve discrepancies.
• Analyze recurring errors, identify root causes, and assist in corrective and preventive action planning.
Training & Compliance
• Complete all mandatory corporate, departmental, and project-specific training.
• Stay updated on industry developments through approved workshops and conferences and share learnings with the team.
• Provide guidance to new or less experienced staff.
General Duties
• Participate in departmental and company meetings.
• Follow all departmental processes, including workload tracking.
• Contribute to process improvement initiatives and team knowledge-sharing activities.
Skills & Competencies
• High attention to detail, strong proofreading and copyediting abilities, and consistent delivery of quality output.
• Ability to interpret statistical data; understanding of clinical research concepts is an advantage.
• Ability to manage multiple tasks, prioritize effectively, and work flexibly in a matrix environment.
• Strong MS Office and document management system skills, with the ability to learn new tools quickly.
Qualifications & Experience
• Bachelor’s degree in Life Sciences or related fields.
• Minimum 4+ years of experience in the pharmaceutical or clinical research industry, preferably in medical writing, proofreading, and quality control.
• Good understanding of regulatory documents, ICH-GCP guidelines, and the drug development lifecycle.
