Quality Control Specialist

Job Summary

A company is looking for a Medical Writing QC Specialist to support the review and verification of clinical regulatory documents.

Key Responsibilities

• Define the scope of quality control activities and identify required source documents and data
• Conduct independent QC reviews of regulatory documents, verifying data accuracy against source materials
• Collaborate with medical writers and managers to review deliverables and ensure timely completion of QC activities

Required Qualifications

• Bachelor's degree in Science, English, Communications, or related field
• 2-3 years of experience in quality control/review of clinical regulatory documents or related areas
• Strong understanding of clinical documents, eCTD structure, and CTD templates
• Familiarity with regulatory submission standards and drug development processes
• Ability to manage multiple projects and work independently with limited oversight