Quality Control Specialist

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