Quality Control Specialist

Job Summary

To support a growing Global Medical Writing team, the full-time Quality Control Specialist will coordinate and complete QC reviews of clinical and regulatory documents, ensuring compliance with standards while working remotely.

Key responsibilities

• Perform quality checks, copyediting, and proofreading of clinical and regulatory documents to ensure accuracy and compliance
• Manage multiple projects simultaneously, adhering to tight timelines and communicating effectively with Medical Writers
• Build partnerships with intradepartmental teams and engage in training to enhance knowledge of medical writing and regulatory requirements

Required qualifications

• BA/BS degree; advanced degrees such as a Masters, PhD/PharmD are a plus
• At least 1 year of relevant experience in QC editing, medical writing, or technical copyediting
• Experience with pharmaceutical industry regulatory documents, including clinical study reports and protocols
• Familiarity with drug/biologics development processes and regulatory submission requirements
• Technical expertise in Microsoft Office Suite and Adobe Acrobat; familiarity with SharePoint and Veeva Vault is a plus