Senior Associate, Quality Control

📋 Description

• Defines scope of quality control activities with the document author and required source data.
• Conducts independent quality control reviews of documents against source data to ensure accuracy.
• Ensures QC documentation is complete, accurate, and uploaded to the master file per processes.
• Maintains knowledge of clinical regulatory documents needing QC review and related processes.
• Mentors staff and oversees contractors as delegated.
• Leads development and maintenance of QC-related medical writing operations processes and SME for

🎯 Requirements

• Bachelor’s degree required; sciences, English, or communication preferred.
• 3-4 years in QC/review of clinical regulatory documents or related areas (QA, clinical research
• Project management experience preferred.
• Strong knowledge of clinical documents, eCTD structure, CTD templates, and regulatory guidelines.
• Experience with cross-functional teams and prioritization under changing workload.
• Proficient in MS Office (Excel, Outlook, PowerPoint, Word) and document/file formats; familiarity

🎁 Benefits

• Competitive compensation and benefits package.
• Paid time off and health insurance options.
• Eligibility to participate in incentive programs.