Clinical Label Reviewer

📋 Description

• Independently designs, reviews, and approves study-specific clinical label content and templates
• Review study protocols and related documentation to determine global clinical label requirements
• Create, design, critically review, and approve study-specific and global clinical label templates
• Ensure label text, templates, and approvals comply with GMP/cGMP, applicable procedures, and global
• Obtain, document, and maintain required approvals from Regulatory Affairs, Quality Assurance
• Maintain the global clinical label phrase library: approve new controlled phrases, conduct annual

🎯 Requirements

• Bachelor's degree or equivalent combination of education and relevant experience.
• Demonstrated experience in clinical label design, clinical supply, pharmaceutical packaging, or
• Working knowledge of GMP/cGMP and global clinical-labeling requirements, including US, EU, JAPAC
• Ability to interpret clinical protocols, apply regulatory requirements, produce accurate
• Strong quality, analytical, organizational, project-management, communication, and issue-escalation
• Preferred: 3-5+ years of clinical trial design, clinical labeling, packaging, or pharmaceutical

🎁 Benefits

• Pay disclosure: compensation range of $58,656 to $103,500 per year based on job grade and
• Comprehensive benefits package including paid time off (vacation, holidays, sick)
• Eligible for short-term incentive programs.
• Equal Opportunity Employer/Veterans/Disabled.