Analyst Clinical Label Management

Roles & Responsibilities:
• Design and generate IMP labels as per study and pack design requirements
• Execute label design based on Label Lead strategy and study inputs
• Manage randomization lists and schedules ensuring accuracy and timelines
• Ensure label compliance with study design, analytical specifications, GMP, and country-specific Health Authority requirements
• Maintain and update Phrase Library with HA-approved translations and phrases
• Upload and manage Study Label Templates (SLTs) and related study documents in repositories
• Perform GMP Line Unit Checks (LU1b) as per SOPs (if certified)
• Report deviations, quality events, and Right First Time (RFT) issues
• Coordinate with Clinical Trial Supply, Supply Chain teams, and external label vendors
• Support internal and external audits/inspections by explaining labeling processes
• Provide regular status updates and documentation to the Label Lead

Qualification:
• Degree in Science, Pharmacy, Engineering, or Life Sciences
• BSc / MSc (Life Sciences, Chemistry, Biotechnology)
• BPharm / MPharm or equivalent scientific/technical degree

Experience:
• Minimum 2 years in pharmaceutical or chemical industry
OR
• 3+ years in clinical labeling or clinical trial supply chain domain

Skills:
• Strong knowledge of GMP, HSE, and clinical trial labeling processes
• Experience with SAP ERP, Master Data, and Supply Chain systems
• Basic project management and planning skills
• Good communication, stakeholder management, and documentation skills
• Ability to work effectively in cross-functional and global teams

About the Organization:
Novartis is a global healthcare leader focused on reimagining medicine to improve and extend people’s lives, with a strong presence in innovative clinical development and global supply operations.