Analyst - Clinical Label Management

Role & Responsibilities
• Design and generate IMP labels as per study and pack design requirements
• Execute label designs based on Label Lead strategy and approved 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 standard phrases
• Upload and manage Study Label Templates (SLTs) and study documents in repositories
• Perform GMP Line Unit Checks (LU1b) when certified, in line with SOPs
• Report deviations, quality events, and Right-First-Time (RFT) issues
• Coordinate with Clinical Trial Supply, Supply Chain, and external label vendors
• Support internal and external inspections by explaining labeling processes
• Provide regular status updates, documentation, and metrics to the Label Lead

Qualification
• BSc / MSc (Life Sciences, Chemistry, Biotechnology)
• B.Pharm / M.Pharm / Pharm.D
• Equivalent scientific or technical degree

Experience
• 2+ years in pharmaceutical or chemical industry
• OR 3+ years in clinical labeling or clinical supply chain roles

Skills
• Strong knowledge of GMP, HSE, and clinical trial labeling processes
• Experience with SAP ERP, master data, and supply chain systems
• Understanding of clinical trial supply and Health Authority compliance
• Basic project planning and coordination skills
• Strong communication, stakeholder management, and documentation skills
• Ability to work effectively in cross-functional, global teams

About the Company
• Novartis is a leading global healthcare company focused on reimagining medicine through science and data, Operates across research, development, manufacturing, and global clinical operations.