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Novartis is hiring an Analyst – Clinical Label Management for its Hyderabad office. This full-time role supports clinical trial labeling activities, ensuring IMP label design, compliance with GMP and Health Authority requirements, and timely delivery aligned with global clinical supply strategies.
This opportunity is ideal for BSc, MSc, BPharm, MPharm, or Life Sciences graduates with hands-on experience in clinical trial supply, labeling operations, or pharmaceutical manufacturing.
🔬 Key Responsibilities – Clinical Label Management Analyst
- Design and generate IMP labels as per study and pack design requirements
- Manage randomization lists and schedules ensuring accuracy and timelines
- Execute label design based on Label Lead strategy and study inputs
- Ensure label compliance with study design, analytical specs, GMP, and country-specific HA requirements
- Maintain and update Phrase Library (HA-approved translations and phrases)
- Upload and manage Study Label Templates (SLTs) and study documents in repositories
- Perform GMP Line Unit Checks (LU1b) if certified, as per SOPs
- Report deviations, quality events, and RFT (Right First Time) 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 and documentation to the Label Lead
🎓 Education & Qualifications
Minimum Qualification:
- Degree in Science, Pharmacy, Engineering, or Life Sciences
Eligible Degrees Include:
- BSc / MSc (Life Sciences, Chemistry, Biotechnology)
- BPharm / MPharm
- Equivalent scientific or technical degrees
🧪 Required Work Experience & Skills
- 2+ years in pharmaceutical or chemical industry
- OR 3+ years in clinical labeling / supply chain domain
- 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 in cross-functional and global teams
🧠 Desired Skills (Keywords)
Clinical Label Management, IMP Labeling, GMP Compliance, SAP ERP, Clinical Trial Supply, Supply Chain Management, Warehouse Management, Logistics, Operational Excellence, Health Authority Compliance
💼 Benefits of Working at Novartis
- Competitive salary and performance benefits
- Exposure to global clinical trials and regulatory standards
- Strong focus on quality, compliance, and innovation
- Hybrid working model with collaborative teams
- Career growth in clinical operations and supply chain domains
📍 Job Location & Details
- Location: Hyderabad (Office-based)
- Job Type: Full-time
- Working Model: Hybrid
📝 How to Apply
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