Analyst, Clinical Label Management

Novartis

1-3 years

Not Disclosed

Hyderabad

1 May 6, 2026

Job Description

Job Type: Full Time Education: Bachelor’s Degree or Master’s Degree in: Pharmacy Life Sciences Biotechnology Clinical Research Pharmaceutical Sciences Healthcare Management Supply Chain Management Or related disciplines Skills: gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management

Analyst – Clinical Label Management

Location: Hyderabad (Office)
Job Type: Full-Time
Experience Required: 1–3 Years in Pharmaceutical or Clinical Operations Domain
Application Deadline: May 7, 2026
Industry: Pharmaceutical / Clinical Research / Healthcare

Job Overview

We are seeking a detail-oriented and quality-focused Analyst – Clinical Label Management to support clinical trial labeling operations and ensure accurate execution of labeling activities for investigational medicinal products (IMP). The ideal candidate will be responsible for label generation, documentation management, compliance tracking, and coordination with internal and external stakeholders to support smooth clinical trial supply operations.

This role is ideal for professionals with experience in pharmaceutical operations, clinical supply chain management, GMP environments, and GxP-compliant documentation processes.

Key Responsibilities

Clinical Label Management

Generate and manage labels for:
- Investigational Medicinal Products (IMP)
- Randomization lists
- Randomization schedules
Design study labels based on approved label strategies and clinical study requirements.
Ensure labeling milestones, timelines, and quality standards are achieved effectively.
Upload Study Label Templates (SLTs), study forms, and related documentation into designated repositories accurately.

Compliance & Quality Assurance

Ensure label compliance with:
- Clinical study design
- Packaging specifications
- Country-specific Health Authority (HA) requirements
- Internal quality standards
Maintain and update the Phrase Library containing:
- Country-specific regulatory phrases
- Approved translations
- Validated compliance statements
Perform GMP line unit checks (LU1b) when certified and required under SOP guidelines.
Report quality deviations, non-compliance cases, and operational issues to leadership teams promptly.

Stakeholder Coordination

Collaborate with:
- Clinical Trial Supply Managers
- Supply Chain Teams
- External labeling vendors
- Cross-functional operational teams
Provide regular task updates and progress reports to the Label Lead.
Support inspection readiness and respond to internal or external audit-related questions regarding labeling processes.

Operational Excellence

Ensure all assigned activities are completed within quality, quantity, and timeline expectations.
Follow standard operating procedures (SOPs), compliance protocols, and organizational processes consistently.
Participate in process improvement initiatives, projects, operational forums, and knowledge-sharing activities.
Maintain alignment with organizational values, safety standards, and compliance frameworks.

Required Qualifications

Educational Qualifications

Preferred Education Level:

Bachelor’s Degree or Master’s Degree in:
- Pharmacy
- Life Sciences
- Biotechnology
- Clinical Research
- Pharmaceutical Sciences
- Healthcare Management
- Supply Chain Management
- Or related disciplines

Preferred Certifications:

GMP / GxP Certification
Clinical Research Certification
SAP ERP or Supply Chain Management Certification (preferred but not mandatory)

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