Analyst Clinical Label Management

Why This Role Matters
The Analyst Clinical Label Management role at Novartis is essential for ensuring accuracy, compliance, and traceability in clinical trial labeling processes. Proper labeling of Investigational Medicinal Products (IMP) is critical for patient safety, regulatory compliance, and trial integrity. This role supports global clinical operations by ensuring that labeling activities are executed with precision and aligned with regulatory and study-specific requirements.

Job Description
The Analyst Clinical Label Management is responsible for executing labeling activities for clinical trials, including label design, documentation, and compliance monitoring. This role involves close collaboration with internal teams and external stakeholders to ensure that all labeling processes are completed accurately, on time, and in line with global regulatory standards and study protocols.

Key Features of the Role:
• Role based in India with involvement in global clinical trials
• Focus on clinical trial labeling and IMP management
• Strong alignment with regulatory compliance and GMP standards
• Interaction with supply chain, clinical, and external vendors
• Opportunity to work on global labeling strategies and processes
• Exposure to documentation systems and compliance audits
• Structured and process-driven work environment

Responsibilities
• Generate and design labels for Investigational Medicinal Products (IMP)
• Prepare randomization lists and schedules as per study requirements
• Ensure labeling aligns with study design, pack design, and regulatory standards
• Manage and track assigned tasks and tickets for workflow continuity
• Upload and maintain study-related documents and templates in systems
• Provide regular updates and status reports to the Label Lead
• Maintain and update Phrase Library for country-specific requirements
• Ensure compliance with Health Authority (HA) regulations and company standards
• Perform GMP line unit checks (if certified) and document results
• Identify and report deviations or quality issues
• Collaborate with internal teams (clinical supply, supply chain) and external vendors
• Support audit and inspection readiness
• Participate in projects, networks, and continuous improvement initiatives

Required Qualifications
• Strong understanding of clinical trial processes and labeling requirements
• Knowledge of GMP, HSE, and regulatory compliance standards
• Good project management and organizational skills
• Strong communication and stakeholder management abilities
• Ability to work in cross-functional and interdisciplinary teams

Educational Requirements:
• Degree in Science, Engineering, or equivalent field

Experience and Skills:
• Minimum 2+ years of experience in pharmaceutical or chemical industry
• OR 3+ years of relevant experience in labeling or related field
• Experience in clinical trial supply or labeling processes preferred
• Basic project management and planning skills
• Strong problem-solving and analytical abilities
• Good documentation and reporting skills
• Familiarity with regulatory and compliance requirements
• Strong interpersonal and communication skills

Salary Insights
• Competitive salary based on experience and industry standards
• Additional benefits including performance incentives and career development opportunities

Company Overview
Novartis is a leading global healthcare company focused on reimagining medicine to improve and extend people’s lives. With a strong presence in clinical research, innovation, and regulatory excellence, Novartis continues to deliver high-quality healthcare solutions across the world.

FAQs
• What is the main focus of this role?
Clinical trial labeling and compliance for investigational products.

• Is prior labeling experience required?
Preferred, but relevant pharma or clinical experience is acceptable.

• Does the role involve regulatory compliance?
Yes, it involves adherence to GMP and Health Authority requirements.

• Will I work with global teams?
Yes, the role involves collaboration with global stakeholders.

• What qualifications are required?
A degree in science, engineering, or related field.

Application Tips
• Highlight experience in clinical trials, labeling, or supply chain
• Showcase knowledge of GMP, HSE, and regulatory standards
• Emphasize attention to detail and documentation skills
• Include examples of cross-functional collaboration
• Demonstrate project management and organizational abilities
• Tailor your CV to reflect compliance and quality-focused experience