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Team Head Clinical Label Management

Novartis
12+ years
Not Disclosed
Hyderabad
10 May 20, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company: Novartis
Novartis Official Website
Location: Hyderabad (Office)
Employment Type: Full-time
Requisition ID: REQ-10065078
Application Deadline: May 31, 2026


1. Role Overview

The Team Head – Clinical Label Management leads a team responsible for end-to-end clinical labeling operations within Global Clinical Supply (GCS).

The role carries full functional ownership of Clinical Label Management (CLM) deliverables, ensuring compliance, operational excellence, and timely execution across clinical trial labeling activities.

It is both a people leadership and operational execution role, requiring strong stakeholder coordination across global supply, regulatory, and clinical functions.


2. Core Responsibilities

A. Team Leadership & People Management

  • Lead and manage a team of Clinical Label Managers

  • Own performance management, talent development, and hiring decisions

  • Drive objective setting and development planning

  • Build a high-performance, diverse, and inclusive team culture

  • Provide first-line escalation for operational challenges


B. Operational Delivery & Execution

  • Ensure delivery of Clinical Label Management outputs across projects

  • Assign CLMs to projects based on complexity and expertise

  • Ensure adherence to:

    • Timelines

    • Budget constraints

    • Quality standards

    • Compliance requirements

  • Align team execution with Global Clinical Supply planning cycles


C. Compliance & Quality Oversight

  • Ensure compliance with:

    • GMP (Good Manufacturing Practices)

    • HSE (Health, Safety & Environment)

    • Data integrity and data privacy standards

    • Internal Novartis quality systems

  • Support audits and inspections (internal & external)

  • Ensure all labeling deliverables meet regulatory and legal requirements


D. Stakeholder Management & Cross-Functional Collaboration

  • Manage interfaces with global stakeholders across Clinical Supply and other functions

  • Ensure alignment with regulatory, manufacturing, and supply chain teams

  • Build strong, credible relationships across functions and geographies


E. Process Excellence & Continuous Improvement

  • Drive continuous improvement in labeling processes

  • Promote best practices and knowledge sharing

  • Foster innovation, efficiency, and standardization

  • Adapt priorities based on evolving business needs


F. Strategic & Operational Planning

  • Manage resource planning for CLM portfolio

  • Support project prioritization and allocation

  • Contribute to operational planning and execution strategies

  • Ensure alignment with global supply chain requirements


3. Required Qualifications

Experience

  • 12+ years in pharmaceutical or chemical industry

  • 8–10 years of direct people management experience

  • Experience working in global, cross-functional environments

  • Strong exposure to clinical or commercial labeling and regulatory environments


Domain Knowledge

  • Drug development lifecycle understanding

  • Clinical and/or commercial labeling processes

  • Regulatory and GMP requirements

  • Supply chain and clinical supply planning


4. Core Skills

Leadership & People Skills

  • People management and team development

  • Performance management

  • Conflict resolution and escalation handling

  • Leadership in global matrix environments


Operational Skills

  • Clinical labeling operations

  • Resource and project planning

  • Supply chain and production planning

  • Materials and master data management


Compliance & Regulatory Skills

  • GMP compliance

  • HSE standards

  • Data integrity and privacy compliance

  • Audit readiness and inspection support


Soft Skills

  • Strong communication and negotiation

  • Stakeholder management

  • Problem-solving and decision-making

  • Organizational and planning ability


5. Key Skill Areas (From JD Keywords)

  • Clinical Label Management & Regulatory Compliance

  • Supply Chain & Production Planning

  • People Leadership & Team Management

  • Continuous Improvement (CI)

  • Materials / Master Data / Warehouse Systems (WMS)

  • Cross-functional stakeholder coordination


6. Organizational Context

This role sits within Global Clinical Supply (GCS), supporting clinical trial labeling operations across global markets. It ensures that clinical trial materials are accurately labeled, compliant, and delivered on time to support drug development and clinical studies.