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Clinical Label Manager

3+ years
Not Disclosed
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Label Manager

Location: India
Job ID: REQ-10030736
Department: Clinical Trial Supply

About the Role

The Clinical Label Manager (CLM) is responsible for managing and coordinating labelling activities for clinical trial supplies (IMP). The role ensures timely and accurate label generation, adhering to regulatory and quality standards while meeting key milestones in the supply chain. The CLM works closely with internal and external stakeholders to avoid supply interruptions and ensure compliance.

Key Responsibilities

  • Label Generation & Compliance:

    • Coordinate and generate labels for IMP and related documents, ensuring compliance with study design, pack material, regulatory authority requirements, and Novartis standards.
    • Maintain a Phrase Library for country-specific translations and regulatory requirements.
  • System & Vendor Management:

    • Manage business administration of labelling systems and participate in system enhancements.
    • Lead investigations for any deviations in label quality or non-Right First Time (RFT) cases.
    • Oversee vendor management, ensuring performance and compliance with quality standards.
  • Collaboration & Communication:

    • Act as a subject matter expert on the label process during internal and external inspections.
    • Communicate challenges and propose solutions to internal and external stakeholders.
    • Support process improvement initiatives within the labelling function.
  • Quality & Process Adherence:

    • Ensure adherence to GMP standards and Novartis values, ensuring timely and accurate execution of tasks.
    • Provide mentorship to new CLM associates and support colleagues in following appropriate processes.
  • Project Participation:

    • Actively engage in projects and forums, contributing to process simplification and improvements.

Role Requirements

  • Experience:

    • 3 years of practical experience in the chemical/pharmaceutical industry, or >2 years in clinical supply or related fields.
    • Basic knowledge of drug development, clinical supply processes, and project management.
  • Skills:

    • Knowledge of HSE/GMP standards, problem-solving, and organizational skills.
    • Strong communication, negotiation, and interpersonal skills, with the ability to work in interdisciplinary teams.
  • Education:

    • Apprenticeship or formal education in logistics, technical, or related business areas.

Why Novartis?

At Novartis, we strive to create a collaborative environment where passionate individuals work together to achieve breakthroughs that change patients' lives. Join our team to help make a difference.

Benefits and Rewards

Explore the comprehensive benefits offered by Novartis to support your personal and professional growth. Learn more at Novartis Benefits and Rewards.

Join Our Network

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