Clinical Label Manager

3+ years

Not Disclosed

Hyderabad

10 Jan. 15, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job ID: REQ-10030736
Location: Hyderabad, Telangana, India
Posted on: January 8, 2025
Employment Type: Full-time, Regular

Role Summary:

The Clinical Label Manager (CLM) ensures seamless execution of labeling activities for clinical trial supplies (IMP) to support an uninterrupted supply chain. This role emphasizes compliance with regulatory, study, and company standards, guaranteeing label quality and availability to avoid supply disruptions that could impact patients.

Key Responsibilities:

Labeling and Compliance:
- Generate and coordinate labels for IMP, medication/randomization lists, and schedules.
- Ensure compliance with study design, packaging materials, and country-specific Regulatory Authority (RA) standards.
- Maintain and update the Phrase Library for regulatory requirements and translations.
System and Process Management:
- Administer labeling systems and Randomization Reporting Tools (RRT).
- Support system enhancement initiatives.
- Perform GMP line unit checks and document outcomes as required.
Risk Management and Quality Assurance:
- Investigate and document quality events or deviations if certified.
- Notify leadership of non-compliance cases and propose solutions.
- Act as a subject matter expert during inspections and audits.
Stakeholder Coordination:
- Align and communicate with internal and external stakeholders, including service providers.
- Proactively mitigate risks and propose solutions to challenges.
Vendor and Financial Management:
- Coordinate vendor management activities and performance evaluations.
- Manage financial responsibilities, including grants, purchase orders, and invoice approvals.
Process Improvement and Mentorship:
- Contribute to process simplification and improvement initiatives.
- Mentor new CLM associates and ensure team adherence to processes.
General Duties:
- Ensure task completion within agreed timelines, quality standards, and quantity expectations.
- Align with Novartis values and behaviors.

Role Requirements:

Education and Experience:

At least 3 years in the chemical/pharmaceutical industry or 2 years in a specialized field.
Formal education or apprenticeship in logistics, technical, or business-related areas.

Skills and Competencies:

Basic knowledge of drug development and clinical supply processes.
Familiarity with HSE/GMP standards.
Proficient in project management, problem-solving, and presentation skills.
Strong communication, negotiation, and interpersonal abilities.
Ability to work effectively in interdisciplinary teams.

Leadership and Organizational Skills:

Fundamental leadership capabilities.
Strong organizational and planning proficiency.

Why Novartis?

At Novartis, we go beyond innovation by fostering a supportive, collaborative community dedicated to improving patients' lives. Join us in creating breakthroughs that transform healthcare and build a brighter future.

Benefits and Rewards:
Discover the comprehensive personal and professional benefits offered by Novartis in our Life Handbook.

Diversity and Inclusion:
We are committed to building an inclusive and diverse work environment.

Accessibility:
For accommodations related to disabilities or medical conditions, email diversityandincl.india@novartis.com with the job requisition number and your contact information.

Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Location: Hyderabad, Telangana, India

Ready to make a difference in clinical supply management? Apply Now

Slug: clinical-label-manager-hyderabad-2025

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Clinical Label Manager

Job Description

Clinical Label Manager

Role Summary:

Key Responsibilities:

Role Requirements:

Why Novartis?

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