Novartis
Website:
novartis.com
Job details:
Summary
- Provides the labeling/artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides The Global Labelling Content Manager plays a supporting role in ensuring accurate, consistent, and compliant global labelling content. They contribute to the reliability and traceability of core product information, helping enable high quality labelling-quality labelling across products and markets.
About The Role
Key Responsibilities:
- Serve as labelling lead for assigned products, developing and maintaining compliant global labelling documents (e.g., CDS, BPL, BSS, IFU) and major market labels (USPI/PPI/MG, EU SmPC/PIL and other priority countries).
- Organize and lead ELTF meetings to align content and comments, as appropriate for level.
- Collaborate with Global Labelling Directors / Associate Directors to ensure aligned, compliant, and competitive labelling content across assigned tasks. Flex on projects from Director or AD GL.
- Conduct detailed research across competitor labels, global regulations and study information to support content development.
- Prepare documentation supporting CDS changes and contribute to responses to Health Authority queries.
- Ensure timely country implementation of labelling changes and compliance with CDS requirements.
- Mentor newcomers and support readiness for audits, inspections and continuous improvement initiatives.
- Maintain appropriate document quality and traceability (version control, references and rationale) to support governance requirements and audit readiness.
- Development and maintenance of IPLs.
Minimum Requirements
- Typically, 2 to 5 years’ experience in Global Labelling, Regulatory Affairs, or related pharmaceutical development functions with demonstrated labelling drafting and maintenance experience.
- Working knowledge of core labelling concepts and major market formats (for example CDS, USPI, EU SmPC and PIL) and ability to apply internal standards and regulatory requirements.
- Ability to review and interpret clinical and safety information and translate into clear, consistent labelling text with appropriate referencing.
- Strong attention to detail and documentation discipline (version control, traceability, and rationale).
- Experience organizing and facilitating cross-functional meetings (for example ELTF) and managing actions to closure.
- Strong collaboration, communication, and prioritization skills; proactive issue identification and escalation.Continuous improvement mindset; experience supporting audits and inspection readiness activity
- Science-based BS or MS with demonstrated capability; advanced degree preferred
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Click on Apply to know more.