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Senior Global Labeling Manager

vor 1 Monat

Basel, Basel-Stadt, Schweiz WillHire Vollzeit

This is a temporary contractor opportunity at Novartis

Novartis touches the lives of a tenth of the world's population. Every role here, regardless of contract type, makes an impact on human life

Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit.

Ready to work with/through Magnit at Novartis? Please read on…

The RA Senior Global Labeling Manager (Sr. GLM) is responsible for the creation and maintenance of regulatory compliant, competitive, and up-to-date core labeling documents for assigned developmental programs and Novartis Innovative Medicines products.

The assigned products should be of higher complexity products and may include developmental programs.

The RA Sr. GLM provides strategic and operational regulatory labeling input and works in close collaboration with Expert Labeling Task Force (ELTF) members in creating or maintaining core labeling documents and handling HA or CO labeling queries for assigned products.

Major Accountabilities:

  1. Serve as the labeling lead for all labeling related topics.
  2. Maintain regulatory compliant, competitive and up to date global labeling documents (Core data sheet (CDS), Basic Patient leaflet (BPL), Basic Succinct Statement (BSS) for assigned products.
  3. Present to GLC on CDS changes.
  4. Organize and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate.
  5. Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products.
  6. Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
  7. Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries.
  8. Interact with COs to ensure timely implementation of global labeling changes in local product information, and ensure international consistency and compliance with the CDS.
  9. Contribute to RA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products.
  10. Contribute to/lead presentations on labeling related topics for the assigned products at relevant board/forum/committee (e.g., MSRB, PSB).
  11. Prepare and/or review PSUR RA input for assigned products.
  12. Review and release International Package Leaflets for assigned products.
  13. Mentor newcomers and less experienced GLMs.
  14. Contribute to global labeling management and continuous improvement initiatives.
  15. Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
  16. Represent GL during audits and inspections.

Requirements:

  1. Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.
  2. Fluency in English as business language, additional languages advantageous.
  3. Extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience (5 + years) in related areas of the pharmaceutical industry or Health Authorities.
  4. Strong interpersonal, project management, communication, negotiation and problem solving skills.
  5. Ability to lead cross-functional teams in a matrix environment.
  6. Organizational awareness (interrelationship of departments, business priorities).
  7. Sound understanding of medical and scientific terminologies.
  8. Good understanding of drug safety information.

Workload: 100% (40 hours per week)

Role type: Onsite or remote within Switzerland with occasional travel.

Estimated Start date: April 2025

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here.

Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here.

Accommodation: If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.

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