Join to apply for the Senior Global Labeling Manager role at Novartis
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 Magnit Global to offer engaging temporary contractor opportunities to those seeking flexibility while gaining new skills and experience providing services to an inclusive global medicines company. Read on to learn more about the role.
Major Accountabilities
* Serve as the labeling lead for all labeling related topics.
* 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.
* Present to GLC on CDS changes.
* Organize and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate.
* Represent GL as a core member of RA Sub-teams and Safety Management Teams SMTs for assigned projects/products.
* Research and understand labeling topics including reviewing labels across markets, competitor labels, study information, and labeling regulations.
* Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries.
* Interact with COs to ensure timely implementation of global labeling changes in local product information and ensure international consistency and compliance with the CDS.
* Contribute to RA activities regarding safety risk communications and portfolio stewardship with labeling impact for assigned projects/products.
* Contribute to/lead presentations on labeling topics for assigned products at relevant boards/fora (e.g., MSRB, PSB).
* Prepare and/or review PSUR RA input for assigned products.
* Review and release International Package Leaflets for assigned products.
* Mentor newcomers and less experienced GLMs.
* Contribute to global labeling management and continuous improvement initiatives.
* Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
* Represent GL during audits and inspections.
Key Performance Indicators (KPIs)
* Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes.
* Fulfill labeling responsibilities to achieve business objectives for assigned products and brands.
* Timely management of core labeling documents for the assigned products and brands; ensure labeling strategy is presented to relevant boards.
* Collaborate with ELTF to minimize NPI deviations and document rationale for deviations appropriately.
Requirements for the position
* Science-based BS or MS with requisite experience; advanced degree (MD, PhD, PharmD) preferred.
* Fluency in English as business language; additional languages advantageous.
* Extensive experience (at least 4–6 years) in global labeling, or extensive experience (5+ years) in related pharmaceutical industry or Health Authorities.
* Strong interpersonal, project management, communication, negotiation and problem-solving skills.
* Ability to lead cross-functional teams in a matrix environment.
* Organizational awareness and understanding of interdepartmental relationships and business priorities.
* Solid understanding of medical and scientific terminologies.
* Good understanding of drug safety information.
Workload: 100% (40 hours per week)
Role type: Hybrid (3 days/week onsite)
Required start date: October 2025
Contract end date: June 2026
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 to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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.
Referrals increase your chances of interviewing at Novartis by 2x
Get notified about new Senior Manager jobs in Basel, Basel, Switzerland.
#J-18808-Ljbffr