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…

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 the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
• 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/portfolio stewardship activities having labeling impact for their assigned projects/products.
• Contribute to/lead presentations on labeling related topics for the assigned products at relevant board/forum/committee (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 (escalating as appropriate) and document rationale for deviations appropriately

Requirements for the position:

• Science based BS or MS with requisite experience and demonstrated capability. 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, alternatively extensive experience (5 + years) in related areas of the 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 (interrelationship of departments, business priorities)
• Sound 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. Combining 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.