Global Labeling Manager
Global Labeling Manager
Job Description200+ projects in development. 20 major approvals. 20 major submissions. And that’s just in 2018. This is your chance to help reimagine medicine in 2019. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide. And it all starts with you. Your interest, your talent, your initiative. Take the first step by looking at our track record of amazing accomplishments on behalf of our patients. Novartis employees have enjoyed long, rewarding careers working with colleagues around the world via flexible, family friendly arrangements. Read on for details about the role and how you can join a world-class organization at the forefront of the industry and how you can further your career.
The DRA Global Labeling Manager (GLM) is responsible for the maintenance of regulatory compliant, competitive, and up-to-date core labeling documents for assigned marketed products throughout the product lifecycle in accordance with Novartis policies and procedures. The DRA GLM provides strategic and operational regulatory labeling input and works in close collaboration with Expert Labeling Task Force (ELTF) members, DRA sub-teams, and CPOs to ensure that core labeling documents are aligned with the company’s position on the product’s profile and are in accordance with Novartis labeling processes and standards.
Responsibilities will include but are not limited to:
Regulatory Labeling Strategy:
• Represent DRA GL as a core member of Safety Management Teams (SMTs) and DRA sub-teams for their assigned marketed products
• Review and assess competitor labeling for marketed products within the same pharmacological class to support key projects and periodic core labeling updates
• Review and assess local country labels to identify deviations from the core labeling and propose topics for further cross-functional assessment during the periodic core labeling review process
Contribute to DRA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products
• Contribute to overall Global Labeling and liability risk management strategy for Novartis Pharma including review of inter-divisional or cross-company pharmacovigilance agreements. Regulatory Labeling Activities:
• Global Product Information: Maintain regulatory compliant, competitive and up to date core labeling documents (Core Data Sheet (CDS), Basic Patient Leaflet (BPL), Basic Succinct Statement (BSS), and International Package Leaflets (IPL)) for assigned marketed products. Ensure adequate reflection of key regional/CPO input (e.g. EU, US) when revising the CDS.
• CDS Supporting Documents: Contribute to the creation of high quality documents supporting changes to the CDS with internal and/or external experts including the preparation of responses to labeling-related Health Authority queries.
• Global Labeling Committee (GLC): Present and defend proposed changes to global core labeling documents, including labeling documents in key markets, to the GLC for review and approval. Ensure that key country label proposals which deviate from a proposed CDS or CDS amendment/update (e.g., US PI, EU SmPC) are brought to the attention of the GLC, together with rationale. etc.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirementsWhat you'll bring to this role:
• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred
• Minimum of 2 years experience in global labeling or other regulatory affairs functions, alternatively 5 years experience in related areas of the Pharmaceutical Industry or Health Authorities.
WHY CONSIDER NOVARTIS?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.