Senior Global Labeling Manager (m/f/d), 100%

• An internationally operating, innovative Swiss pharmaceutical company, a leader in its field
• Flexible working hours and extensive training opportunities
• A motivated multicultural team and environment

• 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.

• 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

Fragen?