Senior Global Labeling Manager vacancy for our Basel based client in the Pharma sector.

Your tasks:

• 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.

Your experience/knowledge:

• Extensive experience (at least 4-6 years) in global labeling or related areas of the pharmaceutical industry.
• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.
• Strong interpersonal, project management, communication, negotiation and problem-solving skills.
• Fluency in English as business language, additional languages advantageous

Location: Basel, Switzerland
Work setting: Hybrid
Sector: Pharma
Start: ASAP
Duration: 6+ months
Workload: 100%
Ref.Nr.: BH 23858

Take the next step and send us your resume along with a daytime phone number where we can reach you.

Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens, and current work-permit holders for Switzerland.

We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.

As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.