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
• 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

Ref.Nr.:

• 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