Job Description

#CoreLabelingDocuments #RegulatoryComplaint #DevelopmentalPrograms #InnovativeMedicincesProducts #TopJob #YourNewJob

Our customer, a pharmaceutical company based in the area of Basel, needs reinforcement. For a temporary employment (duration: asap – 08.2025) we are looking for a

   

Benefits

  • 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

Your responsibilities

  • 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.

Requirements

  • 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?

Für Fragen steht dir Renato Imboden gerne telefonisch unter +41 61 269 90 65 zur Verfügung.
 
 
Renato Imboden
Recruitment Business Partner

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