Global Labeling Associate - Bern, Schweiz - Swisslinx
Beschreibung
On behalf of our client, a leading biopharmaceutical company, we are looking for a Global Labeling Associate to join their team with a start date as soon as possible.
The position is initially 8 months with a 60% workload and the possibility to work remote.In this role you have the opportunity to lead and support implementation of on-going global projects with labeling impact to the foundational markets and rest of world.
Your mission:
- Collaborate with crucial stakeholders for the maintenance and execution of approved labeling variations into the electronic or printed package materials
- Support the GLO and provide foundational markets labels to GRA Region and ROW for NDAs, renewals, CPPs and request of labeling verification statements
- Be in charge of and implement labeling assessment in RIMS, and Trackwise system for global labeling changes
- Manage GCCrelated activities
- First time quality and compliance is to be ensured in all aspects of labeling as well as on time delivery of detailed packages
- Managing distribution of English manuscripts for multimarket labels based on EU/CP/MRP/DCP
- Working together with EU-GRA Lead in coordination of labeling activities for EU CP/MRP/DCP submissions (i.e., linguistic review, national translations)
Your background:
- At least 3 years of experience as a Labeling Associate or in a similar field
- Fluency in English is a must
- Able to start working as soon as possible
The possibility to implement ideas and make a difference in an international prominent company.
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