Global Labeling Associate (80%) - remote

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15636en
  1. Contract
  2. English
  3. Associate
  4. Legal, Regulatory & Compliance
  5. Bern
  6. Healthcare & Life Sciences

Skills

Communication skills, labeling, RIMS, Trackwise

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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 80% 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 GCC-related 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

What’s an offer?
The possibility to implement ideas and make a difference in an international prominent company.

To apply proceed with your application here or contact the recruiter directly at: veronika.vonmentzer@swisslinx.com

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