Global Labeling Associate

vor 1 Woche

Bern, Bern, Schweiz CTC Resourcing Solutions Vollzeit
Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.

For their office in
Bern we are looking for a
8-month contract (hybrid) for a:
**Global Labelling Associate

  • 5566 LBD**
    Main Responsibilities:
  • Manage, track assigned global projects with labeling impacts and monitor implementation worldwide.
  • Interface with impacted stakeholders for the maintenance and implementation of approved labeling variations into the electronic or printed package materials
  • Support GLO in providing foundational markets (Australia, Switzerland, Germany, EU and US) labels to GRA Region and ROW for NDAs, renewals, CPPs and request of labeling verification statements.
  • Collaborate and manage functional SMEs on vaccines Annual Strain Update (ASU) pre
- and post
- activities: Northern-ASU and Southern-ASU hemispheres.

  • Coordinate, manage and implement labeling assessment in
    RIMS, and Trackwise system for global labeling changes.
  • Support pre
- and post-submission labeling activities for foundational markets.

  • Coordinate and manage GCCrelated activities; RA Assessment and LCI collaboration with Submission Coordinator and GL Compliance
  • Ensure first time quality and compliance in all aspects of labeling with detailed packages delivered in a timely manner.
  • Manage and distribute English manuscripts for multimarket labels based on EU CP/MRP/DCP
  • Prepare and distribute EU (MRP/CP/DCP) and US Foundational labeling package to EU and USdependent markets.
  • Collaborate with EU-GRA Lead in coordination of labeling activities for EU CP/MRP/DCP submissions (i.e., linguistic review, national translations)

May support GLO strategy team with:

  • Review and assess ROW labels differences (DTT) from core and Foundational dependent market
  • Prepare and distribute Foundational packages to DE and CH dependent markets.
  • Management and distribution of English multimarket manuscripts based on CCDS, DE and CH to dependent markets
  • Prepare and distribute labeling packages to Toll markets / regions

Requirements:

-
_Swiss working/residency permit and/or Swiss/EU-Citizenship required;_:

  • University degree in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering); advanced degree (MSc, PhD or Pharm D) preferred.
  • 5 years of biotech/pharmaceutical industry experience. This is inclusive of 2+ years of labeling/regulatory experience combined with other global responsibility.
  • Knowledge and understanding of principles of regulatory relevant to drug development, global labeling and postmarketing requirements.
  • Strong scientific background and ability to understand and interpret scientific documents and concept with the ability to translate them into labeling content
  • Demonstrated problemsolving ability; able to analyze risk and make appropriate recommendations/decisions.
  • Must work well with others and within global teams with the ability to build partnerships, particularly crosscultural exposure. Experience collaborating in a complex and matrix environment is required.
  • Proficient regulatory and drug/biologic development (preclinical to postclinical) knowledge including an understanding of broad scientific concepts within labeling and their implications across the organization and globally.
  • Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact.
  • Attention to detail, coupled with the ability to think strategically.
  • Fluency in English (verbal and written)

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