Global Labeling Associate

vor 1 Tag

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 GCC-related 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 US-dependent 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 multi-market 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 post-marketing requirements.
- Strong scientific background and ability to understand and interpret scientific documents and concept with the ability to translate them into labeling content
- Demonstrated problem-solving 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 cross-cultural exposure. Experience collaborating in a complex and matrix environment is required.
- Proficient regulatory and drug/biologic development (pre-clinical to post-clinical) 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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