Global Labeling Associate

Vor 2 Tagen

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)

  • Global Labeling Associate

    vor 2 Wochen

    Bern, Bern, Schweiz Swisslinx Vollzeit

    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...

  • Global Labeling Associate

    Vor 2 Tagen

    Bern, Schweiz Swisslinx Vollzeit

    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...

  • Global Labeling Associate/ Global Regulatory

    vor 4 Wochen

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...

  • Global Labeling Associate

    vor 2 Wochen

    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...

  • Global Labeling Associate/ Global Regulatory

    vor 2 Wochen

    Bern, Bern, Schweiz We make it Vollzeit

    Beschreibung:We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience.Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places...

  • Global Pharmaceutical Labeling Solutions Associate

    vor 2 Monaten

    Bern, Schweiz Adecco Vollzeit

    We are seeking a highly skilled and motivated professional to join our renowned client's team as a Global Pharmaceutical Labeling Solutions Associate. This temporary position offers a unique opportunity to contribute to global projects in the pharmaceutical industry, all while enjoying the flexibility of a remote work setup. As a key player in our team, you...

  • Global Pharmaceutical Labeling Solutions Associate

    vor 4 Wochen

    Bern, Schweiz Adecco Vollzeit

    We are seeking a highly skilled and motivated professional to join our renowned client's team as a Global Pharmaceutical Labeling Solutions Associate. This temporary position offers a unique opportunity to contribute to global projects in the pharmaceutical industry, all while enjoying the flexibility of a remote work setup. As a key player in our team, you...

  • Global Labeling Associate

    vor 4 Wochen

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...

  • Director, Global Labeling Data Strategy Lead

    vor 3 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    As a member of the GL leadership team, the director, GL data strategy and team assess and communicate the impact of key clinical endpoints on a future label. You will influence by articulating how agency advice and precedence and the competitive landscape support or require modifications to the design to deliver desired label outcomes. The position then maps...

  • Associate Director, Global Feasibility

    vor 2 Wochen

    Bern, Bern, Schweiz CSL Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 4 Wochen

    Bern, Schweiz CSL Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 4 Wochen

    Bern, Bern, Schweiz CSL Behring AG Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 1 Monat

    Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 2 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery.The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 4 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 4 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 4 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery.The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 4 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global EHS Manufacturing

    vor 3 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    The role of the Associate Director, Global EHS Manufacturing is to** **develop and implement programs and plans to manage EHS risks associated with manufacturing operations. Ensuring compliance with laws, regulations and company policies. Specialized focus on development, deployment and support of core technical EHS processes and standards. You will...

  • Associate Director, Global Critical Safety Systems

    vor 3 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    The Associate Director, Global Critical Safety Systems is accountable for development, deployment and governance of core technical environment, health and safety (EHS) processes and standards across all CSL/Seqirus units. You will help ensure global program understanding, and implementation. You will collaborate as part of the Global EHS team, reporting into...