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 will be responsible for overseeing the submission and implementation of labeling changes across regional and local product information and packaging.

**Responsibilities**

**Project Management**:

- Lead and manage assigned global projects with labeling impacts.
- Monitor the implementation of labeling changes worldwide.
- Interface with stakeholders to implement approved labeling variations into electronic or printed package materials.

**Global Collaboration**:

- Support foundational markets (Australia, Switzerland, Germany, EU, and US) by providing labels to GRA Region and ROW for NDAs, renewals, CPPs, and labeling verification statements.
- Collaborate with functional SMEs on vaccines Annual Strain Update (ASU) pre
- and post-activities.

**Labeling Assessment and Compliance**:

- Coordinate and implement labeling assessments in RIMS and Trackwise systems for global labeling changes.
- Support pre
- and post-submission labeling activities for foundational markets.
- Coordinate GCC-related activities, including RA Assessment and LCI collaboration.

**Quality Assurance**:

- Ensure first-time quality and compliance in all aspects of labeling.
- Deliver detailed packages in a timely manner.

**Manuscript Management**:

- 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 packages to EU- and US-dependent markets.

**Collaboration with EU-GRA Lead**:

- Collaborate in coordinating labeling activities for EU CP/MRP/DCP submissions.
- Assist in linguistic review and national translations.

**Support to GLO Strategy Team**:

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

**Your Profile**

Bachelor's or Masters or PhD degree in a relevant field, as.

proven experience in pharmaceutical labeling and regulatory affairs.Strong project management skills with a track record of successful global project delivery.Strong knowledge of relevant regulatory guidelines and requirements within Switzerland, Germany, EU, Australia and US markets.
-Excellent communication skills in English, and German C1/C2 and/or Swiss German is highly advantageous, the same with additional languages.

**Benefits**

Competitive salary.

Remote work flexibility.
-Multicultural environment

**Contact**

**About Us**

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