Global Pharmaceutical Labeling Solutions Associate - Bern, Schweiz - Adecco

Adecco

Geprüftes Unternehmen

Bern, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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 GCCrelated activities, including RA Assessment and LCI collaboration.

Quality Assurance:

Ensure firsttime 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 USdependent 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 multimarket 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.