Labeling Delivery Assistant - Poolia Göteborg AB - Apotekarjobb i Göteborg
Labeling Delivery Assistant
Poolia Göteborg AB / Apotekarjobb / Göteborg
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We are now looking for a talented Labeling Delivery Assistant within the Labeling Delivery Packaging/Artworks team at AstraZeneca Gothenburg. The assignment is for 12 months starting in December 2018. If you are interested, apply now!

The Arena
The Global Labeling Group (GLG) at AstraZeneca is part of the Global Regulatory Affairs organisation and focuses on both the preparation and maintenance of labeling documents for prescribing information, patient information and regulatory information on packages for Health Authority approval. We are currently working on products for the EU and US markets.

We now have a temporary position within the Labeling Delivery Packaging/Artworks team,
Regulatory Affairs. The assignment is for 12 months starting in December 2018. The packaging /Artworks Manager is responsible for the regulatory role towards creation of the printed material for products under development, updating of existing artworks for already marketed products, liaising with Marketing Companies in Europe as well as packaging sites within production.

The role
* Ensure all work is performed in accordance with established procedures, regulatory
requirements and GxPs.
* Point of contact for labeling/artwork requests that require market/regulatory approval in EU centralised procedure, such as the creation, approval, and implementation of commercial printed labeling in collaboration with various functions
* Coordinate the development and lifetime maintenance of packaging component labeling for commercial products, including introduction of new packs and new product launches, updates to existing packs
* Provide tactical guidance to product labeling teams regarding regulatory requirements for packaging component labeling
* Interpret EU labeling regulations and guidance, determining company impact and providing comments as appropriate
Essential Requirements for the role
* Master of Science in Pharmacy
* Relevant pharmaceutical experience, preferably including regulatory experience
* Knowledge of labeling regulations and guidance
* Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating in diverse cultures.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity

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Sista dag att ansöka är 2018-11-21
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Poolia Göteborg AB

Poolia Göteborg AB
Kungsgatan 42
41115 Göteborg

Kungsgatan 42


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