Labeling Delivery Assistant at AstraZeneca Gothenburg
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma is looking for a competent and experienced Labeling Delivery Assistant for a consultancy assignment at AstraZeneca in Gothenburg.
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
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 ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-11-14ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-11-21
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4458574
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