Global Labeling Operations Manager to AstraZeneca
Experis / Marknadsföringsjobb / Göteborg
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hela Sverige Experis Engineering team are growing and we are now looking for you with a University Degree in Science or related discipline with 3 to 5 years pharmaceutical experience, preferably regulatory experience and preferably working with labelling. You also need to have excellent knowledge in both English and Swedish language for the job as Global Labeling Operations Manager/Associate Director at AstraZeneca, Gothenburg.
About AstraZeneca
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We're inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines - strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You'll be part of a team that's rolling back the frontiers of science to turn yesterday's impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients - and in return, we'll help you develop way beyond what you thought possible.
The Arena
The Global Labeling Group (GLG) is part of Global Regulatory Affairs and focuses on both the preparation and maintenance of labelling 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.
The group is now looking for a Global Labeling Operations Manager/Associate Director, on a temporary basis for one year. The Global Labeling Operations Manager/Associate Director is responsible for the regulatory role in support of EU and US labeling submissions including managing the EU linguistic review process and authoring content of labeling for US SPL submissions.
The role
* Manage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents and coordinate review and approval of final submission
* Oversee EU translations process as appropriate
* Interact with appropriate functional groups to obtain labeling annotations and supporting documentation
* Author/Coordinate Content of Labeling/Drug Listing SPL generation and review
* Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents
* Understand industry labeling trends related to packaging and labeling implementation, reviewing competitor and other labeling
* Originate precedent searches, create and maintain labeling comparisons and assist in analysis of competitive labeling
Minimum experience
* University Degree in Science or related discipline
* 3 to 5 years pharmaceutical experience, preferably regulatory experience, preferably working with labeling
* Knowledge of labeling regulations and guidances
* Keen attention to detail and accuracy
* Excellent verbal and written communication skills
* Experience in packaging labeling development is highly appreciated but is not a requirement.
What we offer our consultant
As a consultant at Experis, we offer you the opportunity to develop your skills on behalf of some of the largest companies in several different industries. We have high expectations of you, but in return we offer excellent development and career opportunities. Here you also get a development plan, so both you and your consultant manager understands what you want to achieve and which skills you want to develop.
Our consultants have a secure job with all that implies in terms of overtime, vacation, pension and insurance under the collective agreement.
Application
Unfortunately, we can not receive your application by email, but apply through the application field through this advertisement, Please enter when you can be available and how you solve housing if you don 't live in the area were we are looking for candidates. The selection process is ongoing, so it's important that you submit your application as soon as possible.
If you have questions regarding the consultancy role you are welcome to email Candidate Specialist Julia at .
Welcome with your application!
Varaktighet, arbetstid
Heltid Contract
Publiceringsdatum2017-06-27ErsättningEj angivet
Så ansöker duSista dag att ansöka är 2017-07-11
Ange följande referens när du ansöker: 25192
Klicka på denna länk för att göra din ansökanKontaktJulia Järvholm
Julia.Jarvholm@se.experis.comFöretagExperis
AdressExperis
40423
40423 1480
KontorsadressLilla Bommen 5A
Jobbnummer 3577137
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