Global Labeling Operations Manager to AstraZeneca!
Adecco Sweden AB / Biologjobb / Mölndal
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hela Sverige Adecco Life Science is now recruiting a Global Labeling Operational Manager to AstraZeneca in Gothenburg. The assignment is a consultant assignment which is planned to start in august of 2017 and proceed for one year. If you are interested we will need your application by the 30th of june so don 't hesitate to apply!
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.
Skills and Capabilities
• Ability to work collaboratively
• Building Relationships (works well across formal and informal networks)
• Negotiation Skills (good listener; able to build a consensus)
• Critical Information Seeking (works well across formal and informal networks)
• Rational Persuasion (able to distil an issue to its key components and suggest solutions)
• Interpersonal Awareness (aware of how actions affect other people)
• Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
What do we offer?
Adecco Life Science is a specialized Business Line within Adecco. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries. As the largest recruiting and staffing company in the world our most valuable assets are our consultants. With us, you as a consultant will be appreciated for your difference-making competence within Life Science!
Adecco Life Science can offer you the opportunity of interesting assignments and positions at attractive companies that perhaps never will be put out on the open market! For your security as a consultant, you are covered by our collective agreement and by insurance and corporate healthcare. We also want you to stay healthy and therefore offer you healthcare contributions and discounts on training cards. We arrange social activities continuously where you are able to share your experiences with our other consultants.
Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
Unfortunately we cannot accept applications through e-mail, but if you have questions regarding the position contact Nalin Yilmaz,
nalin.yilmaz@adecco.seWe look forward to your application!
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-06-26ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-07-01
Klicka på denna länk för att göra din ansökanKontaktNalin Yilmaz
nalin.yilmaz@adecco.seFöretagAdecco Sweden AB
AdressAdecco Sweden AB
Kungsgatan 60
10224 STOCKHOLM
KontorsadressKungsgatan 60
Jobbnummer 3575091
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