Global Labeling Operations Manager
Poolia Väst AB / Kemiingenjörsjobb / Göteborg
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On the behalf of AstraZeneca, we are looking for a Global Labeling Operations Manager. The consulting assignment will start in august 2017 and last for one year with the possibility for extension.
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.
If you are interested, please apply now.
Arbetsuppgifter
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
Utbildning/erfarenhet
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
Förmåner
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.
As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
Företagsbeskrivning
Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden's leading pharmaceutical and life science companies. So whether you're interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.
Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you're looking for a world of exciting assignments and new contacts, you'll like being a consultant.
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world's leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Language
en-GB
Varaktighet, arbetstid
Heltid Visstid, mer än 6 månader
Publiceringsdatum2017-06-26ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-06-29
Ange följande referens när du ansöker: 47153
Klicka på denna länk för att göra din ansökanKontaktSatina Sankoh
satina.sankoh@poolia.seFöretagPoolia Väst AB
AdressPoolia Väst AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 3575791
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