Global Labeling Operations Manager, AstraZeneca
Poolia Väst AB / Apotekarjobb / Mölndal
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On behalf of our client AstraZeneca we are now looking for a Global Labeling Operations Manager, The mission will start in the beginning of March or after agreement where the right consultant will be extended or hired after 12 months.
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
If you are interested, 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 Labeling Delivery Packaging/Artworks Manager, on a temporary basis. 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:
• Point of contact for Regulatory Affairs towards the process for the creation, approval, and implementation of commercial printed labeling in collaboration with various functions
• Coordinates and/or leads cross-functional teams in the development and lifetime maintenance of the US, EU and other regional packaging component labeling for all commercial products
• Provide tactical and strategic guidance to product labeling teams regarding placement and regulatory requirements for regional packaging component labeling content and design
• Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate
• Interact with Marketing Company colleagues regarding global artworks as appropriate
• Process and prepare all US Final Printed Labeling and required EU specimens for submission
• Assist Global Labeling team in resolution of labeling issues as needed
• Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function
• Assist in other regulatory activities as required
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 in English is necessary.
• Good skills in verbal and written Swedish is appreciated but is not a requirement.
• 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.
Sluttext
If you are interested, apply now!
Language
en-GB
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-02-24ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-03-06
Ange följande referens när du ansöker: 45910
Klicka på denna länk för att göra din ansökanKontaktJenny Lundkvist
jenny.lundkvist@poolia.seFöretagPoolia Väst AB
AdressPoolia Väst AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 3340022
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