Global Labeling Operation Managers to AstraZeneca in Mölndal!
Adecco Sweden AB / Läkarjobb / Mölndal
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hela Sverige Do you have knowledge or experience of labeling regulations and guidances? Are you a person with an eye for detail and accuracy? Are you a critical information seeker who enjoys building relationships and have a natural ability to think strategically? Then this assignment might be what you are looking for! We are now recruiting Labeling Operation Managers to AstraZeneca in Mölndal. These one year consultant assignments are planned to start as soon as possible and proceed for one year.
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) 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 two Labeling Operations/Associate Directors, on a temporary basis, who are responsible for the regulatory role as part of the labeling process, each dealing with one aspect of GLG responsibilities, please see below.
• In the document management role, the focus will be to deal with preparation and formatting of labeling documents for submissions to Health Authorities, file managing and archiving in designated databases, translation preparation and process (linguistic review within EU).
• In the packaging and artwork role, the focus will, include 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.
• Manage labeling submissions for US and EU, including Quality Check, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission.
• Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate.
• Interact with Marketing Company colleagues regarding global artworks as appropriate.
• Maintain repository of current labeling documents, including appropriate website repositories.
• 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.
Minimum Requirements
• 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 an 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.
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.
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.
If you have any questions regarding the position please contact Heidi Pettersson,
heidi.pettersson@adecco.se .
We look forward to your application!
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2016-02-18ErsättningFast lön
Så ansöker duSista dag att ansöka är 2016-02-24
Ansöker gör du genom att använda länken nedan.
Klicka på denna länk för att göra din ansökanKontaktFrida Hallström
Frida.Hallstrom@adecco.seHeidi Pettersson
Heidi.Pettersson@adecco.seFöretagAdecco Sweden AB
AdressAdecco Sweden AB
Kungsgatan 60
10224 STOCKHOLM
KontorsadressKungsgatan 60
Övriga kontaktuppgifter Jobbnummer 2679544
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