Global Labeling Operations Manager
Pema People AB / Apotekarjobb / Göteborg
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We are now looking for experienced documentation managers for long-term consultant assignments at AstraZeneca in Gothenburg. With the right profile and a lot of passion, this might be the start of a fruitful employment at Pema Engineering & Science.
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 submissionInterpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate.
• Interact with Marketing Company colleagues regarding global artworks as appropriateMaintain repository of current labeling documents, including appropriate website repositories
• Process and prepare all US Final Printed Labeling and required EU specimens for submissionAssist 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 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
Are you the perfect match?
If you have any questions regarding the assignment, please contact Business Area Manager, Karin Lyckemalm at
karin.lyckemalm@pemapeople.se .
You apply by register below and attach CV and cover letter.
Last applicxation day is 2016-02-25, however selection is done continuously.
We are looking forward to receiving your application and wish you a splendid day!
Pema People AB is staffing and recruitment Company that has been active since 1997. Pema People AB is a company in constant development and since 2016 we are present in Gohenburg. We match the best people to interesting companies and assignments. We offer our employees maximum experience in short time.
Pema Engineering & Science has extensive experience from both staffing and science. You can feel Confident in that we understand your business and the challenges you may face. We offer our staff a unique and solid employment solution, which forms the basis for a long-term cooperation.
Varaktighet, arbetstid
Heltid Duaration of the assignments is 12 months. Pema Engineering & Science offer permanent employment for choosen candidates
Publiceringsdatum2016-02-18ErsättningFixed monthly salary
Så ansöker duSista dag att ansöka är 2016-03-25
Ansöker gör du genom att använda länken nedan.
Klicka på denna länk för att göra din ansökanKontaktKarin Lyckemalm, Affärsområdeschef PEMA Engineering & Science 0720-808934
karin.lyckemalm@pemapeople.seFöretagPema People AB
AdressPema People AB
Ektorpsgatan 6
60337 Norrköping
KontorsadressEktorpsgatan 6
Övriga kontaktuppgifter Jobbnummer 2679010
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