Global Labeling Operations Manager at AstraZeneca
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
2017-02-24
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Do you have experience from Regulatory Affairs within the Pharmaceutical industry? We are currently looking for a Global Labeling Operations Manager for a consultant assignment at AstraZeneca.
Employer: Dfind Science & Engineering
City: Göteborg
Extension: Full time
The arena
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 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
Qualifications:
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
Deadline for applications: 3rd March, however interviews will be performed continuously so please send your application as soon as possible.
More information: Birgitta Nyström at
birgitta.nystrom@dfind.se [ mailto:
birgitta.nystrom@dfind.se ]
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in in over 40 countries Randstad is the work second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-02-24ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-03-05
Ange följande referens när du ansöker: 201032951
Klicka på denna länk för att göra din ansökanKontaktBirgitta Nyström
birgitta.nystrom@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 3340073
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