Global Labeling Operations Manager
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
Observera att sista ansökningsdag har passerat.
Visa alla apotekarjobb i Göteborg,
Mölndal,
Partille,
Kungälv,
Lerum eller i
hela Sverige Visa alla jobb hos Dfind Science & Engineering AB i Göteborg,
Mölndal,
Partille,
Kungälv,
Öckerö eller i
hela Sverige Regulatorisk specialist, läkemedelsbranschen
We are currently looking for two Labeling Operations Managers for consulting assignments at Global Regulatory Affairs, AstraZeneca.
Business: Dfind Science & Engineering
City: Göteborg
Employment: Full time
Last date of application: 2016-02-25, however, interviews will be performed continuously so send your application as soon as possible.
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 two Labeling Operations/Associate Directors, 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 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
For information: Birgitta Nyström,
birgitta.nystrom@dfind.se [ mailto:
birgitta.nystrom@dfind.se ] or Eleonor Ehrman,
eleonor.ehrman@dfind.se [ mailto:
eleonor.ehrman@dfind.se ]
Organisations-/företagsbeskrivning:
Dfind Science & Engineering är ett konsult- och rekryteringsföretag specialiserade på kompetenser inom naturvetenskap och teknik. Med engagemang och lyhördhet hjälper vi människor och företag att hitta lösningar för att utvecklas. Hos oss har du möjlighet att utveckla dina kunskaper och färdigheter genom uppdrag hos våra utvecklings- forsknings- och produktionsintensiva kunder i Norden.
Vi tycker att det är viktigt att all kompetens på arbetsmarknaden tillvaratas. Vi välkomnar alla sökande och eftersträvar mångfald. Dfind Science & Engineering ett auktoriserat bemanningsföretag via Almega och följer deras kollektivavtal.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2016-02-18ErsättningFast lön
Så ansöker duSista dag att ansöka är 2016-02-25
Ange följande referens när du ansöker: 200880903
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 2679047
Observera att sista ansökningsdag har passerat.