Global Labeling Operations Manager at AstraZeneca
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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hela Sverige Global Labeling Operations Manager
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 consultant assignment
The arena
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. They're inspired by what science can do. Driven by the desire to meet unmet patient needs in their core therapeutic areas. Bold in their thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, they bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines - strengthening they're product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
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 Global Labeling Operations Manager/Associate Director, on a temporary basis for one year. The Global Labeling Operations Manager/Associate Director is responsible for the regulatory role in support of EU and US labeling submissions including managing the EU linguistic review process and authoring content of labeling for US SPL submissions.
The role
• Manage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents and coordinate review and approval of final submission
• Oversee EU translations process as appropriate
• Interact with appropriate functional groups to obtain labeling annotations and supporting documentation
• Author/Coordinate Content of Labeling/Drug Listing SPL generation and review
• Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents
• Understand industry labeling trends related to packaging and labeling implementation, reviewing competitor and other labeling
• Originate precedent searches, create and maintain labeling comparisons and assist in analysis of competitive labeling
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
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: 2017-07-02, however interviews will be performed continuously so please send your application as soon as possible.
More information: Eleonor Ehrman +46733434109 or Alma Zanqrelle +46761440727
alma.zanqrelle@dfind.se [ mailto:
alma.zanqrelle@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 over 40 countries Randstad is the work second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2017-06-26ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-07-06
Ange följande referens när du ansöker: 201063985
Klicka på denna länk för att göra din ansökanKontaktalma.zanqrelle@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 3574571
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