Global Labeling Strategy Manager
AstraZeneca Göteborg / Apotekarjobb / Mölndal
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hela Sverige At AstraZeneca, we're not afraid to do things differently. We're building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
The Global Labeling Group (GLG) at AstraZeneca is part of the Global Regulatory Affairs organisation and leads the Product Labeling Teams in development and maintenance of Core Product Information and United States (US)/European Union (EU) Market Product information (MPI) for marketed and pipeline products.
We have a key role in both Global Regulatory Strategy Teams and in Global Regulatory Execution Teams and are key members of various sub teams such as submission teams, response teams, and launch teams.
We interact with a wide range of functions within the AstraZeneca organisation, and collaborate with for instance Regulatory Affairs, Patient Safety, Clinical, Commercial, and Operations functions, as well as with Marketing Company colleagues.
We are now looking to hire Global Labeling Strategy (GLS) Managers to our sites in Gothenburg, Sweden, Macclesfield, UK and Gaithersburg, US.
This is an exciting opportunity for professional growth in areas of drug development, science, and leadership. The Global Labeling Strategy role will put you right at the heart of where science, clinical evidence, regulatory requirements and expert communication come together.
You will be a central connection point and part of merging the results of many years of research into information for the authorities to approve. And at the end of the day provide the best possible information to prescribers and patients.
If you are inspired by the possibilities of science to make a difference and ready to discover what you can do - join us!
If you are interested, apply now!
For more information about the position please contact Sara Ellmark at
sara.ellmark@astrazeneca.comWelcome with your application no later than April 22, 2018.
Want to know more about the sites for this role? Visit our websites:
Gothenburg site:
https://www.astrazeneca.com/our-science/gothenburg.htmlGaithersburg site:
https://www.astrazeneca.com/our-science/gaithersburg.htmlMacclesfield site:
https://www.astrazeneca.co.uk/about-us.htmlAstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Main Duties and Responsibilities
As a Global Labeling Strategy (GLS) Manager you will provide regulatory labeling expertise to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET) and lead the cross functional Product Labelling Team (PLT).
You will contribute to the development of the labeling strategy and lead the
Development and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned AstraZeneca marketed or pipeline products.
Essential Requirements for the role
• University Degree in Science or related discipline
• Relevant pharmaceutical experience, including regulatory experience, preferably working with labeling
• Knowledge of labeling regulations and guidance
• Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
• Ability to assimilate clinical and scientific information and present it in a concise manner to varied audiences
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
Desirable Requirements
• Experience in Labeling development and/or maintenance
• Knowledge of major markets Labeling regulations
• Advanced academic training is highly desirable (PharmD, PhD)
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We're inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines - strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You'll be part of a team that's rolling back the frontiers of science to turn yesterday's impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients - and in return, we'll help you develop way beyond what you thought possible.
Publiceringsdatum2018-03-20Så ansöker duSista dag att ansöka är 2018-04-19
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Göteborg
AdressAstraZeneca Göteborg
Pepparedsleden 1
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
Jobbnummer 4033806
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