Labelling Strategy Associate Director - Late Cvrm
AstraZeneca AB / Kemiingenjörsjobb / Göteborg
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hela Sverige At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
The Labelling Strategy Associate Director, will provide regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT). This role leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products. This position will have the opportunity to contribute by sharing expertise and mentoring peers.
This role can be based at either of AstraZeneca's dynamic R&D sites in Gothenburg (Sweden), Gaithersburg (US), Macclesfield (UK) or Cambridge (UK).
What You'll Do:
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Ensures that the labelling process is followed through the lifecycle of the product.
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Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
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Interpret regulations, competitor analyses, and anticipating / communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.
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Lead the PLT in the preparation and updates of high quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
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Leads the development of labelling negotiation strategies, anticipating HA perspectives.
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Provides labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional regulations and guidances.
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Provides clarity regarding applicable labelling requirements and expectations in sophisticated situations to relevant partners, including risk insight and proposing mitigations.
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Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling.
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Ensures appropriate communication across labelling sub-functions.
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Support and communicate the labelling rationale to Senior Leaders to enable effective decision making.
Minimum Requirements:
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Bachelor's degree in Science or related field
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At least 3 of pharmaceutical experience, including regulatory experience, preferably working with labelling
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Knowledge of labelling regulations and guidance
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Excellent verbal and written communication skills
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Keen attention to detail and accuracy
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Ability to assimilate clinical and scientific information and present it in a concise manner
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Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
Preferred Qualifications:
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Experience in Labelling development and/or maintenance
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Knowledge of major markets Labelling regulations
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Advanced academic training is highly desirable (PharmD, PhD)
Skills:
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Building Relationships
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Negotiation Skills (good listener; able to build a consensus)
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Critical Information Seeking (works well across formal and informal networks)
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Rational Persuasion (able to distill an issue to its key components and suggest solutions)
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Interpersonal Awareness (aware of how actions impact other people)
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Come and join our journey.
So, what's next!
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Welcome with your application no later than May 8th.
We will review the applications continuously so please apply as soon as possible.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2022-04-11ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2022-05-09
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-135727".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 6529411
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