Global Labeling Associate Director
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
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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.
As the Global Labelling Associate Director, you 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. You will be contributing to the Development of the labelling group by sharing knowledge and mentoring peers.
What you’ll do
- Ensures that the labelling process is followed through the lifecycle of the product.
- Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
- 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.
- 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.
- Manages the development of labelling negotiation strategies, anticipating HA perspectives.
- 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 labelling regulations and guidances.
- Provides clarity regarding applicable labelling requirements and expectations in sophisticated situations to relevant partners, including risk insight and proposing mitigations
- Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling
- Ensures appropriate communication across Global Labelling Group sub-functions
- Able to support and communicate the labelling rationale to Senior Leaders to enable effective decision making.
Minimum Requirements
- University Degree in Science or related field
- 3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labelling
- Knowledge of labelling regulations and guidance
- Excellent verbal and written communication skills
- Keen attention to detail and accuracy
- Multi-cultural awareness and sensitivity
- Ability to assimilate clinical and scientific information and present it in a concise manner
- Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
Preferred
- Experience in Labelling development and/or maintenance
- Knowledge of major markets Labelling regulations
- Advanced academic training is highly desirable (PharmD, PhD)
Skills
- 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 impact other people)
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- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
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- Learn more about working with us in Canada
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Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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