Associate Director for Global Labeling - Oncology
- Experience Level
- Experienced (non-manager)
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, 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.
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and encouraged at work. We are dedicated to crafting a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while growing collaboration between teams.
The Global Labeling Strategy Associate Director provides regulatory labeling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labeling Teams (PLT). This individual leads the development/implementation of the labeling 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. The individual contributes to the Development of the labeling group by sharing knowledge and mentoring peers.
- Ensures that the labeling process is followed through the lifecycle of the product.
- Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
- Leads the development of the labeling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analysis, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.
- Leads the PLT in the preparation and maintenance 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 labeling.
- Leads the development of labeling negotiation strategies, anticipating HA perspectives.
- Provides labeling 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 labeling regulations and guidance.
- Provides clarity regarding applicable labeling requirements and expectations in complex situations to relevant partners, including risk insight and proposing mitigations
- Evaluates, interprets and communicates global regulations and trends on labeling and any business impact these might have on product labeling
- Ensures appropriate communication across Global Labeling Group sub functions
- Able to explain and communicate the labeling rationale to Senior Leaders to enable effective decision making.
- Leads the development of target labeling documents as appropriate
- Assist in the development of labeling policies, procedures and SOPs
- Bachelor's degree in science or related field
- 6 plus years of experience, including regulatory experience, preferably working with labeling
- Knowledge of labeling regulations and guidance
- 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 handle risk
- Must demonstrate proficiencies in:
- 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 distill an issue to its key components and suggest solutions)
- Interpersonal Awareness (aware of how actions impact others)
- Advanced academic training is highly desirable (PharmD, PhD)
- Experience in Labeling development and/or maintenance
- Knowledge of major markets Labeling regulations
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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.
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