Manager Global Labeling - Oncology

USA, Maryland, Gaithersburg
23 Feb 2021
23 Mar 2021
Full Time
Contract Type
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 inspired at work. We are dedicated to creating 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 Manager) provides regulatory labeling expertise to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET) and cross functional Product Labeling teams, with guidance from the Global Labeling Director. This individual contributes to the development of the labeling strategy and is responsible for the maintenance and implementation 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.

  • 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.
  • Contributes to the development of the labeling strategy, in line with the overall regulatory strategy for the product, applying knowledge and understanding of labeling regulations, guidance and competitor analyses with/under guidance from the Global Labeling Director
  • Contributes to 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.
  • Evaluates, interprets and communicates global regulations and trends on labeling and any business impact these might have on product labeling
  • 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.
  • Provides clarity regarding applicable labeling requirements and expectations to relevant partners, including risk insight and proposing mitigations
  • Ensures appropriate communication across Global Labeling Group sub functions
  • Able to justify and communicate the labeling rationale to Senior Leaders to enable effective decision making.
  • Contributes to the development of target labeling documents, as appropriate under the supervision of the Director
  • Assist in the development of labeling policies, procedures and SOPs

Required Skills
  • Bachelor's degree in science or related field
  • 4 plus years of experience, including regulatory experience, preferably working with labeling
  • Knowledge of labeling regulations and guidance
  • 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 distil an issue to its key components and suggest solutions)
  • Interpersonal Awareness (aware of how actions affect other people)

Preferred Background:
  • Advanced academic training is highly desirable (PharmD, PhD)
  • Experience in Labeling development and/or maintenance
  • Knowledge of major markets Labeling regulations

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 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.

Where can I find out more?

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