Associate Director, - Regulatory Data Products
Job Type: Full time
Do you have expertise in, and passion for data?
Would you like to apply your expertise to impact the digital transformation of Regulatory submission process in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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.
Within Oncology Regulatory Science Strategy and Excellence (ORSSE) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working across TAs, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. Digital Regulatory ambition is to transform healthcare, powered by digital, science and partnerships, by accelerating our transformation efforts to ensure we demonstrate the best in new technology and groundbreaking capabilities to keep us at the forefront of future drug development.
What you will do :
Reporting to the Senior Director for Data - Digital Health Information Management, you will focus on ensuring that Regulatory Data Products are implemented in line with FAIR and TRUST principles and are governed / controlled to maximize use across the AstraZeneca enterprise.
Your key accountabilities will be:
- Working with key stakeholders in Regulatory, Dev Ops, Digital Health, Commercial, TAs, DS&AI and IT, you will drive the vision and strategy for Regulatory data products.
- You will help liaise across the enterprise, ensuring the right data products are set up for use across AZ
- You will ensure coordination between data platforms, solution architecture, information architecture and data governance so that the final products meet business, technical and regulatory requirements.
- You will need to be able understand and clearly articulate the business value of the products and how they are used by multiple systems and functions across AZ (within and beyond Regulatory).
- You will own the Data Product roadmap and prioritize building what matters most to achieve its strategic goals and initiatives.
- You will own and manage the Data Product’s agile backlog to ensure all consuming systems and products are able to leverage data as needed. This will also include timely reversal of technical debt.
- You will identify and manage partnerships required to ensure innovative capabilities at the intersection of data science, technology and healthcare.
- You will act as a Champion for agile, iterative development process driven by design thinking, frequent end-user input, constant insight generation from data.
- You will manage dependencies in and across releases to complete release phases and milestones.
- You will promote and govern the use of the Data Products across the organisation (so duplicate data flows are not set up)
- You will work with the Data Office and any relevant Data Owners to take on the Data Steward role for the Regulatory data products when needed
- You will identify short and long term resource requirements to effectively implement, govern and control Regulatory data products
Essential Requirements :
- Degree(s) in business and/or sciences, or equivalent. proven experience in the pharmaceutical/medical/healthcare industry, development, research and/or commercial planning, and global coordination roles
- Ability to manage a diverse group of senior stakeholders
- Strong knowledge of which roles within study teams need access to Patient Data during and after clinical trials and how the data is routinely used/handled
- Ability to take business requirements and translate these into technical requirements
- Ability to rapidly grasp concepts and to manage complexity by simplifying it for others and providing clear directions to matrixed IT delivery teams
- Leadership skills, including the ability to solve problems that involve many decision makers, and develop multiple options/recommendations
At AstraZeneca we’re dedicated to being an excellent Place to Work. Where you are empowered to push the boundaries of science and unleash your ambitious spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
- We look forward to hearing from you
- Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Competitive Salary and Benefits
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.