Within Oncology Regulatory Affairs, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. As an industry leading Oncology Regulatory function, we’re growing fast and we’re as focused and committed to the development of our people as we are our business – providing an open and supportive space to explore, learn, grow and develop across all roles and levels.

The Digital Technology and Information team for Oncology Regulatory Science and Strategy (ORSS) is responsible for contributing to all digital and technical aspects of the ORSS function along with ORSS digital technology and information lead. The Digital Technology and Information team would support contributions towards developing the digital ORSS strategic roadmap and input to the enterprise wide regulatory information management roadmap;  identification of use cases where AI machine learning algorithms can be applied on Oncology data and oversee implementation of the use cases along with AstraZeneca technology and development groups.

Typical Accountabilities, what you will be doing:

• Supporting contributions along with ORSS digital technology and information lead towards developing the digital ORSS strategic roadmap aspects of the strategic direction of the ORSS team comprised of pipeline teams, data governance, providing input and close collaboration with Regulatory Excellence and the enterprise wide vision and roadmap
• Support the preparation of documentation of an end to end information model (MDM & Information mapping) for Regulatory Information, in close collaboration with relevant regulatory teams.
• Support the enterprise regulatory digitisation of the end to end business process on behalf of ORSS
• Contribute to implementation of ORSS and the enterprise regulatory Governance framework
• Contribute to relationships with Regulatory authorities to develop better insights
• Support identification of use cases where AI machine learning algorithms can be applied and oversee implementation of the use cases along with AstraZeneca technology and development groups.
• Contribute towards ORSS relationship with related technology development groups at AstraZeneca
• Supporting ORSS support in evaluation of new technologies, data assets and other innovative efforts both within and outside of AstraZeneca. These evaluations are in collaboration with Regulatory Excellence and AstraZeneca technical and data specialists.
• Contribute to engagement with Regulatory Excellence and Technology department to identify key data sources of interest to ORSS and maintain a roadmap of future data assets that ORSS should be Findable accessible interoperable and reusable available to its community. This includes assets in the clinical data, and regulatory data and associated late stage development data.
• Support the definition and drafting of new governance guidance and policies as needed, in conjunction with Regulatory Excellence. Support its implementation
• Closely align and partner with one or two of the key internal stakeholder groups  i.e. Regulatory Excellence, Respiratory & Immunology (RIA) and Cardiovascular, Renal & Metabolism (CVRM) Regulatory therapeutic areas, Clinical,  AI and Data group; Enterprise and Data Analytics; AZ2025). Serve as ORSS liaison to those groups and initiatives and ensure alignment with enterprise strategy. Identify with function the need for system enhancements, monitor ensuring delivery of said system enhancements.
• Contribute to ensuring regulatory compliance and Licence to operate across markets
• Drive innovative strategy for emerging technologies pertaining to regulatory informatics
• Accountable for contributions to identification data sources for regulatory specific information for e.g. ORBIS (drug labels, approval summaries, FDA/EMA workshop presentations etc.)
• Contribute to PRO, Information Modelling, Analytics and Automation.

Education, Qualifications, Skills and Experience:

Essential:

• Degree in Life Sciences, Pharmacy, or Medicine or another relevant business discipline
• Previous life science or healthcare experience
• Regulatory consulting scientific background, a depth and breadth of analysing of data
• MDM experience
• Experience of engaging with Regulatory bodies
• Effective project and resource management; proven ability to handle a broad range of customers and team members
• Biopharmaceutical industry experience with demonstrated ability to leverage data and analytics for decision making
• Understanding of analytics landscape in the Pharma/biotech industry
• Understanding of Clinical, Regulatory & Patient Safety  information value chain
• Ability to disseminating complex information to a wide audience

Desirable:

• Previously worked with big data with an ability to derive data insights
• Knowledge of Python or R or related programming languages
• Experience with Waterfall, Agile and Hybrid project management methodologies

Location: Cambridge or Macclesfield, UK, Gaithersburg, US or Warsaw, Poland

Next steps, if the role looks suitable for you please apply!

Date Posted

Closing Date

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.