Associate Director, Regulatory Information Management Analytics and Reporting
Location: Cambridgeshire, Cheshire East
Job Type: Full time
Do you have expertise in, and passion for data analytics and visualization, science and artificial intelligence? Would you like to apply your expertise to make an impact 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.
Global Regulatory Operations
We are now looking for a Regulatory Information Management (RIM) Analytics and Reporting Associate Director to join us in Global Regulatory Operations (GRO) within Regulatory Affairs. This is a growing area within a globally connected business, and a place to share learnings and best practices with our leading Regulatory specialists. Working across our locations, therapy areas and external community means we’re comfortable stepping up, willing to take ownership of our work, in an effort to find solutions for the business and our personal career development.
The jobholder will be a member of the RIM Analytics and Reporting group, which is specifically tasked with providing analytical and reporting services in support of the Regulatory Affairs business. With a specific focus on regulatory compliance and data quality, data science and innovative development of systems and tools, the RIM Analytics and Reporting team is accountable for maximising the business value of our RIM data.
What you’ll do
As a member of the RIM Analytics and Reporting team you will be responsible for the development and maintenance of reports and dashboards, as well as providing ad hoc expertise and advice in support of regulatory partners. Ensuring delivery of analytical and reporting services in support of the Regulatory business with a specific focus on regulatory compliance and data quality. By combining an understanding of business unit requirements, an understanding of the range of available data/information assets, and the in-depth analytical expertise that is critical to effective exploitation of these assets.
You will be driving innovation and strategic development of analytical solutions that address business future challenges and needs, ensuring Regulatory business can gain full value from the available information to enable compliance and deliver competitive advantage. By providing critical information in support of: business strategy and performance, enterprise-wide regulatory compliance tracking, data quality improvement, externalisation, benchmarking, trend analysis, process improvements and decision support.
With this in mind we think you have a robust understanding of regulated procedures, systems and data, and an ability to interpret, integrate and present complex data analysis to a broad range of customers, preferably in the Pharmaceutical industry.
Specific responsibilities can include:
Data model design in relation to the analytics platform with respect to the Veeva Enterprise Regulatory Vault (ERV) implementation, including query and report optimisation.
Change Management of the analytics platform, with respect to ERV, including impact assessments on the Oracle data model and existing reports, GxP documentation changes and the development and execution of system test scripts.
Development of data integration workflows using ETL platforms such as Informatica and\or SnapLogic.
Rapid development of tactical solutions to solve acute business problems, such as data quality or compliance issues using Oracle APEX (Application Express), MS Power Apps or similar “low code” frameworks, including advanced PL/SQL scripts.
Maintenance and development of existing portfolio of reports/dashboards and KPIs across various technical platforms (Spotfire, Oracle APEX, Excel VBA, Python), providing continuous improvement and customer support.
Education, Qualifications, Skills and Experience
Essential for the role:
Bachelor’s/Master’s degree or equivalent qualification in scientific or computer science discipline.
Experience from working in a regulated environment with proven ability of interpreting and integrating complex data sets and communicating them effectively.
Data visualisation experience, ideally with Tibco Spotfire and/or Power BI.
Experience from data integration using ETL tools, ideally with SnapLogic and/or Informatica.
In-depth knowledge of data model design and SQL, preferably in an Oracle environment (PL/SQL).
Highly developed conceptual and analytical thinking, with ability to understand multiple, sophisticated business needs, and convert these requirements into data products.
Desirable for the role:
Experience from working with data quality and compliance initiatives within a regulated environment.
Experience from working with Veeva Vault solutions, including its configuration and data model.
Understanding of the procedures, processes and standards governing the submission and exchange of electronic information (documents and data) with health authorities worldwide, including familiarity with regulatory data-driven initiatives such as EVMPD and IDMP.
Experience in using artificial intelligence (e.g. ML, NLP) to enable analytics services and interpreting complex data sets.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial 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?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save plans, A performance recognition scheme and a competitive, generous remuneration package.
Where can I find out more?
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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.