Regulatory Business and Compliance Analysis Associate Director

Do you have expertise in, and passion for data analytics and visualization, science and artificial intelligence?

We are now looking for a Regulatory Business and Compliance Analysis Associate Director to join us in Global Regulatory Operations (GRO) within Regulatory Affairs.

This position will be a part of the Business and Compliance Analytics (B&CA) group, which is specifically tasked with providing analytical and reporting services in support of the Regulatory business, with a specific focus on regulatory compliance and data quality, data science and innovative development of systems and tools.

What you'll do
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 stakeholders, ensuring delivery of analytical and reporting services in support of the Regulatory business, with a specific focus on regulatory compliance and data quality as well as strategic-enabling support to Global Regulatory Operations (GRO) and its wider enterprise stakeholders.

You will also be driving innovation and the deployment of analytical solutions that address business challenges and needs, ensuring Regulatory business can gain full value from the available information to enable compliance and deliver competitive advantage. You do this 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.

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Data model design in relation to the analytics platform with respect to the Veeva Enterprise Regulatory Vault (ERV) implementation, including query and report optimisation and data compliance
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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
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Development of data integration workflows using technical platforms such as Informatica and\or SnapLogic and Talend
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Development of tactical solutions to solve acute business problems, such as data quality or compliance issues using Oracle APEX (Application Express) or similar "low code" frameworks
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Development of advanced SQL (preferably Oracle) and PL/SQL scripts to respond to business requirements
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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
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key performance metrics, internal and external benchmarks, compliance and data quality issues, as well as responding to ad hoc business requirements, including requests in support of health authority inspections
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Provide data modelling expertise, specifically with a view to integrating data across RIMS systems

Essential for the role

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BSc/MSc degree or equivalent qualification in scientific or computer science discipline
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Experience from working in a regulated environment with proven ability of interpreting and integrating complex data sets and communicating them effectively
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Experience from working with data quality and compliance initiatives within a regulated environment
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Extensive data visualisation experience, ideally with Tibco Spotfire
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Experience from data integration using tools such as Informatica and\or Snaplogic
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In-depth knowledge of data model design and SQL, preferably in an Oracle environment (PL/SQL)
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Able to work independently to tackle sophisticated problems, often while working with uncertain assumptions. Analytical thinking.

Desirable

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Experience from working within a regulated environment with an understanding of regulatory data, processes and systems, including experience of RIMS (Regulatory Information Management Systems)
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Detailed understanding of Veeva Enterprise Regulatory Vault (ERV), including its configuration and data model, and other RIMS platforms
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Experience in web development using the Oracle APEX Rapid Application Development platform (or other low code platforms such as PowerApps)
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Understanding of the procedures, processes and standards governing the submission and exchange of electronic information with health authorities worldwide, including familiarity with regulatory data-driven initiatives such as EVMPD and IDMP
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Experience in using artificial intelligence (e.g. ML, NLP) to enable analytics services and interpreting complex data sets

Why AstraZeneca?
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Here you will be trusted and empowered to be the best you can be. Here we thrive in our inclusive, diverse and bold environment.

What's next?
Are you already imaging yourself joining our team? Good because we can't wait to hear from you! We will go through the applications continuously so please apply as soon as possible but no later than January 30th , 2022. We look forward to receiving your application!