Associate Director II, Regulatory Information Management Analytics and Reporting

Job Description

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 stakeholders. 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 andor 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 ExperienceEssential for the role:Bachelors/Masters 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.,

Keyskills :
financeadvisorycompliancereporting