Supports making data-driven decisions by extracting, validating, interpreting, preparing, and analyzing large amounts of data to deliver high-quality, complex, and timely analytics reporting. These analyses and reports will provide stakeholders with the data they need to make informed decisions in daily operations and strategic planning initiatives.
Should be familiar with data sources and data models from various regulatory systems to build queries, retrieve, transform, load and aggregate data in understandable and usable formats.
Work collaboratively with various stakeholders across GRA and across RD to determine and meet their regulatory analytics needs and is also responsible for assisting in any regulatory reporting on data/metrics as needed.
Work with internal stakeholders to acquire business knowledge regarding the appropriate use of data elements, establish and maintain common business rules, and ensure consistency in reporting across the organization.
This role will be responsible for troubleshooting data integrity issues, analysing data for its completeness and ability to meet business needs, and proposing solutions or recommendations.
This role include includes but is not limited to data exploration and visualization, delivering static and dynamic reports, dashboards, and statistical or predictive analysis tools.
Modification of the existing reports to add additional information and reflect the real time data in the system.
Support Big data/Regulatory Data Objects environments to support the reporting and analytics solutions.
Define and implement data analytics for all the supporting application/Data from RCRIM
Liaise with Health Authorities on data submission topics (e.g. IDMP)
Contributes to define the strategy of the Regulatory Compliance Regulatory Information Management Department
Educate on data literacy for regulatory data
Who you are:
Excellent Analytics and reporting tools background
Excellent RIM database and SQL query background
Good knowledge of current regulatory data standards
Fluent command of spoken and written English
Master’s/Bachelor Degree in life science, pharmacy or pharmacoinformatics, computer science, business/data analytics, business information systems or equivalent field with 6+ years relevant experience.
Passionate for working with data. Not afraid to ask relevant questions to stakeholders.
Prior Knowledge or working experience in Veeva systems is an advantage.
Creates reporting and analytics solutions with appropriate oversight that support the quality and timely delivery of reports and visualizations required.
Proven knowledge of drug development processes and understanding of drug RD departments, e.g., Regulatory Affairs, Biostatistics, Drug Safety, Clinical Operations
Extensive knowledge on technologies and trends related to Research and Development, including big data and advanced analytics.
Prior experience in computerized systems validation (CSV) and testing methodology with awareness of the risks, issues, and activities involved in these processes
Versed in TIBCO Spotfire/Tableau or any other analytical platform and able to incorporate and influence their use in reporting solutions.
Advanced SQL, Data Visualization, Modelling and Wrangling skills.
Strong Customer Facing skills and experienced in training end users of all levels in the use of analytical platforms.
Prior Knowledge of R and Python is an advantage.
Experienced working in iterative and agile working environments.
Leading, influencing, and consulting skills.
Adept at translating business requirements into appropriate reporting and dashboard/ scorecard.
Strong desire and ability to learn, adapt and apply new technologies.
Job specific Competencies Skills
High attention to detail and strong organizational skills, work independently, self-motivated and proactive.
Ability to establish close communications and working relationship with cross functional teams to meet business objectives.
Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements.
Strong negotiating, influencing and interpersonal skills especially regarding indirect people leadership in a matrix organization.
Results-oriented, entrepreneurial and self-motivated.
Goal-oriented, pragmatic, meticulous working style, high attitude to quality.