Summary: Responsible for generating tools and content to build data functionality supporting CMC Regulatory Sciences processes. Participates in CMC Regulatory Sciences processes and standardization initiatives. Monitors CMC Regulatory Sciences metrics to identify gaps in current processes, improve service levels to internal and external customers, reduce waste, and improve planning efficiency.
Essential Duties and Responsibilities may include, but are not limited to, the following:
- Perform data analysis to design and build ways to consolidate data associated with regulatory submissions and provide oversight of systems that facilitate global submission visibility.
- Support CMC Regulatory Sciences systems through the development of databases and/or utilization of data entry forms and reports (potentially combined with Excel based workbooks and charts) to:
- Design and build user friendly interfaces to allow users to efficiently upload/input all submission planning and response information.
- Build and/or interpret queries and reports to provide ready-to-use Excel / Powerpoint friendly information from Microsoft Access.
- Support CMC Regulatory Sciences teams to incorporate these queries and reports into day-to-day planning, scheduling, monitoring and reporting needs.
- Build ad-hoc queries and reports to gather and present information effectively to support resolution of urgent CMC Regulatory Sciences issues.
- Design novel Excel models, tools and templates by leveraging advanced formulae and programming (VBA, SQL).
- Develop analytics to identify and improve reporting/planning/staffing efficiencies.
- Develop and administer SharePoint sites to allow access to the routine reports and ad hoc information requests for all stakeholders.
- Develop and track metrics to measure the timeliness, accuracy and integrity of data from stakeholders. Align across teams to improve reporting integrity.
- Provide support and tool or subject matter expertise to develop additional databases / reports. Document user requirements associated with development.
- Build front end applications to SQL Server databases for end user data entry and record management.
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