Regulatory System Business Analyst
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Title: Regulatory System Business Analyst
Job Description & Responsibilities
The Regulatory Solutions and Project Management team (RSPM) is responsible for the end user support of solutions and the timely delivery of associated technology projects and programs. The Regulatory Solutions sub team provides support for all the technology systems owned and managed by Global Regulatory Affairs. The specific initiative being hired for is the support of data, documents and processes with in the company’s Document Management System, Mosaic. Mosaic is a Documentum based system that utilizes a FirstDoc overlay to apply structure and supporting metadata to the stored content.
In this specific role, the business analyst will provide end user support to the 2000+ system users, support a project to clean up the data housed in the system based on review of active product registrations, and assist in the review of the current processes and provide recommendations for process improvements within the Submission and Information Management team. The business analyst will contribute to the project strategy, preparing documentation according to agreed process, defining planned activities, managing activities to assure goals and objectives are accomplished within prescribed timeframe, budget and to the expected level of quality.
- Delivery of the defined tasks on a major Global Regulatory Affairs technology project.
- Reports back on progress against project plans, schedules and other project deliverables.
- Partners with colleagues in multiple regions.
- Able to identify, manage and propose mitigation for project risks and issues
- Identifies and proposes resolution for issues, escalating them appropriately
- Develops strong relationships with data experts, SMEs, project team members, vendors and partners to ensure the smooth and efficient running of the project
Skills, Experiences, Knowledge
- Significant experience of data or document management initiatives, with both automated and manual approaches
- Experience working in Regulatory environment and more broadly in the pharma industry
- Experience working in Documentum/FirstDoc
- Self-motivated and able to work independently
- Technically literate and able to discuss technical proposals with IT
- Demonstrated ability to multitask in a deadline controlled, complex and highly regulated environment with the need to appropriately prioritize own workload
- Excellent listening, presentation, time management and interpersonal skills to ensure that they can work collaboratively across regions and functions.
- Able to succeed and deliver in an ambiguous and evolving environment