Development of a Global PM Department
Opportunity – A mid-size pharmaceutical company expected tremendous growth in their portfolio over a 3-year period. Along with the need to conduct global studies there was a need to develop its Project Management Department to meet this expected growth.
Solution – Implemented a global PM department by developing roles and responsibilities, identifying new business processes, and developing the organizational
structure.
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Implemented A Global Enterprise Management System Opportunity – A pharmaceutical company was having difficulty in managing their portfolio. Timelines/baselines/stage-gate milestones were decentralized and it was difficult to assess project performance and potential NDA/MAA submission dates. Also there were times where opportunity was lost for high priority projects because activities timelines were decentralized.
Solution – Interviewed key stakeholders to conduct a user-owner-stakeholder analysis followed by a gap analysis. An enterprise project management system was implemented with inputs from 3 regions (US, EU, Japan) resulting in one official timeline and project performance objectives. Value to the company was to properly assess future resource requirements, identify competing studies, access delays to potential submission dates, and collection of study metric data for process improvements. |
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Regulatory Agency Marketing Authorization
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