Beschreibung
Task:The Senior Project Manager / Business Analyst will be heading the Regulatory Information Management System Enhancement Project. The Senior Project Manager will work with internal/external Regulatory Business, Vendor (Software) and Business Technology (IT) teams to lead, define, coordinate and implement the solutions based on business objectives.
* Develops, tracks, ensures and executes detailed work plans, schedules, project estimates, resource plans, status reports and budgets
* Partners with Regulatory Affairs groups (Application Solutions, Data Management & Quality, Validation) to coordinate project deliverables and to meet project objectives
* Partners with vendor to manage vendor deliverables (with involvement of MSA and SOW negotiations)
* Partners with internal functional groups (Business Technology, Quality Assurance, Procurement etc) to coordinate project deliverables and to meet project objectives
Requirements (Must have):
* BS in Engineering, Computer Science, Mathematics or demonstrated equivalent skills and experience.
* Minimum of 5 years of IT Project Management in Pharma Industry
* Good understanding of Computer System Validation (GxP)
* Knowledge of the processes and systems in Global Regulatory Affairs
* Liquent InSight (incl. Analytics)
* XEVMPD
Environment/Miscellaneous:
Utilization: 4-5 days per week / 50% on site
English CVs
Beginn: 03.04.2017
Dauer: 31.12.2017
Branche: Chemie/Pharma