Beschreibung
The Senior Project Manager / Business Analyst will be heading the R&D "ELDORADO Successor" project. The project aims at replacing the current R&D Document Management System and is run from Global Regulatory Affairs Operations, team Regulatory Application Solutions & Data Mgmt., which is at the interface between IT and Regulatory business.In Step 1, the project replaces the basic functionality of the existing system (already ongoing; planned Go-Live in Q1/2018), while in Step 2 additional, advanced usability improvement features as well as the interface to the Submission Mgmt. system will get into focus.
He/she will work with internals and externals from Business (various R&D departments), Business Technology (IT) and vendors and drive the Implementation and Go-Live phase of Step 1. For Step II, he/she drives all phases from Analysis (User Requirements and Use Cases) to Configuration to Change Management (Training) and Go-Live. He/she also ensures that all configuration and implementations are in line with existing and upcoming regulations such as eCTD4, SPOR/IDMP, CFR 21 Part 11, ICH E6.
Main tasks and responsibilities:
* Develops, tracks, ensures and executes detailed work plans, schedules, project estimates, resource plans, status reports and budgets
* Drives the Implementation and Go-Live phase of Step 1
* Drives all phases of Step II, from Analysis (User Requirements and Use Cases) to Configuration to Change Management (Training) and Go-Live
* Works closely together with various project and governance bodies (i.e. Core and extended project team; Steering Committee, Operational Committee)
* Partners with stakeholders in R&D and internal functional groups (Business Technology, Quality Assurance, etc.) to coordinate project deliverables and to meet project objectives
* Partners with vendor to manage vendor deliverables
Qualification Requirements
* At least 5 years project management experience of Regulatory IT projects in Pharma Industry
* Track record in regulatory Document Mgmt. Systems
* Sound understanding of Submission Management
* Experience managing project teams
* Good understanding of Computer System Validation (GxP) and awareness of relevant regulations and laws
Desired Characteristics
* Excellent verbal and written communications skills
* Experience in change management
* Leadership personality