Deutschland - Sr. Regulatory & Start-Up Coordinator

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We are looking for a Sr. Regulatory and Start up Coordinator to join the Roche/Genentech dedicated RSU team within Global RSU.  Ideally candidates would have either Regulatory and Start-up experience or those who have worked with Roche/Genentech as a Customer directly in the past.   PURPOSE Assist with the delivery of all required regional start-up or global maintenance for selected studies including oversight of the scope of work, budget and resources, under guidance of senior staff.   RESPONSIBILITIES The role holder may be required to cover all the responsibilities mentioned below but will focus on selected activities at any one time, depending on business requirements. This could include being responsible for an individual region or for the global maintenance for several projects.  Assist with the execution of Regional Start Up and/or Global Maintenance for assigned projects in accordance with the agreed RSU strategy.  In a Global Maintenance role:  help to maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan  assist with study maintenance activities such as protocol amendments, Investigational Medicinal Product Dossier updates, addition/removal sites, end of trial submissions.  help ensure continued collaboration across ...

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