Mainactivities and responsibilities :
RIMS/IDMP :
Be the QA /AR tools transformation project manager
Be the Regulatory Referent for the subject RIMS (Regulatory Information Management System)/IDMP
Participate in collaboration with the Project team in the identification of the future RIMS/eDMS solution (through a call for tenders): active participation in the analysis of RIMS solutions and the selection of the final editor,
Ensure reporting on the progress of the project, identify and characterize risks. Be able to propose remediation plans
Organize transversal workshops in order to collect the need and raise awareness among the contributing functions.
Ensure the completeness of the URS and in particular the data necessary for the implementation of the RIM solution
Provide training aroundthe IDMP repository
Participation in collaboration with AQ/IT and the AR teams in the deployment of the RIMS/eDMS project within the group (planning, data migration, test phase, validation, …)
MASTER DATA :
Contribute to the master data initiative in cooperation with IT
En link with IDMP/EUDAMED define the data to be included in the master data initiative and establish the governance for each of these data
Administer/Co-Administer the future RIMS
Define the processes to be covered in the RIMS/eDMS project
Lead the development ofregulatory processes related to the implementation of IDMP/EUDAMED standards
Write the procedures inherent to the activity
Set up the monitoring of indicators related tothe x activities (Metrics, KPIs…)
Be actively on standby around topics related to IDMP/EUDAMED and be able to share and synthesize news