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

Profile/Experience:

Ideally scientific Bac + 5 (Pharmacist, engineer or master in science) with at least 3 years of experience in AR and knowledge or appetite for tools

Professional skills:

– Regulatory knowledge (international registration procedures, European and ICH guidelines, IDMP, EUDAMED etc …)

– Work according to the quality and safety criteria defined in the company

– Fluent Professional English (TOEIC score > 850)

– Mastery of computer tools related to the activity

– Proficiency in Word, Excel, PowerPoint and Adobe Acrobat software

– Ability to organize and rigorously in an international environment

– Management of the priorities of the activities in agreement with its Manager

– Autonomy, initiative and sense of responsibility

– Relational fluency, working in multidisciplinary and international teams

– Capacity for innovation, creation and imagination

– mastery of software such as Ennov Dossier, eCTD manager and/or regulatory databases such as Ennov, Register or Veeva is a plus