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Location

Saclay, 91400 | France

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Job description

The R&D document management department is looking for a service for the activities listed below.
Summary of the role : Within Global Regulatory Affairs to BE responsible for ensuring conformity of Information Systems with good practices, applying Servier group's document management policies and assisting R&D staff within their business processes and ensure that the validation status of the systems is maintained throughout the lifecycle acting as functional administrator and Business Expert.
Team Management : Manage a team and develop people within the R&D Document Management Department, optimize processes, ensure the oversight of the service provider platform in charge of regulatory SI functional administration.
Functional administration of IS systems :
- Functional administration of the documentary databases
- Follow up of issues, suggest improvements (system and process) in collaboration with users representatives
- Management of evolution and releases as Business expert
- Management of the system validation as Business expert
- Writing of SOP and training materials
- Service provider coordination
- Follow-up of the system validation status, and maintain the system documentation up to date
- User assistance and training management
- Support level 2 for IS administration service provider platform
- Present the system under his/her responsibility during GxP inspection
- Participate into the document/data migration preparation in the context of the set up of a EtoE regulatory solution.

Improvement of Business processes : Optimize and improve business process by the use of information systems, in close collaboration with business representatives.
Master data/document management :
- Ensure quality and reliability of the data and documents managed by the Information system. Implement quality by design notion during the conception phase, adapt process to facilitate the use of the system by the business, implement QC and BI reporting.
- Act as data manager : document and implement the data policy defined by the data owner. Profile : Bachelor's degree in Science or related discipline (e.g. engineering, computer science or related field) with experience in a pharmaceutical company. A Master's degree or higher is desirable.

Languages : Business-level oral and written English

Experience : Minimum of 5 years' experience in a similar position of which 1 plus years spent in team management

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Job tags

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Salary