One of our client is looking for a Head of R&D document management.

Group 10
Responsibilities

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.

Group 12
Profile

  • Master’s degree in Science or similar education (e.g. engineering, computer science or related field) with experience in a pharmaceutical company.
  • Minimum of 5 years’ experience in a similar position
  • Expertise in team management
  • Business-level oral and written English
  •  French required

132 - Head of R&D document management