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Global Regulatory Affairs Documentation and Learning Officer

Global Regulatory Affairs Documentation and Learning Officer

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Global Regulatory Affairs Documentation and Learning Officer

  • Location:

    Belgium

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Yuan Xie

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    Yuan.Xie@msipharma.com

  • Job ref:

    VR/04081_1678895786

  • Published:

    about 1 year ago

  • Startdate:

    ASAP

Please find below a brief description of the role:

Start date: ASAP

Duration: 6-month initial contract (with potential to extend)

Location: Anderlecht, Belgium

Language: English

Key Job Functions:

LEARNING

  • Entirely review GRA training matrices (inc. IT GRA systems matrices)
  • Set-up a training matrix in line with GRA, LRA (Local Regulatory Affairs), and learning needs of strategic partners
  • Provide statistics and dashboard regarding GRA training matrices and compliance
  • Regular maintenance of GRA training matrices
  • Primary point of contact for GRA staff qualification requests


DOCUMENTATION

  • Support SMEs to ensure quality output for documentation creation and revision (metadata, template to be used, best practices)
  • Determine fit-for-purpose documentation structure and tools for controlled documents within or outside Source CD system
  • (Re)-emphasis of good documentation writing practices to increase quality of documentation
  • Supporting compliance operations impacting documentation & learning
  • Provide statistics and dashboard regarding GRA documentation landscape