freelance
Support in Business/Technical Analysis Reference number: 2136
Last update: 03-12-2021, 14:29
Region: Brussels
Sector: Pharma
Start: 03 Jan 2022    End: 31 Dec 2022
Freelance or Employee
Job description
The mission covers Business and Technical Analysis activities to support the implementation of ISO IDMP (Identification of Medicinal Products) in Europe, as part of the Data Harmonization & Interoperability Program (DHI Program).

The DHI Program is a global Program part of the Company’s Digital Strategy to expand the internal systems to be compliant with ISO IDMP for the EU by 2022, with PQ/CMC in the US, and with similar initiatives in the world. The program also targets the harmonization and interoperability of regulatory data across internal systems, using IDMP as a common language.

Within the DHI Program, the primary activities of the services include data and system readiness for the IDMP implementation in the EU (IDMP Data Remediation & IDMP Submission Tool).
What you’ll do
  • IDMP Data Remediation:
    o Collect information in scope of IDMP Iteration 1 in Europe, which are not available yet within internal systems (e.g. RIM)
    o The information needs to be collected from source documents (e.g. Module 3, SmPCs), in close collaboration with Regulatory Affairs, CMC… departments and under the supervision of the Data Governance Committee
    o The collected information needs to be aligned and harmonized as per IDMP requirements in the EU, and loaded into the relevant source systems
  • IDMP Submission Tool:
    o Contribute to the definition of to-be IDMP submission requirements and processes, to support the selection of a submission tool in line with the objectives of the DHI Program
    o Contribute to the integration of the selected IDMP submission tool in the company landscape
    o Contribute to the implementation of the submission tool, including user acceptance testing, training materials, procedures, running-in, support to end users…
    The mission will be conducted in close relationship with the IDMP Global Business Leads (US- and EU-based), the European IDMP Team, Regulatory Affairs Operations, Regulatory Affairs (Regional Center and Affiliates), departments within HQ (CMC, IT…), and the European Authorities.
Required Skills
  • Bachelor’s degree & English is required at a fluent level
  • Background in Regulatory Affairs Operations and/or Information Technology
  • Knowledge of the European Regulatory Affairs environment including marketing authorization types (CP, MRP/DCP, NP), and the main application types
  • Knowledge of the Pharmacovigilance regulation (Regulation EU 1235/2010) including IDMP, SPOR and/or XEVMPD
  • Knowledge of Regulatory Information Management Systems (RIM)
  • Knowledge of the structure of information on medicinal products and substances
  • Knowledge of the structure and contents of the Dossier (e.g. Module 3) is a plus
  • 5 years in business analysis and/or project management within large organizations
  • Experience with Software Development Life Cycle (SDLC) to implement GxP systems is a plus
  • Document and records management, content management
  • Knowledge of MS Office tools is a must, especially MS Excel
  • Experience with the technical aspects of using databases, logical data models, SQL… is a plus
  • Knowledge of Liquent Insight 6.x for Registrations is a plus
  • Knowledge of Document Management Systems (e.g. Documentum-based systems) is a plus
Interested? Send us your resumé
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