Support in Business/Technical Analysis Reference number: 2136

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 syst
• 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 rela

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