ISO IDMP Process Consultant 2188 views

Assignment description

We are now looking for 1-3 ISO IDMP Process Consultants for our client in the Pharma Industry.

 

Job description:

See attached file for further details.

The project:

Team of 1-3 people to support the development of a ‘process blueprint’, outlining the master data pieces associated with the R&D compound, trials and regulatory submissions on products, including roles & responsibilities for the generation of master data pieces (e.g. a long trail from research project number, compound name, trial information and their dependencies/traceability).

This is supporting the data requests from ISO IDMP.

Project phases towards the blueprint are:

  • Draft the current understanding of the master data pieces based on stakeholder dialogue with app. 40 stakeholders from R&D, Product Supply and Regulatory (stakeholder interview done by Data Office, follow-up meetings are in the pipeline)
  • Prepare a workshop (preferably to be held late Summer) with all relevant stakeholders to validate the draft piece and create the final blueprint, also outlining supporting/enabling processes/data needs
  • Facilitate the workshop with app. 30-40 people involved and document workshop output – expecting to have a solid process blueprint ready following the workshop
  • Finalize the process blueprint and hand-over for technology solution scoping purposes
Required skills
  • Workshop Facilitation
  • Master Data
  • Process blueprints
  • ISO IDMP
Languages
  • English (Proficient)
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