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)