References

Definition of the new organization of the "Global Regulatory Affairs Operations" department

PROJECT OUTLINE

  • Methodological support to all the managers of the “Global Regulatory Affairs Operations” department, allowing to define the transformation plan.
  • Definition of the global roadmap of the department and the roadmaps per team.

PROJECT APPROACH

  • Organization and facilitation of workshops to identify and prioritize department initiatives.
  • Coordination of action plans for each identified initiative: individual interviews and workshops to define the scope, the RACI, the three-year roadmaps for each activity of the department.
  • Organization of a seminar to share these roadmaps with the teams.
  • Evaluation of the evolution of the department’s maturity.
  • Additional methodological support for specific topics per team:
    • “Clinical Data Transparency” and “Registries Operations”: definition of the governance of the “Data Transparency” topic and review of the activities of the PMO in charge of the GDPR topic.
    • Compliance: structuring of team operations (meeting structure, team documentation architecture, monitoring tools, etc.).
    • Publishing: analysis of the team reorganization options.

RESULTS

  • Three-year roadmaps for the department and each team.
  • Perimeters and RACI of each activity.
  • Assessment of the evolution of the department’s maturity.
  • Definition of the governance of the “Data Transparency” topic.
  • Package for the functioning of the “Compliance” team: structure of the meetings, architecture of the team documentation, follow-up tools, etc.
  • Definition of the new organization of the “Publishing” department.

Pagamon is a strategy and transformation consulting firm founded in 2013. We support major players in the industry, services and life sciences sectors in their search for balance. Helping them structure their strategic vision, transform their operational and/or digital model, and drive change. To support profitable, sustainable and responsible growth. As a committed player, Pagamon leads the Observatory of the Balanced Organization™, articulated around a "think tank" and an annual survey. In order to provide an innovative, sometimes offbeat, perspective on the strategic and operational implementation of transformations to support the growth of companies.