Case Studies

CMC programme management

A client required urgent CMC team management following a departmental restructuring. An outsourcing company was brought in to reduce long term regulatory maintenance expenditure through a mixed offshore team with onshore management. The client had struggled to find a suitable CMC team leader at short notice. The role was initially planned for 3-6 months before a permanent member of staff could be located, but this turned into a 5 year long placement due to difficulties finding a suitable replacement individual with such a skill set.

 

The Stats

  • Team leader experience (years)
    • +20
  • Team size
    • 5 increasing to 25 over 5 years
  • Products managed
    • +20
  • Regions and geographies
    • Global
  • Additional value added
    • Department wide process improvement
    • Team training and personnel growth leading to succession
    • Decreased submission times
    • Increased quality metrics

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