Leadership of cross functional project & product development teams.  General Management.  Project execution, resources and budget management.  Temporary/maternity leave assignments.  Change management. Organisational design consultancy. Regulatory Affairs strategy.

Program Management, Project Management, Clinical trial monitoring, Protocol and CRF design, Sponsored study and investigator initiated study support.  Phase 1 Expertise.  IND aligned study design and execution.  Subject Recruitment Strategy.  Study steering committee management.  Investigator meeting support.  Clinical trial audit support.  Investigational product manufacture and management.

Medical writing (protocol, study report, manuscript etc).  Pharmacovigilance.  Product recall management.  Promotional material review and support.   Management of independent data monitoring / safety review committees / scientific advisory boards.

Process and quality system review, audit preparation and management, cGMP & ISO 9001 consultancy.