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Organisational Structure

The following is breakdown of the functions and organisation of the Medical Affairs department within a typical pharmaceutical company. The Medical Affairs department acts on the whole in tandem, with all departments interrelated and working together.

Typically the medical affairs department is headed up by the Medical Director. They are responsible for the following departments.

  • Pharmacovigilance- reporting of SAE's and other pharmacovigilance data of current drugs on the market and also preliminary data for drugs in development.

  • Clinical Research- management of ongoing phase II-IVb clinical trials.

  • Regulatory Affairs- management of the preparation and submission of regulatory documentation to the relevant government regulatory bodies - IMB, FDA etc. New licence applications and/or indication applications.

  • Medical Information- responsible for the dissemination of technical information regarding current products to primary / secondary care providers and academia. Responsible for the training of sales force with regards to technical information and also the dissemination of information internally.

  • Quality Assurance- responsible for the development and management of quality systems within the department - writing up SOP's and training other stakeholders in their implementation and application.

Quality Systems Specialist Engineering North Leinster Senior Research and Development Scientist QA Manager Equipment Engineer Manufacturing and Technology Manager Supply Chain Specialist Biotechnician Sligo Engineering Quality Systems Lead NPD Technologist Project Lead Maintenance Technician Quality Systems Administator Principal Research Scientist Dublin North Biotechnologist Offaly Life Science Quality Manager Dublin South Healthcare Technical Specialist Roscommon New Product Development Engineer Quality Assurance Quality Auditor Manufacturing Coordinator Validation Scientist Validation Specialist Supply Chain Coordinator Engineering Manager Limerick Quality Specialist Technical Support Specialist Research and Development Scientist QA Engineer Regulatory Affairs Validation Coordinator Electrical Engineer Project Manager Dublin Design Engineer Research and Development Engineer Manufacturing Engineer Design Assurance R & D Technician Research Engineer Supply Chain Manager R and D Director Clinical Project Manager Electronic Engineer Process Engineer Academic IT Professional Pharmaceutical Research Fellow Automation Software Controls Manager Applications Engineer Senior Research and Development Engineer QE Manufacturing Engineer Republic of Ireland Sales Engineer Quality Systems Engineer Kildare Louth Technical Project Manager Clare BD Manager Technical Support Research Scientist EHS Engineer Research and Development Manufacturing Executive Mechanical Engineer Validation Manager Project Development Engineer Process Technician Kilkenny Midlands Project Engineer Cork R and D Biochemist Medical Affairs Snr R and D Engineer Biotechnology Specialist Quality Assurance Technologist Senior Project Manager Mayo Senior Operations Engineer IT Solutions Quality Control Manager Galway City Scientific Product Manager Dublin Greater Senior Project Engineer Biomedical Scientist Product Development Engineer Principal Scientist Senior Test Engineer Connected Health QA Validation Specialist Limerick City Software Developer Hardware Implementation Engineer QA RA Engineer Life Science Production Engineer QA Supervisor Athlone Lead Quality Engineer Lean Team Leader Galway C++ Software Engineer Senior Manufacturing Engineer Systems Analyst R and D Manager Supplier Quality Engineer Quality Engineer Dublin West Regulatory Affairs Manager Process Development Engineer Cavan Medical Device Meath Senior Scientist Longford Laois Biotechnology Product Specialist Clinical Research Biomedical Engineer Postdoctoral Research Fellowship Java Developer QA Executive Software Engineer QA Specialist Quality Control Supervisor Academic Principal Engineer Snr Validation Engineer Senior Quality Engineer Research and Development Technician Biopharmaceutical Validation Engineer Leinster Product Development Technologist Dublin City Centre Programmer Junior Product Specialist