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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.

Research and Development Scientist Dublin Greater Technical Project Manager Pharmaceutical Quality Assurance Controls Engineer Business Development Executive Academic Research Scientist Senior Research and Development Scientist QA Specialist Manufacturing Executive Louth Software Engineer Republic of Ireland QA RA Engineer Quality Engineer Sligo Biotechnician Senior Automation Engineer Quality Control Supervisor Principal Engineer QA Engineer Dublin Life Science Clinical Research Contract Connected Health Kilkenny Project Lead Process Engineer Supply Chain Biomedical Scientist Galway Process Technician Product Manager Snr Validation Engineer Longford Research and Development Technician Leinster Design Engineer Academic Validation Specialist Biopharmaceutical Galway City Senior Manufacturing Engineer Validation Engineer Clinical Research Associate Validation Scientist R and D Biochemist Quality Systems Lead Supply Chain Project Development Engineer Offaly Research Assistant Scientific Limerick Regulatory Affairs Programmer BD Manager Senior Project Engineer Cavan Biotechnology Life Science Applications Engineer Maintenance Technician Microbiology Operational Excellence Lead Leitrim Regulatory Affairs Executive Roscommon QA Validation Specialist Dublin North Production Engineer Lead Quality Engineer Clare EHS Engineer Biotechnologist New Product Development Engineer Donegal Westmeath Engineering Manager QA Supervisor Graduate Contract Quality Systems Specialist Technical Support Specialist R & D Technician Manufacturing Engineer Hardware Implementation Engineer IT Solutions Software Developer Project Manager Upstream Process Medical Affairs Automation Engineer Senior Regulatory Affairs Officer Senior Research and Development Engineer Engineering Quality Systems Administator Meath Regulatory Affairs Consultant Regulatory Affairs Clinical Research Bioprocess Engineer Electronic Engineer Process Development Engineer Chemistry Regulatory Affairs Manager QE Manufacturing Engineer Product Development Engineer Principal Research Scientist Dublin City Centre Senior Operations Engineer Electrical Engineer Healthcare Dublin South Senior Project Manager R and D Manager Mechanical Engineer Technical Specialist QA Executive Cork Manufacturing and Technology Manager Supplier Quality Engineer Quality Specialist Regulatory Affairs Director Clinical Project Manager Quality Assurance Technologist Mayo Biotechnology Specialist QA Manager Consultant (Medical) Regulatory Affairs Officer Medical Device Principal Scientist Midlands Product Specialist Product Development Technologist Technical Support Senior Test Engineer Validation Manager Research and Development Quality Control Manager Limerick City Project Engineer NPD Technologist Research and Development Engineer Junior Product Specialist C++ Software Engineer Regulatory Affairs Senior Quality Engineer Biomedical Engineer Athlone Maintenance Engineer Manufacturing Coordinator R and D Director Equipment Engineer North Leinster Kildare Quality Systems Engineer Design Assurance Regulatory Affairs Specialist Connaught Research Engineer Research Fellow Laois Engineering Snr R and D Engineer Dublin West Quality Manager