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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.

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