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