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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.

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