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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.

Product Development Engineer Medical Affairs Regulatory Affairs Senior Operations Engineer Technical Support Engineering Technical Support Specialist Roscommon QA Specialist Quality Assurance Offaly QA Engineer Regulatory Affairs Manager Kildare Senior Research and Development Scientist Dublin South Contract Galway Senior Medical Scientist Engineering Principal Research Scientist Dublin North Validation Engineer Contract Academic Connected Health Validation Manager Validation Specialist Academic Research and Development Scientist Senior Research and Development Engineer QA Supervisor Louth Galway City Quality Manager Scientific Dublin Project Development Engineer Mechanical Engineer Biopharmaceutical QA RA Engineer Principal Engineer Research Fellow Dublin Greater Dublin West Biomedical Engineer Senior Manufacturing Engineer Healthcare Cork Midlands Snr R and D Engineer Westmeath Senior Project Engineer Research and Development BD Manager Life Science Quality Specialist Quality Systems Engineer Life Science Chemistry QA Validation Specialist Clinical Research Dublin City Centre Product Specialist Senior Project Manager Senior Scientist Quality Auditor Meath QA Executive Biotechnology North Leinster NPD Technologist Validation Scientist Quality Systems Specialist Clare Project Engineer Pharmaceutical Supplier Quality Engineer Research and Development Engineer Product Development Technologist Quality Assurance Technologist PhD Medical Device EHS Engineer Longford Quality Systems Lead R and D Manager Research Engineer Senior Quality Engineer Quality Control Supervisor QA Manager Project Lead Product Manager Leinster QE Manufacturing Engineer Quality Engineer Quality Control Manager Project Manager