Medical Officer (Acting), National, HPAR / Oifigeach Leighis (Gníomhach), Náisiúnta, HPAR
This is a Temporary, Full Time vacancy that will close in {x} days at {xx:xx} BST.
The Vacancy
The Human Products Authorisation and Registration Department provides human medicines licensing services to the HPRA. The department is structured with two main technical sections - one delivering assessments for products authorised through the centralised mechanism and for clinical trials and the other delivering assessments for products authorised through mutual recognition, decentralised and national mechanisms - the National Licensing Section (NLS).
The Medical Officer (MO) will be expected to deliver clinical assessments which include an end-to-end benefit risk analysis across mutual recognition, decentralised and national applications, as well as variations to national product authorisations and national scientific advice. These assessments require an ability to make an informed decision from complex scientific data on the overall benefit risk analysis of a medicine. This will include mainly analysis of efficacy and safety data but can involve integration of pharmacology, quality and non-clinical data. The MO will be required to clearly communicate how this decision was made to a multidisciplinary team.
The MO will work closely with and maintain effective working relationships with other members of the NLS, as well as colleagues across the organisation, to ensure effective co-ordination and co-operation across all areas of assessment and to ensure that the objectives of the HPAR department are met.
This role is aligned to HPRA’s Capability Framework, which outlines the key experience, qualifications, behaviours required for success in this role.
Essential criteria:
- A 3rd level degree (NFQ level 8) in Medicine registerable with the Medical Council of Ireland.
- A minimum of 2 years of clinical experience (after becoming entitled to full registration).
- Professional membership examinations awarded in any speciality or discipline.
- Excellent critical appraisal and data analysis abilities in the areas of medical science.
- Experience in conducting literature reviews.
- Experience with risk benefit analysis, risk assessment, risk minimisation analysis.
- Demonstrated ability for technical scientific report writing, presentation and communication,
- Proficiency in the use of standard office software, such as Microsoft Office (Word, Excel, PowerPoint), cloud-based platforms (Microsoft Teams), and communication tools (Outlook, Teams)
Desirable criteria:
- An additional undergraduate or post graduate qualification (NFQ levels 9, 10) in a relevant scientific or related discipline.
- Experience with the evaluation of medicines in the pharmaceutical industry, regulatory, government authority, academic or clinical situation.
- Published clinical research in the academic or clinical area.
- Clinical pharmacology and drug development knowledge.
- Good understanding of methodology and biostatistics in pharmaceutical medicine
- Experience of representing an organisation at National and/or European level
- Awareness of relevant European and National legislation guidelines and reporting requirements specific to the EU Marketing authorisation process for range of applications
Closing date for applications: 22nd November 2026
Expected interview date: 4th December 2026
Preferred start date for this role: January 2027
The Company
We are the Health Products Regulatory Authority (HPRA) and we regulate medicines and devices for the benefit of people and animals. We are committed to excellence in health product regulation through science, collaboration and innovation.
Our remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.
The Benefits
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