Flexible Working
Learning & Development
Wellbeing

Medical Officer, Centralised and Clinical Trials Licensing - HPAR / Oifigeach Leighis - Ceadúnú Trialacha Láraithe agus Cliniciúla - HPAR

Salary €104,218-€116,263
Location Hybrid
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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 (EU) mechanism and for clinical trials and the other delivering assessments for products authorised through mutual recognition, decentralised and national mechanisms.

In terms of centralised assessments our strategy is to focus on the following therapeutic areas: respiratory, dermatology and ophthalmology and for clinical trials, there is a requirement for oncology expertise. We also have an ATMP and rare diseases portfolio.

The Medical Officer (MO) will be expected to deliver clinical assessments which include an end to end benefit risk analysis across both case types; centralised product and clinical trial assessments.

These assessments require an ability to make an informed decision from complex scientific data on the overall benefit risk analysis of a medicine and clinical trials. 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 and to present on behalf of the organisation to European committees and/or working groups.

The MO will work closely with and maintain effective working relationships with other members of the Centralised and Clinical Trial Licensing section, and 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.

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

Flexible
working

Learning & Development

Wellbeing

Employee Assistance Programme

Beneficial Leave Policies

Pension Scheme

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Published

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Closing

in X days

{Expiry}