Flexible Working
Learning & Development
Wellbeing

Senior Medical Officer - National Licensing, Human Products Authorisation and Registration / Oifigeach Eolaíochta - Ceadúnú Náisiúnta, Táirgí don Duine a Údarú agus a Chlárú

Salary €117,275 - €130,829
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 (HPAR) Department is responsible for delivering human medicines licensing services on behalf of the HPRA. The department comprises two principal technical sections. The National Licensing Section conducts assessments for products authorised through mutual recognition, decentralised, and national procedures, while the Centralised and Clinical Trial Licensing Section undertakes assessments for products authorised via the EU centralised procedure and for products used in clinical trials.

In addition to assessment, The National Licensing Section also plays a strategic role in many national regulatory aspects involving human medicines. It also collaborates across the HPRA in supporting improved product access for Irish patients and provides national scientific advice to stakeholders. As such, the Senior Medical Officer (SMO) will be a HPRA representative across a range of national committees and collaborate with other national bodies on various working groups as the need arises.

The SMO will develop and shape organisational frameworks that align with strategic priorities and improve overall efficiency. The SMO will be involved in shaping emerging legislation and policy, strengthening systems to proactively manage and reinforce health product availability and ensure preparedness for public health threats, using a One Health approach. The SMO will also be required to lead on HPRA licensing projects of national significance, which could include provision of briefings to the Department of Health, Oireachtas Committees and other national stakeholders.  

The SMO, reporting to the National Licensing Manager, will sit on the National Licensing Leadership Team (NLLT). At organisational level, they will ensure the successful execution of strategies and contribute to long-term organisational sustainability and success. The SMO will be expected to display competencies at a strategic level relating to leadership, knowledge sharing, learning & growth, strategic thinking & impact and organisational awareness.

The SMO will work closely with and maintain effective working relationships with other members of the HPAR department, the Compliance department 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

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