Location: Hybrid
This is a temporary, full-time vacancy that will close in 2 months at 23:59 BST.
The Vacancy
The Human Products Authorisation and Registration (HPAR) Department provides human medicines licensing services to the HPRA. The department is structured into 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.
Regarding centralised assessments, our strategy focuses on therapeutic areas such as respiratory, dermatology, and ophthalmology. For clinical trials, oncology expertise is required. The Senior Medical Officer (SMO) will serve as a therapeutic area lead, ensuring the department's strategy, operations, and capabilities align with current clinical and regulatory developments in their area of specialization.
Role Responsibilities
1. Lead the assessment of the clinical components of licensing applications for medicinal products submitted through the centralised authorisation procedure via the European Medicines Agency.
2. Contribute to the assessment of new clinical trial applications or other procedures as needed.
3. Make informed decisions from complex scientific data on the overall benefit-risk analysis of medicines and clinical trials, primarily analyzing efficacy and safety data.
4. Communicate clearly how decisions are made to a multidisciplinary team and represent the organisation to European committees and working groups.
5. Collaborate with team members across the organisation to ensure effective assessment coordination and meet departmental objectives.
The Company
We are the Health Products Regulatory Authority (HPRA), responsible for regulating 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 includes regulation of human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.
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