Scientific Officer, Centralised and Clinical Trial Licensing - HPAR / Oifigeach Eolaíochta - Ceadúnú Trialacha Láraithe agus Cliniciúla - 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 (EU) mechanism and for clinical trials and the other delivering assessments for products authorised through mutual recognition, decentralised and national mechanisms.
The Scientific Officer (SO) role will support the evaluation and regulation of the safety and efficacy of medicinal products (drugs) in Ireland and the European Union and provide technical support to the centralised and clinical trial licensing section and the Human Products Authorisation and Registration (HPAR) department.
The Scientific Officer will report to the Clinical Trials Portfolio Lead and work closely and maintain effective working relationships with the Centralised and Clinical Trial Licensing section and with members of the HPAR Department as a whole, to ensure effective co-ordination and co-operation across all areas of assessment.
Specifically, the SO role will include ‘project management’ of clinical trials and their associated activities, contribute to the work of the Clinical Trial Portfolio Team and relevant sub-process owners in process review and optimisation, technical validation of clinical trial applications and technical review of clinical trial safety data. The Scientific Officer will be a key member of the Clinical Trial Portfolio Team and will assist in delivering the Clinical Trial Portfolio’s objectives. The Scientific Officer will also provide support to the clinical trial assessment teams and provide cross cover for other Scientific Officers in the Centralised and Clinical Trial Licensing section.
The SO role focuses on delivering the core responsibilities of the role and team by producing high-quality work on time, following processes, and achieving results that matter. The SO will be expected to display competencies at the appropriate delivery level relating to leadership, knowledge sharing, learning & growth, strategic thinking & impact and organisational awareness.
Qualifications and Experience
- To be considered for this post, candidates must have:
- Qualified as a pharmacist
- A minimum of one years’ relevant experience in an academic, healthcare, industry or regulatory environment relating to medicinal products
- Strong interest in developing knowledge and understanding of the operation of the European Medicines Regulatory Network
- Relevant experience in the collation, evaluation and presentation of scientific data
- Demonstrated initiative and team working capabilities
- Excellent interpersonal, communication and presentation skills
- Excellent administrative and organisational skills, including the ability to work under pressure to tight deadlines
- Proven ability to work unsupervised
- Excellent attention to detail
- Proficient in the use of standard office software, such as Microsoft Office (Word, Excel, PowerPoint), cloud-based platforms (Microsoft Teams), and communication tools (Outlook, Teams)
- In addition, the ideal candidate will also have:
- Post graduate qualification (NFQ levels 9 or 10) in a relevant scientific or related discipline
- Project Management qualification or trained in Lean Six Sigma
- Clinical Pharmacy / Clinical Trial Experience
- Awareness of relevant European and National legislation relating to the regulation of medicinal products and in particular clinical trials.
- Relevant experience of managing scientific projects
- Direct experience working with stakeholders/customers
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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