Senior Assessor, Biological, Centralised and Clinical Trials Licensing - Human Products Authorisation & Registration / Measúnóir Sinsearach, Bitheolaíoch, Ceadúnú Trialacha Láraithe agus Cliniciúla
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 Centralised and Clinical Trial Licensing Section undertakes assessments for products authorised via the EU centralised procedure and for products used in clinical trials while the National Licensing Section conducts assessments for products authorised through mutual recognition, decentralised, and national procedures.
The position of Senior Assessor, Biological will be the team lead & line manager of the biological team in the Centralised and Clinical Trials licensing section, therefore people management experience is essential for the role. The Centralised and Clinical Trials licensing section consists of many scientific disciplines including biological, chemical, clinical, methodology and non-clinical disciplines. The Biological team delivers assessments for products authorised through the centralised (EU) mechanism, and clinical trials. The team also deliver biological related work through the national licensing section including projects & emerging national legislation and policy changes.
As the biological aspects of regulatory medicine is a rapidly evolving field, the Senior Assessor is expected to lead the team through emerging developments, technologies, legislations and support colleagues through ongoing knowledge sharing and dynamic upskilling.
The Senior Assessor, Biological will support the HPRA’s and Centralised and Clinical Trials Section’s overall centralised & clinical trial assessment strategy in terms of training, capability development and meeting the business needs.
At organisational level, the Senior Assessor, Biological will ensure the successful execution of strategies and contribute to long-term organisational sustainability and success. The Senior Assessor, Biological will be expected to display competencies at a strategic proficiency level relating to leadership, knowledge sharing, learning & growth, strategic thinking & impact and organisational awareness.
The Senior Assessor, Biological will work closely with and maintain effective working relationships with other members of the HPAR 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.
QUALIFICATIONS AND EXPERIENCE
- To be considered for this post, candidates must have:
- A 3rd level degree (NFQ level 7 or 8) in a scientific discipline that is relevant to the pharmaceutical/quality assessment of biological products.
- Post graduate qualification (NFQ levels 9 or 10) in a relevant scientific or related discipline.
- A minimum of 5 years relevant experience in research, healthcare, industry or regulatory environment or other relevant public health body.
- A minimum of three years' experience people management.
- Experience in managing employee performance, providing feedback, and fostering a collaborative team environment.
- Relevant experience in technical writing, or assessment of, module 3 for new product applications and the investigational medicinal product dossier for products of biological origin.
- Relevant experience with module 3 for advanced therapies or biosimilar medicines.
- Detailed knowledge and experience of EU and national legislation and guidelines relating to the regulatory requirements for medicines.
- Ability to employ analytical thinking on complex data and make appropriate recommendations under pressure.
- Excellent leadership skills with a demonstrated ability to manage a team where high outputs and high-quality work are achieved.
- An ability to adapt to changing conditions and display ability to generate effective and pragmatic solutions to new situations and problems, both strategic and operational.
- Be a self-starter, capable of excellent communication, negotiation and decision making.
- 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 following would be considered an advantage:
- Experience with scientific advice applications for biological medicines submitted through the EU system.
- Experience of working collaboratively with cross-organizational teams in a solution focused manner.
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
Documents
Alternatively, please sign in with...
Published
Not PublishedClosing
in X days