Non-Clinical Assessor (Biological) - 60,778 68,422 p.a. + benefits
- Civil Service
- Full Time
- Canary Wharf Estate
- 60,778
Job Description
Job summary
We are currently looking for a Non-Clinical Assessor (Biological) to join our Innovative MedicinesFunction within the Healthcare and Quality Access group.
This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.
The objective of the Healthcare Quality and Access portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.
The Innovative Medicines function delivers a risk appropriate critical appraisal of quality, safety and efficacy of innovative medicinal products, determining whether a products benefits outweighs the risks. It aims to accelerate their route to market to drive earlier patient access. Through this function the Agency will be seen as a leader in facilitating early access to safe and innovative medicines attracting the life sciences sector and contributing to a positive patient experience and to the improvement of public health outcomes.
Job description
Reporting to the Head of Biologicals team, a Non-clinical Assessor (Biologicals) evaluates the pre-clinical and environmental risk aspects of marketing authorisation, Early Access to Medicines (EAMs), Innovative Licensing and Access Pathway (ILAP) and clinical trial applications for medicinal products and make decisions on their suitability for approval.
This role encompasses the evaluation of a range of new biological medicinal products, including new active substances, advanced therapies, and other innovative products at different stages of development, as well as their environmental impact. The role also contributes to the development of regulatory policy, scientific guidance, and legislative frameworks relating to innovative medicinal products and emerging technologies. The reports written and recommendations made will be highly influential in initiating trials of new medicines and taking these through clinical development, and/or allowing new medicines to be made widely available to patients.
The post offers career development and progression opportunities in line with our internal development programme (scheme structure currently under review).
Key responsibilities
Service delivery
- Carry out the assessment of pre-clinical data provided in marketing authorisation and clinical trial authorisation applications for biological products, making appropriate recommendations and decisions in line with the protection of public health.
- Involvement in the ILAP and EAMs scheme, and provision of scientific advice on the non-clinical aspects and/or environmental aspects of drug development.
- Contribute to the drafting, review, implementation, and other cross-functional activities associated with development of legislation, scientific guidance, and policy documents relating to medicinal products and emerging technologies.
- Manage own workload, working in conjunction with other assessors to meet agency deadlines.
- Prepare and present objective assessments or other scientific papers to expert advisory bodies.
Service improvement
- Contribute to development of assessment policy, regulatory guidance, legislative implementation, and scientific practice; and proactively identify where such contributions would be beneficial.
- Contribute to divisional procedures and proactively identify where such contributions would be beneficial.
Quality and Assurance
- Promptly update agency, divisional or team work management databases to reflect the progress of owns work.
- Display a high level of attention to detail to ensure up to date, accurate data and documents are held on internal databases.
- Use own and agency resources in line with agency and divisional strategy to meet targets
- Support the generation and evaluation of evidence from internal and external sources to inform decision making, policy development, and continuous improvement.
Leadership and management
- Lead or contribute to multidisciplinary projects involving internal and external stakeholders to support regulatory, scientific and policy objectives.
- Develop to provide ad hoc advice to colleagues in the Division or Agency.
- Extend and deepen skills and knowledge in relevant scientific or professional areas.
General
- Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders, including government departments, healthcare organisations, academia, industry and patient representatives.
- Participate in other ad-hoc tasks/projects as requested by the Unit Manager.
The job description is not intended to be exhaustive and it is likely that responsibilities and outcomes may be altered from time to time in the light of changing circumstances and after consultation with the postholder.
Person specification
Essential Criteria:
- Previous experience in one or more of the following: pre-clinical aspects of drug development, translational science, medicines regulation or regulatory policy, ecotoxicology or environmental regulatory affairs, within the pharmaceutical industry, governmental departments or academia.
- Experience with data analysis particularly with Biological products, with gene therapy experience being an advantage.
- Experience contributing to the development, interpretation or implementation of regulatory policy, guidance or regulatory frameworks relevant to medicinal products.
- Experience working collaboratively with a broad range of stakeholders, including government bodies, healthcare organisations, academia, industry and patient groups.
