Non-Clinical Assessor - 75,585 - 84,840 p.a. + benefits

We are currently looking for a Non-Clinical Assessor to join our Licensing Strategy Team within the Health Quality and 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.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

Who are we?

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

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 Licensing Strategy function delivers guidance, policy and strategic initiatives to develop innovative pathways for medicines in the UK and position the UK as an attractive location for market authorisations. Through this function the Agency will be seen as a leader in facilitating early access to safe and innovative medicines, furthering the attractiveness of the life sciences sector and contributing to a positive patient experience and to the improvement of public health outcomes.

Whats the role?

The Non-clinical Assessor will assess the pre-clinical aspects of clinical trial and marketing authorisation applications for medicinal products and take decisions on their suitability for approval.

Key responsibilities:

• Carry out the assessment of data provided in clinical trial authorisation and marketing authorisation applications for chemical and biological products making appropriate recommendations and decisions in line with the protection of public health.
• Involvement in multiple Licensing pathways (ILAP, IRP, etc) and provision of scientific advice on the non-clinical aspects of drug development.
• Manage own workload working in conjunction with service coordinators and other assessors to meet agency deadlines
• Prepare and present objective assessments or other scientific papers to expert advisory bodies
• 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
• Contribute to assessment policy and practice and proactively identify where such contributions would be beneficial
• Contribute to divisional procedures and proactively identify where such contributions would be beneficial

Who are we looking for?

Our successful candidate will demonstrate the following:

• Delivering at Pace Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome
• Communicating & Influencing Excellent written and verbal communication skills
• Technical Working knowledge of relevant legislation and procedures applicable in the licensing of human medicinal products
• Managing a Quality Service Ability to handle high throughput of work and commensurate with experience and knowledge to meet required deadlines
• Experience Substantial experience in at least one of the following: toxicology or non-clinical regulatory affairs within the pharmaceutical industry, governmental departments or academia

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation

Behaviour Criteria:

• Delivering at Pace: Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome (I)
• Communicating and Influencing: Excellent written and verbal communication skills. (A,I)
• Managing a Quality Service: Ability to handle high throughput of work commensurate with experience and knowledge to meet required deadlines (A,I)

Experience Criteria:

• Substantial experience in at least one of the following; toxicology or non-clinical regulatory affairs within the pharmaceutical industry, governmental departments or academia. (A,I)

Technical Criteria:

• Up to date specialist level of knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products. (A,I)
• Working knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products. (A,I)

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

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