Non-clinical Assessor - £60,778 p.a. + benefits

LondonJob SummaryWe are currently looking for a Non-clinical Assessor to join our Clinical Investigations and Trials Function within the Science Research and Innovation 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. Please be aware that this role can only be worked in the UK and not overseas.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.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 Innovation and Compliance Group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 3 sub-Groups, Innovation Accelerator and Regulatory Science, Clinical Investigations and Trials and Standards and Compliance.Job DescriptionThe clinical investigations and trials function ensure the efficient, pragmatic, proportionate and patient-centred advice for, and assessment of, clinical investigations into the performance and safety of medical devices and diagnostics as well clinical trials of investigational medicinal products.Non-clinical Assessors assess the pre-clinical aspects of clinical trial applications for medicinal products and take decisions on their suitability for approval.The role encompasses a broad range of activities from assessing an application for a new chemical or biological active substance, to providing scientific advice to companies around non-clinical / regulatory issues for development of new drug products.A comprehensive training programme is in place to support and further develop candidates with previous assessment experience.Key Responsibilities:Working independently, carry out the risk-based assessment of data provided in clinical trial authorisation initial and amendment applications for chemical, biological or advanced therapy products making appropriate recommendations and decisions in line with the protection of public health. Prepare and present objective assessment reports or other scientific papers to expert advisory bodies.Manage own workload working in conjunction with the support team and other assessors to meet agency deadlines.Promptly update agency-, group- and unit-level management databases to reflect the progress of own 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 group strategy to meet targets.Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders. Participate in other ad-hoc tasks/projects as requested by managers.The clinical investigations and trials function ensure the efficient, pragmatic, proportionate and patient-centred advice for, and assessment of, clinical investigations into the performance and safety of medical devices and diagnostics as well clinical trials of investigational medicinal products.Non-clinical Assessors assess the pre-clinical aspects of clinical trial applications for medicinal products and take decisions on their suitability for approval.The role encompasses a broad range of activities from assessing an application for a new chemical or biological active substance, to providing scientific advice to companies around non-clinical / regulatory issues for development of new drug products.A comprehensive training programme is in place to support and further develop candidates with previous assessment experience.Key Responsibilities:Working independently, carry out the risk-based assessment of data provided in clinical trial authorisation initial and amendment applications for chemical, biological or advanced therapy products making appropriate recommendations and decisions in line with the protection of public health. Prepare and present objective assessment reports or other scientific papers to expert advisory bodies.Manage own workload working in conjunction with the support team and other assessors to meet agency deadlines.Promptly update agency-, group- and unit-level management databases to reflect the progress of own 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 group strategy to meet targets.Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders. Participate in other ad-hoc tasks/projects as requested by managers.Person specificationOur successful candidate will demonstrate the following. Managing a Quality Service: Ability to handle throughput of work commensurate with experience and knowledge to meet required deadlines while maintaining adherence to legal and regulatory requirements. Delivering at Pace: Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome. Evidence of effective decision making, including clear communication of the purpose and reasons for recommendations and decisions internally and to external experts. Previous experience in at least one of the following, regulatory affairs, toxicology, or pharmacology within academia, governmental departments or the pharmaceutical industry. Degree in toxicology or other appropriate life science with relevant postgraduate experience or PhD.Person Specification: Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria:Communicating and Influencing (A, I)Managing a Quality Service (A, I) Delivering at Pace (A, I)Experience Criteria: Evidence of effective decision making, including clear communication of the purpose and reasons for recommendations and decisions internally and to external experts. (A, I) Previous experience in at least one of the following, regulatory affairs, toxicology, or pharmacology within academia, governmental departments or the pharmaceutical industry. (A, I)Technical Criteria:Degree in toxicology or other appropriate life science with relevant postgraduate experience or PhD (or equivalent). (A)Up to date specialist level of knowledge in one or more relevant scientific area or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products. Knowledge of relevant legislation and procedures applicable to the regulation of clinical trials. (A, I)Strengths Criteria Relationship Builder (I) Team Player (I)If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.ukAlongside your salary of £60,778, Medicines and Healthcare Products Regulatory Agency contributes £17,607 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays Privilege Leave: 1 day Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil ServiceCivil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666 Flexible working to ensure staff maintain a healthy work-life balance Interest free season ticket loan or bike loan Employee Assistance Services and access to the Civil Service Benevolent Fund Eligibility to join the Civil Service Motoring Association (CSMA)Variety of staff and Civil Service clubs On-going learning and development Selection process detailsWe use the Civil Service Success Profiles to assess our candidates, find out more here.Online application form, an application question of no more than 750 words demonstrating how you meet the person specification and key responsibilities as outlined in the advert. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. All information that you provide will be anonymised and our Hiring Managers will not be able to access your details when reviewing your application. Please ensure not to include any personal identifying information on your supporting information Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of candidates demonstrating up to date specialist level of knowledge in one or more relevant scientific area or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products. Knowledge of relevant legislation and procedures applicable to the regulation of clinical trials.Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.Closing date: 7th December 2025Shortlisting date: from 8th December 2025Interview date: from 5th January 2026If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.ukCandidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.Certain Roles Within The MHRA Will Require Post Holders To Have Vaccinations, And In Some Circumstances, Routine Health Surveillance. These Roles Include:Laboratory-based roles working directly with known pathogens Maintenance roles, particularly those required to work in laboratory settings Roles that involve visiting other establishments where vaccination is required Roles required to travel overseas where specific vaccination may be required. Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Florentina Oleylami, Head of Talent Acquisition, Florentina.Oyelami@mhra.gov.uk.If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.ukinfo@csc.gov.ukCivil Service CommissionRoom G/81 Horse Guards RoadLondonSW1A 2HQFeedback will only be provided if you attend an interview or assessment.SecuritySuccessful candidates must undergo a criminal record check.People working with government assets must complete baseline personnel security standard (opens in new window) checks.Successful candidates must undergo a criminal record check.People working with government assets must complete baseline personnel security standard (opens in new window) checks.Nationality requirementsThis Job Is Broadly Open To The Following Groups:UK nationalsnationals of the Republic of Irelandnationals of Commonwealth countries who have the right to work in the UKnationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil ServiceFurther information on nationality requirements (opens in a new window)Working for the Civil ServiceThe Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.Diversity and InclusionThe Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.Contact point for applicantsJob Contact :Name : Roshni DesaiEmail : roshni.desai@mhra.gov.ukRecruitment teamEmail : Careers@mhra.gov.ukFurther informationIn accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should contact the Resourcing Team at Careers@mhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ