Senior Scientific Assessor at Medicines and Healthcare Regulatory Agency

, , United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

05 Oct, 26

Salary

0.0

Posted On

07 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medicines Labelling Regulation, Patient Information Review, Clinical Data Analysis, Regulatory Compliance, Stakeholder Management, Complaint Resolution, Pharmacology, Scientific Assessment, Public Health Protection, IT Proficiency

Industry

Government Administration

Description

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 Authorisation Lifecycle function is an enabler, central to delivery of the frontline HQA group. It includes data assurance and quality, high-volume certification work and coordination and support to the frontline functions. It also includes some more complex activity that supports across the product lifecycle such as medicines and medical devices, borderline, patient information and medicines advertising. What’s the role? The Product Information Quality Unit reviews applications for changes to product information and aims to act as a centre of excellence within the Agency to promote high quality patient information. Working with internal and external stakeholders managing queries and collaborating on special projects. Key responsibilities: * To assess labelling and patient information leaflet applications, with awareness of the needs of patients, carers and health care professionals and the current regulatory framework. * To complete strategic targeted reviews of patient information and suggest improvements to the pharmaceutical companies or, if necessary, take regulatory action. * Manage and resolve complaints on patient information material from health professionals, industry, colleagues and the public, with input from medical, scientific and other staff as required * To assist in implementing the Agency initiatives to review the labelling for products identified as possibly contributing to medication errors, in association with NHS Improvement. Who are we looking for? Our successful candidate will demonstrate the following: * Knowledge and/or experience of relevant regulations and procedures applicable to the regulation of medicines labelling and patient information. * The ability to critically analyse complex clinical/scientific information from a number of sources under pressure and make appropriate recommendations or decisions to protect public health. * Working Together * Delivering at Pace * A degree in pharmacology, pharmacy, biochemistry, physiology or other relevant scientific discipline Person Specification: Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria: * Working Together (A,I) * Delivering at Pace (A,I) * Communicating and Influencing (A,I) Experience Criteria: * Knowledge and/or experience of relevant regulations and procedures applicable to the regulation of medicines labelling and patient information. (A,I) * The ability to critically analyse complex clinical/scientific information from a number of sources under pressure and make appropriate recommendations or decisions to protect public health. (A,I) Technical Criteria: * A degree in pharmacology, pharmacy, biochemistry, physiology or other relevant scientific discipline. (A) * IT skills appropriate for an information-based organisation and a fast-paced working environment. (A) If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! [https://mhra-gov.filecamp.com/s/d/7FssUR8xD9ctxY21] 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.uk [careers@mhra.gov.uk] The selection process: We use the Civil Service Success Profiles to assess our candidates, find out more here [https://www.gov.uk/government/publications/success-profiles]. * Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application. * 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: Knowledge and/or experience of relevant regulations and procedures applicable to the regulation of medicines labelling and patient information 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. Use of AI in Job Applications Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance [https://eur01.safelinks.protection.outlook.com/?url=https://www.civil-service-careers.gov.uk/artificial-intelligence-and-recruitment/&data=05|02|Ufuoma.Eriemo2@mhra.gov.uk|3d175bf263f54c3cf85608de3bfa288f|e527ea5c62584cd2a27f8bd237ec4c26|0|0|639014142773052769|Unknown|TWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ==|0|||&sdata=2VE8qZPdzo8azEL775DBoKUPz5zMHopZPjc9cs3KuOk=&reserved=0]for more information on appropriate and inappropriate use. If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk [careers@mhra.gov.uk] as soon as possible. Closing date: 16th July 2026 Shortlisting date: from 17th July 2026 Interview date: from 2nd August 2026 If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk [careers@mhra.gov.uk] Candidates 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 [https://www.gov.uk/government/publications/nationality-rules]. 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 [https://www.gov.uk/government/publications/government-baseline-personnel-security-standard?_ga=2.149328757.2118900794.1613132232-433185063.1580991281]. 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 [https://www.childcarechoices.gov.uk/]. Individuals appointed on level transfer will retain their existing salary and are responsible for ensuring they fully understand the financial implications of any potential move and the impact (if any) on their terms. If an individual is in any doubt, they should seek clarification before accepting a job offer. Staff joining on promotion will receive up to a 10% increase of their current basic salary, or the pay band minimum, whichever is the greater. The individual will not retain any allowances paid by the former department/Agency, unless there are special circumstances, such as a reserved right to those allowances on transfer. 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 [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 careers@mhra.gov.uk If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk [https://civilservicecommission.independent.gov.uk/] info@csc.gov.uk [info@csc.gov.uk] Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ About Us 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 agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad. The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.

Responsibilities

The role involves assessing labelling and patient information leaflet applications to ensure high quality and regulatory compliance. It also includes managing complaints regarding patient information and conducting strategic reviews to prevent medication errors.