Senior Medical Assessor

We are currently looking for a Senior Medical Assessorto join our Clinical TrialsTeam within the Science Research & Innovation group.

This is a fulltime 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 Science Research and Innovation Group delivers public health impact worldleading research innovation and a unique regulatory proposition for patients and users via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 subGroups Innovation Accelerator Clinical Investigations and Trials Research and Development Standards Lifecycle Control Testing and Quality Assurance and Health & Safety.

Whats the role

Medical Assessors are responsible for the assessment of medical aspects of clinical trial authorisation (CTA) applications and amendments taking decisions on their suitability for approval and working mostly within a highly skilled multidisciplinary team.

The role encompasses a broad range of activities from assessing a CTA application for a new chemical or biological active substance to providing scientific advice to companies around medical and regulatory issues for the development of new drug products.

Key responsibilities:

• Riskbased 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. This will include consideration of the assessment from peers in other disciplines (including pharmaceutical quality and nonclinical) and will involve discussion with them on occasion. Prepare and present objective assessment reports and other scientific papers for example for expert advisory bodies.
• Provide scientific and clinical trial (CT) expertise in advice meetings with external stakeholders requesting crossagency or external support depending on the questions posed. Take a leading role in meetings including as meeting chair when required. Provide a written response to questions for specific meetings and also to other enquiries through a variety of sources including via internal customerfacing portals and the wider civil service.
• Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders. This includes with senior managers and senior colleagues across the civil service as well as across the research community and in a global forum. Manage any roles that matrix work into CT medical assessor working such as leading the team when required mentoring and playing active role in the training activities and development of new or nonaccredited assessors.
• Provide input to wider regulatory work that is relevant to CT and where CTspecific expertise is required including UK and global projects. This includes contributing to assessment policy and practice and proactively identifying where such contributions would be beneficial. Take a leading role in projects where a clinical lead is appropriate and provide input to key decisionmaking situations. Ability to support work across other units and groups in the Agency providing CT expertise when required for example to support Good Clinical Practice (GCP) aspects of trial conduct.

Who are we looking for

Oursuccessful candidatewill have:

• A degree in Medicine registered with the General Medical Council with a relevant postgraduate qualification and/or experience
• Previous experience of the assessment of clinical aspects of a clinical trial authorisation or marketing authorisation application
• Experience in the assessment of the design conduct and analysis of clinical trials and/or experience in the preparation of study reports or reviews of clinical data for publication or regulatory submission
• Ability to handle through output of work commensurate with experience and knowledge to meet required deadlines while maintaining adherence to legal and regulatory requirements

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

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The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

• Online application form including a CVand statement of suitability attached as a PDF demonstrating how you meet the person specification.Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank.Please ensure not to include any personal identifying information on your supporting information.
• Interview which can include questions based on theBehaviour Experience Technical and Strengths Success Profiles.

Additional Information for Internal Applicants

Eligible applicants should discuss their intention/application and supporting statement with their line manager. Following the discussion the line manager and countersigning manager must complete theManagers Endorsement Form(Word)which isthen submitted by the internal applicant on as an attachment document.It is recommended that you allow your line manager at leastthree working days to complete this to ensure your application can be submitted on time.

To apply please submit an application via the Oracle Recruit system and attach the following documents:

• CV
• Supporting statement detailing how you meet the criteria marked with an A on the person specification
• Managers endorsement form

Use of AI in Job Applications

Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others or generated by artificial intelligence as your own.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:22 May 2025

Shortlisting date: by 5 June 2025

Interview date:by 20 June 2025

Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.

If you need assistance applying for this role or have any other questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

Successful candidates must pass a disclosure and barring security check as well as animal rights and prolife activism checks. People working with government assets must completebasic personnel security standard checks.

Applicants who are successful at interview will be as part of preemployment 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 applicants 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 TaxFree Childcare. Determine your eligibilityhere.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit 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 Oyelami Head of Talent Acquisition .

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ