Medical Assessor - £76,000 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency
Apply before 11:55 pm on Friday 18th October 2024
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About the job
Job summary
We are currently looking for a Medical Assessor to join our Clinical Investigations & Trials function within the Science, Research & 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 Science, Research and Innovation Group delivers public health impact, world-leading research innovation, and a unique regulatory proposition for patients and users via an ambitious Science Strategy which will balance innovation against sustainability and affordability.
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.
Job description
What’s the role?
This role encompasses a broad range of activities from assessing clinical aspects of clinical trial authorisation (CTA) applications and amendments to existing CTAs, to providing scientific advice to companies around clinical/regulatory issues for the development of new products.
The role holder will be expected to contribute to policy and strategy development to maintain and enhance the reputation of the UK as a great place to conduct clinical research, identifying synergies and opportunities for streamlining across the functional areas of the Science, Research and Innovation Group.
This role is both intellectually challenging and rewarding and provides significant opportunity for scientific and regulatory learning.
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 and other scientific papers, for example for expert advisory bodies.
- Manage own workload working in conjunction with the support team and other assessors to meet agency deadlines.
- Provide scientific and clinical trial expertise in advice meetings with external stakeholders, obtaining cross-agency or external support depending on the questions posed. Provide a written response to enquiries submitted through a variety of sources, including via internal customer-facing portals and the wider civil service.
- 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.
Person specification
The successful candidate will be able to communicate with others clearly, honestly, and enthusiastically to explain complex issues and build trust.
Our successful candidate will be able to demonstrate that they meet the following criteria:
- Medically qualified, registered with the GMC and with a relevant higher medical or scientific qualification.
- Delivering at Pace: Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Experience of the design, conduct and analysis of clinical trials and/or experience in the preparation of study reports or reviews for publication or regulatory submission.
- Evidence of effective decision making, including clear communication of the purpose and reasons for recommendations and decisions internally and to external experts.
- Up to date knowledge of relevant legislation and procedures applicable to the regulation of clinical trials.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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Benefits
- 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 Service
- Civil 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
Things you need to know
Selection process details
We use the Civil Service Success Profiles to assess our candidates, find out more here.
- Online application form, including application questions demonstrating how you meet the Behaviour, Experience and Technical person specification. 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. 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.
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 statement of suitability provided. You can view the criteria for this role in the job description.
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 careers@mhra.gov.uk as soon as possible.
Closing date: 18 October
Shortlisting date: 21 October
Interview date: 29 October
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 questions, please contact 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.
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.
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 Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@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
Civil Service Commission
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Feedback will only be provided if you attend an interview or assessment.
As part of accepting this role you will be agreeing to the expected assignment duration set out above. This will not result in a contractual change to your terms and conditions. Please note this is an expectation only, it is not something which is written into your terms and conditions or indeed which the employing organisation or you are bound by. It will depend on your personal circumstances at a particular time and business needs, for example, would not preclude any absence like family friendly leave. It is nonetheless an important expectation, which is why we ask you to confirm you agree to the assignment duration set out above.
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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).
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Contact point for applicants
Job contact :
- Name : The Recruitment Team
- Email : careers@mhra.gov.uk
Recruitment team
- Email : careers@mhra.gov.uk
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