Medicines and Healthcare products Regulatory Agency
Medical Assessor
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Accredited Medical Assessor
We are currently looking for an Accredited Medical Assessor to join our Clinical Investigations and Trials Function within the Scientific 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.
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. 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 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.
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.
What’s the role?
The 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.
The role is both intellectually challenging and rewarding and provides significant opportunity for scientific and regulatory learning.
Key responsibilities:
- 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.
- 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.
- Contribute where medical input is required in critical clinical trial projects and contribute to the Innovative Licensing and Access Pathway (ILAP).
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Who are we looking for?
Our successful candidate will have:
- Substantial proven experience working as a medical assessor in the assessment of Clinical Trial Authorisation (CTA) applications, making independent decisions on their suitability for approval within regulatory timelines, as well as experience providing scientific or regulatory advice. Demonstrating a consistently high level of performance in the role including a high throughput of work commensurate with experience and knowledge to meet required deadlines.
- 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.
- Up to date knowledge of relevant legislation and procedures applicable to the regulation of clinical trials.
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)
- Making Effective Decisions (A, I)
Experience Criteria:
- Substantial proven experience working as a medical assessor in the assessment of Clinical Trial Authorisation (CTA) applications, making independent decisions on their suitability for approval within regulatory timelines, as well as experience providing scientific or regulatory advice. Demonstrating a consistently high level of performance in the role including a high throughput of work commensurate with experience and knowledge to meet required deadlines (A, I)
Technical Criteria:
- Degree in Medicine, registered with the General Medical Council, with a relevant postgraduate qualification and/or experience (A)
- Previous experience of the assessment of clinical aspects of a clinical trial authorisation or marketing authorisation application (A)
- Up to date knowledge of relevant legislation and procedures applicable to the regulation of clinical trials (I)
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/static/files/KXxAQl3y1OTaz9re.pdf]!
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
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 a statement of suitability, of no more than 1,000 words 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. 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.
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In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of Substantial proven experience working as a medical assessor in the assessment of Clinical Trial Authorisation (CTA) applications, making independent decisions on their suitability for approval within regulatory timelines, as well as experience providing scientific or regulatory advice. Demonstrating a consistently high level of performance in the role including a high throughput of work commensurate with experience and knowledge to meet required deadlines.
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
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%3A%2F%2Fwww.civil-service-careers.gov.uk%2Fartificial-intelligence-and-recruitment%2F&data=05%7C02%7CUfuoma.Eriemo2%40mhra.gov.uk%7C3d175bf263f54c3cf85608de3bfa288f%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C639014142773052769%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=2VE8qZPdzo8azEL775DBoKUPz5zMHopZPjc9cs3KuOk%3D&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 as soon as possible.
Closing date:
10 August
Shortlisting date:
from 12 August
Interview date:
from 19 August
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 [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].
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
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