Medical Assessor (Clinical Trials) London, England
Job description
We are currently looking for an experienced Medical Assessor (Clinical Trials) to join our Clinical Investigations and Trials team 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. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 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 8 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 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.
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).
As part of accepting this role you have accepted an assignment duration of 3 years which sets out the minimum period that you are expected to remain in this post to deliver agreed key business outcomes and build capability in the role. Please note this is not a contractual provision and does not form part of your terms and conditions.
Who are we looking for?
Our successful candidate will:
The successful candidate will have the ability to communicate with others in a clear, honest and enthusiastic way in order to explain complex issues and to build trust. They must also have 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 and evidence of effective decision making, including clear communication of the purpose and reasons for recommendations and decisions internally and to external experts. You will also be medically qualified, registered with the GMC and with a relevant higher medical or scientific qualification and have 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!
The posts offer career development and progression opportunities in line with our internal development programme (scheme structure currently under review.)
At interview stage, if candidates do not score high enough to be appointed to this SCS1 role but have passed the minimal requirements, they could be offered a role at the lower grade of G6.
G6 – Medical Assessor - £67,158 p.a. + benefits – Job Description
SCS1 – Medical Assessor - £73,000 p.a. + benefits – Job Description
Closing date: 24th February 2023
Interview date: 6th March 2023
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The selection process:
We use the Civil Service Success Profiles to assess our candidates, find out more here.
- Online application form, including a statement of suitability, including examples attached as a PDF demonstrating how you meet the person specification criteria. 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.
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.
If you require any disability related adjustments at any point during the process, please contact [email protected] as soon as possible.
If you need assistance applying for this role or have any other questions, please contact [email protected]
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 [email protected].
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, [email protected].
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
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