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Job summary

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.

Job description

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).

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!

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

Benefits

Alongside your salary of £86,000, Medicines and Healthcare Products Regulatory Agency contributes £24,914 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• 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 Motoring , Boundless by CSMA
• Variety of staff and Civil Service clubs
• On-going learning and development

Things you need to know

Artificial intelligence

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 (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

We use the Civil Service Success Profiles to assess our candidates, find out more here.

• 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.

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.

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 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.

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.

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.

Feedback will only be provided if you attend an interview or assessment.This role has a minimum assignment duration of 3 years. An assignment duration is the period of time a Senior Civil Servant is expected to remain in the same post to enable them to deliver on the agreed key business outcomes. The assignment duration also supports your career through building your depth of expertise.

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.

Security

Successful candidates must undergo a criminal record check.People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

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).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see theCivil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : The Resourcing Team
• Email : Careers@mhra.gov.uk

Recruitment team

• Email : Careers@mhra.gov.uk

Further information

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 contact the Resourcing Team at Careers@mhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ