applicants
Application Handler-£34,841 p.a. + benefits
at Medicines and Healthcare products Regulatory Agency London in London (Published at 09-11-2023)
We are currently looking for an Application Handler to join our Clinical Investigations & Trials Team within the Scientific, Research & Innovation group.
This is a full-time opportunity, on a permanent. 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 Scientific Research and Innovation 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 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.
Clinical Investigations & Trials is focused on informing design and authorising clinical trials and clinical investigations whilst supporting and enabling clinical sponsors. This function will look to expand its activity across combination (medicines and devices) applications and will aim to ensure patient centricity is at the forefront.
What’s the role?
The successful candidate will act as the application handler for individual clinical investigation and clinical trial applications from manufacturers wishing to undertake clinical investigations and/or clinical trials in the UK with non-CE or non-UKCA marked Medical Devices.
Key responsibilities:
- Assists the Business Support Manager with workload management for the team. Has responsibility for monitoring assessment activities against targets within the Assessment team to identify peaks and troughs of workload on an individual and team basis.
- Provide clear, concise, and timely communications with applicants and expert assessors as required.
- Assists in generating monthly and ad hoc metrics and reports for Unit and Group reports as well as longer term reports on Unit performance. Generates metrics and reports as requested to respond to enquiries or questions, for example queries from ministers and FOI requests.
- Establishes close links to application processing colleagues and ensures application tracking spreadsheets and databases are maintained, that applications are processed through the case management systems and output letters are generated appropriately. Ensure clinical trial and clinical investigation applications have full end-to-end flow from applicant to assessor and back to the applicant with transparent tracking and communication.
- Provide support for strategy and policy within the Unit for both clinical trials and clinical investigations, particularly for application processing elements and technical aspects of applications and enquiry handling.
Who are we looking for?
Our successful candidate will:
- Excellent communicator; verbal, written and presentational.
- Confident and able to work in a pressurised, target driven environment, whilst maintaining high standards of quality and accuracy.
- Demonstrates strong planning and organisational skills with proven ability to effectively manage changing priorities.
- Excellent IT skills with proven ability to use and analyse data.
- Graduate with Life Science or other relevant degree, or appropriate work experience in the pharmaceutical, medical sector and/or regulatory sectors or equivalent experience.
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 candidates, find out more here.
- Online application form, including a statement of suitability, attached as a PDF demonstrating how you meet the person specification (Behaviours, Technical and Experience 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. 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
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: 09/11/2023
Interview date: W/C 27/11/2023
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
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