Application Handler

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., This is a support role that specialises in the handling of applications to the Unit for Clinical Investigations and Trials. Reporting to the Business Manager, the Application Handler acts as the dedicated point of contact for all technical and complex procedural queries referred from the other units and Groups across the Agency. The role is also responsible for overseeing allocation of applications and assisting with workload management, specifically with the monitoring of assessment targets and work queue management in the case management systems and maintaining good working relations with other Agency application processing staff., * Process Clinical Trial and Clinical Investigation applications via appropriate case management systems and ensure allocation to appropriate assessors and reviewers.

• Assists the Business 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, including the arranging and facilitation of external facing advice meetings between the internal and external stakeholders.
• 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.
• Assists with IT development projects and piloting new processes related to Clinical Trials and Clinical Investigations, as required.
• 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 Clinical Investigations and Trials, particularly for application processing elements, technical aspects of applications, enquiry handling and advice meetings., * Online application form, including a statement of suitability, of no more than 750 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., 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.

Do you have experience in Presentation skills?, * Making Effective Decisions (A, I)

• Managing a Quality Service (A)
• Delivering at Pace (A, I)
• Communicating and Influencing (A, I)

Experience Criteria:

• Proven experience of working in and managing a busy team demonstrating effective management, organisation and delegation skills (A, I)
• Experience of working in the pharmaceutical, medical sector and/or regulatory sectors desirable (A)

Technical Criteria:

• Graduate with Life Science or other relevant degree, or appropriate work experience in the pharmaceutical, medical sector and/or regulatory sectors or equivalent experience (A)
• Excellent IT skills with proven ability to use and analyse data (A), In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of Excellent IT skills with proven ability to use and analyse data and Demonstrates strong planning and organisational skills with proven ability to effectively manage changing priorities., 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 .

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 four sub-Groups, Innovation Accelerator and Regulatory Science, Clinical Investigations and Trials, Standards and Compliance and Innovative Devices.

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.