JOB SUMMARY

We are currently looking for a Business Support Lead to join our Clinical Investigations and Trials Function within the Science, Research & Innovation group.
This is a full-time opportunity, on a 2 year fixed term contract/internal move or temporary promotion 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.
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.

PERSON SPECIFICATION

Our successful candidate will have:

• Effective organisational skills and ability to maintain high performance.
• Excellent communicating skills; verbal, written and presentational.
• Effective leadership skills.
• Excellent IT skills with proven ability to extract, analyse, interpret and present data.
• Significant experience of the submission and assessment requirements and associated business processes described in the Clinical Trials and Medical Device Regulations.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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SELECTION PROCESS DETAILS

We use the Civil Service Success Profiles to assess our candidates, find out more here.
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Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. 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.

• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
• 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 Excellent IT skills with proven ability to use and analyse data.
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 competency-based answers provided - ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

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)
• 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

TYPE OF ROLE

Administration / Corporate Support
Operational Delivery

WHAT’S THE ROLE?

This role will assist in the development of processes to manage the implementation of new ways of working under the applicable Clinical Trials Regulations and Medical Device Regulations.
The role will also provide line management, currently for the Application Handlers and Application Support Coordinators.

KEY RESPONSIBILITIES:

• Manage and lead on elements of the delivery of components of the project to combine the operational processes of Clinical Investigations and Clinical Trials in order to develop efficiency savings and improved ways of working. This will include monitoring the improvements and contributing to project planning.
• Lead the development of the process and IT requirements for the co-assessment of applications by the MHRA and Ethics, working in collaboration with other colleagues. This includes arranging and assisting with the testing of IT systems and developing metrics to confirm an efficient approval process.
• Line management responsibility. This includes for the Application Handlers and Application Support Coordinators, as well as providing guidance and support to other team members as required, to ensure individual and team delivery.
• Work collaboratively with the senior management of the CIT team to ensure timely delivery of Cross-Agency tasks such as scientific advice, strategy development and preparation of briefings.

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