Medicines and Healthcare products Regulatory Agency
Change Advisor - £37,456 - £42,084 p.a. + benefits
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Job Summary
We are currently looking for a Change Advisor to join our Data Assurance & Quality Function within the Health Quality and Access group.
This is a full-time opportunity, on a fixed term contract until 30th June 2027, internal move, temporary promotion, loans will be considered. 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. 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 Authorisation Lifecycle Group is a key division within the Healthcare Quality and Access group at the UK Medicines and Healthcare products Regulatory Agency (MHRA). It operates as the "front door" to the agency, managing the initial receipt and validation of license applications, as well as the post-authorisation changes that occur throughout a drug’s commercial life.
The MHRA’s Data Assurance & Quality (DAQ) is responsible for initial data entry of regulatory applications onto the Agency’s computer systems. The unit has around 60 data processing staff and processes over 100,000 items of work per year. Operational management of this area can be complex as the applications are of various types, their volumes fluctuate often unpredictably from week to week and there are many different processing targets. The Change Control Officer will support the Continuous Improvement function of the unit including Training, Error reporting, and Change control.
Job Description
Role Purpose
The role is within the Data Assurance & Quality (DAQ) unit which is responsible for the regulatory validation and data management of a wide variety of regulatory submissions received from the pharmaceutical and medical device’s sectors. The Change Advisor reports directly to the Continuous Improvement Lead. The team is responsible for controlling the unit’s procedures and for the delivery of the unit’s process review function, providing a constant drive to improve performance and quality and maximise efficiency within the unit. In delivering this outcome, the Change Advisor will play an important role in the change control of DAQ processes, quality monitoring and in the coordination of staff training and cross-skilling. The DAQ Change Advisor will work with the Head of Continuous Improvement & Reform (CIR) & CI Lead in delivering the wider drive towards process excellence in the Unit and wider Agency.
Change advisors support project delivery, ensuring any tasks given are planned, executed, and completed on time, within scope, and aligned with business objectives. They will collaborate with cross functional teams to define project requirements. Drive continuous improvement by identifying opportunities to enhance processes, implement sustainable solutions, and deliver measurable business benefits while maintaining high standards of quality and compliance.
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The post offers the opportunity to work within a high performing and motivated team in a high-profile area of work and to play a key role in achieving the wider Agency targets. Additionally, the post holder will play a key role in process and training development within the Data Assurance & Quality (DAQ).
Key Responsibilities And Results Areas
- Working closely with CI Lead to ensure the DAQ processes and procedures are constantly monitored and developed to maximal efficiency.
- Assist the CI Lead with the change control of DAQ processes, quality monitoring and assisting in the coordination of staff training and cross-skilling ensuring all administrative tasks are kept up to date.
- Support the delivery of three core activities; unit support for new and existing staff, core skill training to cover activities required for DAQ unit to function and personal development training across the unit.
- Take ownership and responsibility to ensure training and assessments are fully completed as well as any updates to SOPs are actioned and completed on time.
- Maintain all training documents, SOPs and records in a consistent manner ensuring the appropriate sign off and governance is followed at all levels at all times.
- Inform management where decisions are needed for new and existing staff regarding sufficient progress to justify progression from probation periods and to provide evidence of training provided in disciplinary and/or performance issues.
- Ensure that CIR related queries are answered within target times and liaise with agency colleagues to address and resolve queries related to processing errors.
- Assist in the planning, coordination, and execution of projects, ensuring activities are completed on time, within scope, and aligned with business objectives.
Management and Leadership
- Report to the CI Lead providing input and feedback as a member of the CIR team.
- Regularly review procedures or systems with CI lead to identify improvements and simplify processes and decision-making improving performance, quality and customer service.
- Work with the senior classifiers to constantly ensure that work is delivered to a high-quality standard and in a timely manner.
- Identify and take ownership of issues with stakeholders through to resolution.
Performance Management
- Work closely with Head of Continuous Improvement & Reform (CIR) and CI Lead to control the unit’s procedures, minimising variability, maximising operational efficiency and ensuring appropriate evaluation and control of change is in place.
- Identify and develop all talented team members to support succession planning, devoting time to coach, mentor and develop others.
- Invite challenge and where appropriate involve others in decision making to help build engagement and present robust recommendations.
Organisational Performance and Delivery
- Ensure delivery of the Unit’s strategy, business plan, service level agreements and objectives.
- Contribute to process improvement and development.
Person specification
Experience
- Experience of project or change management or working within quality systems.
- Experience of working in a regulatory environment.
Behaviours
We'll assess you against these behaviours during the selection process:
- Changing and Improving
- Managing a Quality Service
- Delivering at Pace
- Communicating and Influencing
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Technical skills
We'll assess you against these technical skills during the selection process:
- Some understanding of the medicines and medical devices regulatory environment.
- Proven ability to apply Lean, Six Sigma, and structured problem solving methodologies to drive process improvements.
Benefits
- Alongside your salary of £37,456, Medicines and Healthcare Products Regulatory Agency contributes £10,851 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
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
This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours, Strengths, Experience and Technical skills.
We use the Civil Service Success Profiles to assess our candidates, find out more here.
- 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.
- An anonymised CV outlining your job history and previous skills/experience.
- 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: Experience of project or change management or working within quality systems
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-
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