Low Risk Assessor Manager

at  Medicines and Healthcare products Regulatory Agency

We are currently looking for a Low Risk Assessor Manager to join our Clinical Investigations & Trials team within the Science, Research & Innovation group.
This is a full-time opportunity, on a fixed term contract/internal move or temporary promotion basis until 31 March 2025. 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.

WHO ARE WE LOOKING FOR?

Our successful candidate will have:

• A degree in a life science, (MSc or PhD would be advantageous), and/or experience in clinical trials from working in the pharmaceutical industry or academia.
• Excellent planning and organisational skills with proven ability to effectively manage changing priorities.
• Confidence and ability to work in a pressurised, target driven environment, whilst maintaining high standards of quality and accuracy.
• Strong customer service skills, with significant experience in communicating scientific and technical information effectively and building relationships with a wide range of stakeholders both internally and externally.
• Excellent IT skills with proven ability to use and analyse data to support decision making and implement solutions.

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 of no more than 1000 words demonstrating how you meet the Behaviour, Experience and Technical criteria on 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.

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.

WHAT’S THE ROLE?

The role holder will be responsible for leading and manging a team of five engaging in triaging, assessment and authorisation of certain low risk clinical trial authorisation applications and amendments across required functions, with the aim of ensuring the protection of those participating in clinical trials and leading in the implementation of the Notification Scheme for low-risk trials including communications with internal and external stakeholders.

KEY RESPONSIBILITIES:

1. Lead the low risk assessment team in implementing a risk proportionate approach to authorisation of low risk clinical trial authorisation applications and amendments across required functions, with the aim of ensuring the protection of those participating in clinical trials and meeting Agency and statutory deadlines.
2. Utilise experience in assessing clinical trials to analyse and interpret data, provide high quality advice and respond to complex queries. Address day to day operational and service issues as they arise and identify and implement best practice improvements.
3. Provide critical input and leads the implementation of the management of the low risk assessments in the forthcoming Clinical Trials regulations and contributing towards education materials for stakeholders including relevant guidance and support the management of clinical trial enquiries and official correspondence as required.
4. Line manage a team of five staff including low risk Assessors who review certain initial and amendment Clinical Trials applications. This includes coaching, identifying learning and development opportunities within the team and setting performance management standards and ensuring effective management in accordance with HR policies.