Low Risk Assessor Manager

2 weeks ago


London, Greater London, United Kingdom UK Civil Service Full time

Job summary

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?

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 function within the Science, 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 3 sub-Groups, Innovation Accelerator and Regulatory Science, Clinical Investigations and Trials and Standards and Compliance.

The Clinical Investigations and�Trials�team 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.�

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.

Job description

�- 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.

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.

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.

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.

Person specification

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

Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact�

Benefits

Alongside your salary of �56,353, Medicines and Healthcare Products Regulatory Agency contributes �15,215 towards you being a member of the Civil Service Defined Benefit Pension scheme. 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 ServiceFlexible 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 the Civil Service Motoring Association (CSMA)Variety of staff and Civil Service clubs�On-going learning and development�
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