JOB SUMMARY

We are currently looking for a Senior Medical Assessor to join our Clinical Trials Team within the Science, Research & Innovation group.
This is a full-time opportunity, on a permanent 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.

JOB DESCRIPTION

• Risk-based assessment of data provided in clinical trial authorisation initial and amendment applications for chemical, biological or advanced therapy products making appropriate recommendations and decisions in line with the protection of public health. This will include consideration of the assessment from peers in other disciplines (including pharmaceutical quality and non-clinical) and will involve discussion with them on occasion. Prepare and present objective assessment reports and other scientific papers, for example for expert advisory bodies.
• Provide scientific and clinical trial (CT) expertise in advice meetings with external stakeholders, requesting cross-agency or external support depending on the questions posed. Take a leading role in meetings including as meeting chair when required. Provide a written response to questions for specific meetings, and also to other enquiries through a variety of sources, including via internal customer-facing portals and the wider civil service.
• Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders. This includes with senior managers and senior colleagues across the civil service, as well as across the research community and in a global forum. Manage any roles that matrix work into CT medical assessor working, such as leading the team when required, mentoring and playing active role in the training activities and development of new or non-accredited assessors.
• Provide input to wider regulatory work that is relevant to CT and where CT-specific expertise is required, including UK and global projects. This includes contributing to assessment policy and practice and proactively identifying where such contributions would be beneficial. Take a leading role in projects where a clinical lead is appropriate and provide input to key decision-making situations. Ability to support work across other units and groups in the Agency, providing CT expertise when required, for example to support Good Clinical Practice (GCP) aspects of trial conduct.

PERSON SPECIFICATION

Our successful candidate will have:

• A degree in Medicine, registered with the General Medical Council, with a relevant postgraduate qualification and/or experience
• Previous experience of the assessment of clinical aspects of a clinical trial authorisation or marketing authorisation application
• Experience in the assessment of the design, conduct and analysis of clinical trials and/or experience in the preparation of study reports or reviews of clinical data for publication or regulatory submission
• Ability to handle through output of work commensurate with experience and knowledge to meet required deadlines while maintaining adherence to legal and regulatory requirements

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

WHAT’S THE ROLE?

Medical Assessors are responsible for the assessment of medical aspects of clinical trial authorisation (CTA) applications and amendments, taking decisions on their suitability for approval, and working mostly within a highly skilled multidisciplinary team.
The role encompasses a broad range of activities from assessing a CTA application for a new chemical or biological active substance, to providing scientific advice to companies around medical and regulatory issues for the development of new drug products.