Accredited Medical Assessor - £86,000 p.a. + benefits

Job summary

We are currently looking for an Accredited Medical Assessor to join our Clinical Investigations and Trials Function within the Scientific Research and 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.

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. 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 Innovation and Compliance 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 function 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.

Job description

What’s the role?

The role encompasses a broad range of activities from assessing clinical aspects of clinical trial authorisation (CTA) applications and amendments to existing CTAs, to providing scientific advice to companies around clinical/regulatory issues for the development of new products.

The role holder will be expected to contribute to policy and strategy development to maintain and enhance the reputation of the UK as a great place to conduct clinical research, identifying synergies and opportunities for streamlining across the functional areas of the Science, Research and Innovation Group.

The role is both intellectually challenging and rewarding and provides significant opportunity for scientific and regulatory learning.

Key responsibilities:

• Carry out the 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. Prepare and present objective assessment reports or other scientific papers to expert advisory bodies.
• Manage own workload working in conjunction with the support team and other assessors to meet agency deadlines.
• Provide scientific and clinical trial expertise in advice meetings with external stakeholders, obtaining cross-agency or external support depending on the questions posed. Provide a written response to enquiries submitted through a variety of sources, including via internal customer-facing portals and the wider civil service.
• Contribute where medical input is required in critical clinical trial projects and contribute to the Innovative Licensing and Access Pathway (ILAP).

Who are we looking for?

Our successful candidate will have:

• Substantial proven experience working as a medical assessor in the assessment of Clinical Trial Authorisation (CTA) applications, making independent decisions on their suitability for approval within regulatory timelines, as well as experience providing scientific or regulatory advice. Demonstrating a consistently high level of performance in the role including a high throughput of work commensurate with experience and knowledge to meet required deadlines.
• 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.
• Up to date knowledge of relevant legislation and procedures applicable to the regulation of clinical trials.

Person specification

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation

Behaviour Criteria:

• Communicating and Influencing (A, I)
• Managing a Quality Service (A, I)
• Delivering at Pace (A, I)
• Making Effective Decisions (A, I)

Experience Criteria:

• Substantial proven experience working as a medical assessor in the assessment of Clinical Trial Authorisation (CTA) applications, making independent decisions on their suitability for approval within regulatory timelines, as well as experience providing scientific or regulatory advice. Demonstrating a consistently high level of performance in the role including a high throughput of work commensurate with experience and knowledge to meet required deadlines (A, I)

Technical Criteria:

• Degree in Medicine, registered with the General Medical Council, with a relevant postgraduate qualification and/or experience (A)
• Previous experience of the assessment of clinical aspects of a clinical trial authorisation or marketing authorisation application (A)
• Up to date knowledge of relevant legislation and procedures applicable to the regulation of clinical trials (I)

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

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Benefits

Alongside your salary of £86,000, Medicines and Healthcare Products Regulatory Agency contributes £24,914 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