Medical Assessor - 75,585 - 84,840 p.a. + benefits

We are currently looking for a Medical Assessor to join our Innovative Medicines Function within the Health Quality and Access 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. 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 objective of the Healthcare Quality and Access Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.

The objective of the Innovative Medicines team in Healthcare, Quality and Access Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.

Whats the role?

Reporting to the Team or Function Manager in Innovative Medicines, the medical assessors are required to assess the clinical and regulatory aspects of initial and variation marketing authorisation applications for chemical or biological medicinal products, in a variety of therapeutic fields including those with new or complex issues for adult and paediatric patients.

Key responsibilities:

• Carry out the assessment of clinical data provided in marketing authorisation initial and variation applications
• Share Knowledge and Development of Self and Colleagues
• Contribute to Policy and Procedures
• Communicate with internal and external stakeholders

Who are we looking for?

Our successful candidate will demonstrate the following:

• Degree in Medicine and with a relevant postgraduate qualification within specialist area.
• Registered with the General Medical Council and holding a licence to practise or eligible and willing to obtain/reactivate a licence to practise upon joining the Agency
• Ability to critically analyse clinical/scientific information from a range of sources including clinical trials and observational studies.
• Evidence of an up-to-date specialist level knowledge and experience in one or more relevant scientific areas. Experience in the field of immunology or oncology would be advantageous, but other specialist clinical areas also welcome.
• Ability to make independent decisions on the benefit-risk balance of medicines, supported by a clear rationale.
• Good knowledge of relevant regulations applicable the licensing of medicinal products

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

Ability Criteria:

• Ability to critically analyse clinical/scientific information from a range of sources including clinical trials and observational studies. (A,I,T)
• Ability to make independent decisions on the benefit-risk balance of medicines, supported by a clear rationale. (A,I,T)

Behaviour Criteria:

• Managing a Quality Service (A,I)
• Delivering at Pace (A,I)
• Communication and Influencing (A,I)

Experience Criteria:

• Clinical, academic or pharmaceutical medicine experience, including evidence of analysis of complex data, decision-making, and preparation of comprehensive, authoritative reports, scientific publications or regulatory submissions (A,I)
• Excellent verbal and written presentation skills appropriate to the target audience including evidence of communication with patients and other members of the public, and expert medical groups and committees. (A,I)
• Excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise. (A,I)

Technical Criteria:

• Degree in Medicine and with a relevant postgraduate qualification within specialist area. (A)
• Registered with the General Medical Council (GMC) and holding a licence to practise or eligible and willing to obtain/reactivate a licence to practise upon joining the Agency (A)
• Evidence of an up-to-date specialist level knowledge and experience in one or more relevant scientific areas. Experience in the field of immunology or oncology would be advantageous, but other specialist clinical areas also welcome. (A,I)
• Good knowledge of relevant regulations applicable the licensing of medicinal products (A,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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