Medical Assessor G6 £73,324 + Benefits

Job description

Job responsibilities

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.

About the Group

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.

Role Purpose

Reporting to the Team or Function Manager in Innovative Medicines, the medical assessor is 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.

Commensurate with seniority and experience, the assessor will be contributing to the Agencys wider innovation activities and ensuring that safe and effective medicinal products continue to become available to UK patients promptly. They will analyse evidence from a range of sources as well as take into account stakeholders and patients views through more complex assessments and wider activities associated with this work.

The post holder will be working in the team designated, for example biologicals or new active substances, but will also collaborate across the Innovative Medicines and Establish Medicines Functions, using matrix functioning principles to evaluate applications of other product types, including established medicines, where appropriate.

The post offer career development and progression opportunities in line with our internal development programme.

Key responsibilities

Assessment of Applications

Carry out the assessment of clinical data provided in marketing authorisation initial and variation applications (including applications made through the Early Access to Medicine Scheme and Innovative Licensing and Access Pathway) and/or paediatric data from various sources (e.g. paediatric investigation plans), including data with new, wide-ranging, or complex issues, making appropriate recommendations and decisions aligned with the protection of public health.

Manage own workload working in conjunction with other assessors to meet agreed timelines responding to public health demands

Prepare present and discuss objective assessments or other scientific papers at expert advisory groups, e.g., Commission on Human Medicines as needed

Take a lead in providing reliable, timely and appropriate scientific and regulatory advice to companies and in writing reflecting contemporary regulatory guidance and relevant regulatory decisions. Advice should be given in line with protection of public health and to promote innovation, specifically to promote efficient development without compromising the evidence base for regulatory decision making.

Sharing Knowledge and Development of Self and Colleagues

Commensurate with experience, mentor or coach other staff to enhance their knowledge and contribution

Provide advice to colleagues in the division or Agency as needed

Continues to extend and deepen skills and knowledge in relevant scientific or professional area.

Contribution to Policy and Procedures

• Contribute to and influence assessment policy and practice, and proactively identify where such contributions would be beneficial
• Contribute to and influence divisional procedures
• Make individual contributions to representational or professional activities inside or outside the Agency
• Support and develop interactions with international regulators, both for assessments and regulatory science

Communication with Stakeholders

• Develop good working relationships with colleagues and with internal and external stakeholders
• Deal effectively with official correspondence to agreed timelines

Management and Use of Resources

• Use own and Agency resources in line with Agency and divisional strategy to meet targets
• Provide support when required to assist other Functions and Agency teams

Person Specification

Qualifications

Essential

• Degree in Medicine and with a relevant postgraduate qualification within specialist area. Registered with the General Medical Council.

Experience

Essential

• Managing a Quality Service
• Deliver at Pace
• Communicating and Influencing
• Clinical, academic or pharmaceutical medicine experience, including evidence of analysis of data and preparation of reports, scientific publications or regulatory submissions.
• Excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise.
• Degree in Medicine and with a relevant postgraduate qualification within specialist area. Registered with the General Medical Council.
• Evidence of an up-to-date specialist level knowledge in one or more relevant scientific areas

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU

Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)