Logo of Huzzle

Home

Matches

Explore

Manage

Senior Medical Assessor

image

Medicines and Healthcare products Regulatory Agency

12d ago

  • Job
    Full-time
    Senior Level
  • Science
    Research & Development
  • London
  • 5d left

AI generated summary

  • You need a medical degree, GMC registration, relevant postgraduate qualifications, clinical trial assessment experience, and the ability to meet deadlines while adhering to legal regulations.
  • You will assess clinical trial data, advise stakeholders, chair meetings, develop relationships, mentor colleagues, and contribute to regulatory projects and policy related to clinical trials.

Requirements

  • 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

Responsibilities

  • 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.

FAQs

Do we support remote work?

Yes, we support remote work in a hybrid format, with a minimum of 8 days per month required on-site.

What are the primary responsibilities of a Senior Medical Assessor?

The primary responsibilities include the risk-based assessment of clinical trial authorization applications, providing scientific and clinical trial expertise in meetings, developing relationships with stakeholders, and contributing to regulatory work relevant to clinical trials.

What qualifications are required for this role?

A degree in Medicine registered with the General Medical Council, along with relevant postgraduate qualifications and/or experience in assessing clinical trials or marketing authorization applications.

What is the location of this position?

This position is based at 10 South Colonnade, Canary Wharf, London, E14 4PU.

Is this position available for candidates outside the UK?

No, this role can only be worked in the UK and not overseas.

What is the closing date for application submissions?

The closing date for applications is 22 May 2025.

What does the selection process involve?

The selection process includes an online application form, a CV, a statement of suitability, and an interview that may extend to Behaviour, Experience, Technical, and Strengths Success Profiles.

What kind of experience is preferred for applicants?

Previous experience in the assessment of clinical aspects of clinical trial authorization or marketing authorization applications, as well as familiarity with the design, conduct, and analysis of clinical trials.

Is there an opportunity for mentorship in this role?

Yes, the role includes responsibilities for mentoring and training activities for new or non-accredited assessors.

How does one apply for this role?

Applicants should submit their application via the Oracle Recruit system, including a CV, a supporting statement, and, if applicable, a manager's endorsement form.

image

Medicines and Healthcare products Regulatory Agency

Protecting and improving public health and supporting innovation through scientific research and development.

Government
Industry
1001-5000
Employees
2003
Founded Year

Mission & Purpose

The Medicines and Healthcare products Regulatory Agency, an executive agency of the Department of Health and Social Care, exists to 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. We deliver this through three distinct yet complimentary business centres: the MHRA regulatory centre, the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). With a range of interesting specialist opportunities on offer, with plenty of scope to develop your career within a leading and multifaceted scientific organisation, why not consider a career with us at our offices in central London or Hertfordshire.