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About the Role
The Medical Assessor will assess the clinical and regulatory aspects of marketing authorisation applications for medicinal products, contributing to robust decisions on healthcare access.
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
Requirements
- Degree in Medicine with a relevant postgraduate qualification within a 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 up-to-date specialist level knowledge and experience in one or more relevant scientific areas
- Experience in immunology or oncology would be advantageous, but other specialist clinical areas are 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 to the licensing of medicinal products
- 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
- 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
- Excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise
- Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks
- Successful candidates must complete basic personnel security standard checks
- Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements
Skills
- Critical analysis of clinical/scientific information
- Independent decision-making on benefit-risk balance
- Communication and influencing
- Managing a quality service
- Delivering at pace
- Verbal and written presentation skills
- Interpersonal skills
Location
- 10 South Colonnade, Canary Wharf London, E14 4PU
Work Type
- Full-time
- Permanent
- Hybrid
Experience Level
- Specialist level knowledge and experience
Education Level
- Degree in Medicine
- Relevant postgraduate qualification within specialist area
About the Company
- The Medicines and Healthcare products Regulatory Agency enhances and improves the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
- The agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.
- The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.
Equal Opportunity
- In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition.