Job summary
We are currently looking for a Leading Medical Assessor to join Innovative Medicines Function within the Healthcare 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. Please be aware that this role can only be worked in the UK and not overseas. �
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.
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 Innovative Medicines function delivers a risk appropriate critical appraisal of quality, safety and efficacy of innovative medicinal products, determining whether a product�s benefits outweighs the risks. It aims to accelerate their route to market to drive earlier patient access. Through this function the Agency will be seen as a leader in facilitating early access to safe and innovative medicines attracting the life sciences sector and contributing to a positive patient experience and to the improvement of public health outcomes.
Job description
Reporting to the Team or Function Manager in Innovative Medicines, the leading senior medical assessor is required to provide a lead across the Innovative Medicines group in the assessment of the regulatory and scientific aspects of the most challenging procedures especially those with innovative or complex issues for adult and paediatric patients.
1. Working with less experienced colleagues and across teams as required, act as the lead assessor, or advising assessor (as appropriate) for marketing authorisation initial and variation applications, or paediatric investigation plans and waivers.� In particular those with new, wide-ranging or complex issues and those having broader implications for national or international policy or public health, resolving challenges to make appropriate recommendations and decisions in line with the protection of public health.�
2. Manage own workload working in conjunction with other assessors to meet agreed timelines responding to public health demands
3. Prepare present and discuss objective assessments or other scientific papers at expert advisory groups,, Commission on Human Medicines as needed
4. 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.�
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Person specification
5. Degree in Medicine and with a relevant postgraduate qualification. Registered to practice clinical medicine. ��
6. Leading Senior Assessors will be recognised as having extensive regulatory experience and understanding of the operation of UK and international regulation as well as professional or scientific expertise in their discipline. They will make a significant contribution to the group and Agency through wider activities associated with their work, across teams as necessary.
7. Proven ability to work very largely independently and effectively to evaluate and provide insight into the most complex assessments including those with new or wide-ranging issues under pressure, using evidence from a number of sources to make appropriate recommendations or decisions in line with the protection of public health.
8. Knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
9. Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
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Benefits
Alongside your salary of �76,000, Medicines and Healthcare Products Regulatory Agency contributes �22,017 towards you being a member of the Civil Service Defined Benefit Pension scheme.
10. 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�
11. Privilege Leave: 1 day��
12. 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�
13. 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�
14. Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
15. Civil Service Pension Scheme.� Please see the link for further information For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666�
16. Flexible working to ensure staff maintain a healthy work-life balance�
17. Interest free season ticket loan or bike loan�
18. Employee Assistance Services and access to the Civil Service Benevolent Fund�
19. Eligibility to join the Civil Service Motoring Association (CSMA)
20. Variety of staff and Civil Service clubs�
21. On-going learning and development�
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