Job summary
We are currently looking for a Medical Assessor to join our Innovation Accelerator Function within the Scientific Research and Innovation group.
This is a full-time opportunity, on a fixed term contract basis until 31 March 2025. 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. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 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 8 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.
TO BE CONSIDERED FOR THIS ROLE, PLEASE COMPLETE YOUR APPLICATION ON MHRA WEBSITE http://lhrc1a.rfer.us/MHRA0FI1Je
ONLY APPLICATIONS COMPLETED ON MHRA WEBSITE WILL BE CONSIDERED
Main duties of the job
The successful candidate will lead a team of experts and work in a matrix model across the Agency with experts in Healthcare Quality and Access, Safety and Surveillance, Science, Research and Innovation and Partnerships to deliver a comprehensive world leading innovative access pathway.
About us
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 Scientific Research and Innovation Group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.
The Innovation Accelerator (IA) provides innovators access to the Agencys scientificexpertiseand regulatory guidance, helping developers of innovative products (medicines, medical devices (including software) and blood components for transfusion) connect more dynamically with an enhanced advice and signposting service.
Job description
Job responsibilities
- Implement and support on new processes in the ILAP to facilitate patient access to innovative medicines, including the Target Development Profile and tools.
- Develop and maintain close working relationships with external partners at the AWTTC, NICE, and SMC as a key member of the ILAP Delivery Group.
- Draw upon specialist expertise to carry out the assessment of clinical data provided in applications to the ILAP including those with new, wide-ranging or complex issues making appropriate recommendations and decisions in line with the protection of public health.
- Provide expert clinical advice and guidance to external stakeholders / requesters, ensuring that the advice adds value to the information that is currently available in the public domain and signposts to MHRA services generating new and ongoing business.
- Unpick complex queries and develop a strategic approach to the response, signposting to relevant agency services and functions.
- Thoroughly analyse data and evidence from a range of sources to make sound recommendations and minimise risks.
- Implementation of professional expertise and knowledge in several different regulatory and scientific areas, drawing on this knowledge to support the ILAP and IA functions in delivering the right information at the right time to queries and requests (both internally and externally). Take a lead in providing reliable and appropriate medical expertise in advice meetings.
- Prepare, present, and discuss objective assessments or other scientific papers at expert advisory bodies as needed.
Job description
Job responsibilities
- Implement and support on new processes in the ILAP to facilitate patient access to innovative medicines, including the Target Development Profile and tools.
- Develop and maintain close working relationships with external partners at the AWTTC, NICE, and SMC as a key member of the ILAP Delivery Group.
- Draw upon specialist expertise to carry out the assessment of clinical data provided in applications to the ILAP including those with new, wide-ranging or complex issues making appropriate recommendations and decisions in line with the protection of public health.
- Provide expert clinical advice and guidance to external stakeholders / requesters, ensuring that the advice adds value to the information that is currently available in the public domain and signposts to MHRA services generating new and ongoing business.
- Unpick complex queries and develop a strategic approach to the response, signposting to relevant agency services and functions.
- Thoroughly analyse data and evidence from a range of sources to make sound recommendations and minimise risks.
- Implementation of professional expertise and knowledge in several different regulatory and scientific areas, drawing on this knowledge to support the ILAP and IA functions in delivering the right information at the right time to queries and requests (both internally and externally). Take a lead in providing reliable and appropriate medical expertise in advice meetings.
- Prepare, present, and discuss objective assessments or other scientific papers at expert advisory bodies as needed.
Person Specification
Behaviours
Essential
- Making Effective Decisions critically analyse clinical/scientific information from a range of sources including case reports, clinical trials and observational studies, make sound judgements for recommendations to protect patient safety and public health. Use evidence and knowledge to support accurate, expert decisions and advice. Carefully consider alternative options, implications and risks of decisions.
- Delivering at Pace evidence of ability to work in a pressurised, target driven environment, delivering results on time within a range of deadlines maintaining high standards of quality. Evidence of flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Managing a Quality Service - Creates regular opportunities for colleagues, stakeholders, delivery partners and customers through the use of strategic thinking that helps improve the quality ofservice and visibly expands the MHRA brand and supports the Innovation Accelerator key deliverables and objectives.
Experience
Essential
- Experience of working as a medical assessor or similar, with proven ability to handle a high throughput commensurate with experience and knowledge to meet required timelines.
- Proven experience of and ability to work largely independently and effectively to evaluate and provide insight into the 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.
- Evidence of comprehensive and up-to-date specialist level of knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities
- Evidence of being able to effectively use knowledge and skills to develop and mentor others
- In depth knowledge and understanding of regulation and guidance on medicines.
- Extensive experience in drug development or regulation and evidence of sound judgement in the assessment of medicinal products
Qualifications
Essential
- Degree in Medicine and with a relevant postgraduate qualification. Registered to practice clinical medicine.
Person Specification
Behaviours
Essential
- Making Effective Decisions critically analyse clinical/scientific information from a range of sources including case reports, clinical trials and observational studies, make sound judgements for recommendations to protect patient safety and public health. Use evidence and knowledge to support accurate, expert decisions and advice. Carefully consider alternative options, implications and risks of decisions.
- Delivering at Pace evidence of ability to work in a pressurised, target driven environment, delivering results on time within a range of deadlines maintaining high standards of quality. Evidence of flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Managing a Quality Service - Creates regular opportunities for colleagues, stakeholders, delivery partners and customers through the use of strategic thinking that helps improve the quality ofservice and visibly expands the MHRA brand and supports the Innovation Accelerator key deliverables and objectives.
Experience
Essential
- Experience of working as a medical assessor or similar, with proven ability to handle a high throughput commensurate with experience and knowledge to meet required timelines.
- Proven experience of and ability to work largely independently and effectively to evaluate and provide insight into the 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.
- Evidence of comprehensive and up-to-date specialist level of knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities
- Evidence of being able to effectively use knowledge and skills to develop and mentor others
- In depth knowledge and understanding of regulation and guidance on medicines.
- Extensive experience in drug development or regulation and evidence of sound judgement in the assessment of medicinal products
Qualifications
Essential
- Degree in Medicine and with a relevant postgraduate qualification. Registered to practice clinical medicine.
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.
