Job summary
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 Science, 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 scientific expertise and 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.
Main duties of the job
Reporting to the Deputy Director on the Innovation Accelerator (IA), the successful candidate will help the delivery and coordination of subject matter expertise / advice to support the function of Innovation Accelerator and Regulatory Science and wider Agency, including practical interpretation of horizon scanning signals, strategic input into regulatory science deliverables, input into and the development of the content of regulatory and scientific enquires (and related activities) and supporting the delivery of expedited patient access pathways such as the Innovative Licensing and Access Pathway (ILAP) and the Innovative Devices Access Pathway (IDAP).
About us
- 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
- Privilege Leave: 1 day
- 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
- 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
- Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
- Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666
- Flexible working to ensure staff maintain a healthy work-life balance
- Interest free season ticket loan or bike loan
- Employee Assistance Services and access to the Civil Service Benevolent Fund
- Eligibility to join the Civil Service Motoring Association (CSMA)
- Variety of staff and Civil Service clubs
- On-going learning and development
Job description
Job responsibilities
- Application of professional expertise and knowledge in regulatory, clinical and or scientific
areas, drawing on this knowledge to support the Innovation Accelerator and Regulatory Science
function in delivering the right information at the right time to queries and requests (both
internally and externally) and supporting the ILAP ambitions.
- Develop and grow knowledge base to support broader scope of queries and the role of
Regulatory and Scientific Expert. Appreciation of different stakeholder views including industry,
academia and patients.
- Provide expert advice 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.
- Develop and build good working relationships across the agency and across related external
organisations with a strong appreciation of the wider roles and remits which ensures
coordination of activities.
- Deliver and support training and other engagement approaches for external stakeholders.
- Support the publication agenda of the IA through writing and developing documents for journals
and guidance.
Job description
Job responsibilities
- Application of professional expertise and knowledge in regulatory, clinical and or scientific
areas, drawing on this knowledge to support the Innovation Accelerator and Regulatory Science
function in delivering the right information at the right time to queries and requests (both
internally and externally) and supporting the ILAP ambitions.
- Develop and grow knowledge base to support broader scope of queries and the role of
Regulatory and Scientific Expert. Appreciation of different stakeholder views including industry,
academia and patients.
- Provide expert advice 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.
- Develop and build good working relationships across the agency and across related external
organisations with a strong appreciation of the wider roles and remits which ensures
coordination of activities.
- Deliver and support training and other engagement approaches for external stakeholders.
- Support the publication agenda of the IA through writing and developing documents for journals
and guidance.
Person Specification
Behaviours
Essential
- Making Effective Decisions - Ability to drill down quickly to the issues presented and develop a coherent message that adds value. Act decisively and make bold, unbiased decisions at a strategic level. Clearly communicate the purpose and reasons for recommendations and decisions.
- Seeing the Big Picture - Strategic thinking that will visibly expand the MHRA brand and support the IA key deliverables.
- Communicating and Influencing - Strong communication skills and ability to share information according to the audience (orally and
- written). Explaining complex issues in a way that is easy to understand
Qualifications
Essential
- Degree in Medicine with relevant postgraduate
- qualification(s) within specialist area(s). Registered
- with the General Medical Council.
- Technical Sound knowledge of relevant regulations
- applicable to the area.
Experience
Essential
- Broad and expert scientific and regulatory experience that can be applied to support the ambitions of the Innovation Accelerator.
- Experience Experience in delivering presentations. Excellent verbal and written communication skills appropriate to the target audience, including evidence of communication with patients and other
- members of the public.
- Experience Excellent interpersonal skills with demonstrable experience of facilitating team-working/team leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise.
- Experience Previous experience in a regulatory, academic or industry setting with demonstrable contribution to the innovation agenda or medical product(s)
- development activities
Person Specification
Behaviours
Essential
- Making Effective Decisions - Ability to drill down quickly to the issues presented and develop a coherent message that adds value. Act decisively and make bold, unbiased decisions at a strategic level. Clearly communicate the purpose and reasons for recommendations and decisions.
- Seeing the Big Picture - Strategic thinking that will visibly expand the MHRA brand and support the IA key deliverables.
- Communicating and Influencing - Strong communication skills and ability to share information according to the audience (orally and
- written). Explaining complex issues in a way that is easy to understand
Qualifications
Essential
- Degree in Medicine with relevant postgraduate
- qualification(s) within specialist area(s). Registered
- with the General Medical Council.
- Technical Sound knowledge of relevant regulations
- applicable to the area.
Experience
Essential
- Broad and expert scientific and regulatory experience that can be applied to support the ambitions of the Innovation Accelerator.
- Experience Experience in delivering presentations. Excellent verbal and written communication skills appropriate to the target audience, including evidence of communication with patients and other
- members of the public.
- Experience Excellent interpersonal skills with demonstrable experience of facilitating team-working/team leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise.
- Experience Previous experience in a regulatory, academic or industry setting with demonstrable contribution to the innovation agenda or medical product(s)
- development activities
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.
