Job summary
We are currently looking for a Pharmaceutical 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/MHRAxNp1Jl
ONLY APPLICATIONS COMPLETED ON MHRA WEBSITE WILL BE CONSIDERED
The successful candidate will 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 support the delivery of a comprehensive world leading innovative access pathway.
Main duties of the job
- Carry out the assessment of pharmaceutical quality data provided in applications to the ILAP making appropriate recommendations and decisions in line with the protection of public health.
- Involvement in the Innovative Licensing and Access Pathway (ILAP) and provision of scientific advice on the quality aspects of drug development.
- Implementation of professional expertise and knowledge in several different regulatory and scientific areas, drawing on this knowledge to support the ILAP and IA functions
- Provide reliable, timely and appropriate scientific and regulatory advice to companies at meetings 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.
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 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.
Job description
Job responsibilities
The Agency is committed to supporting Innovators of novel medical devices and medicines get accelerated patient access. As part of the Innovative Access Pathway team and under the direction of the Head of Medicines, the postholder will provide expert input in the quality assessment of medicines submitted to the Innovative Licensing and Access Pathway (ILAP).
The ILAP aims to accelerate the time to market, facilitating patient access to medicines. Following the Pro-innovation Regulation of Technologies Review: Life Sciences and the government response, the MHRA and partners AWTTC, NICE, and SMC are refreshing the ILAP, streamlining our processes.
The successful candidate will 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 support the delivery of a comprehensive world leading innovative access pathway.
Key responsibilities and results areas
Support the implementation of new processes in the ILAP to facilitate patient access to innovative medicines, including the Target Development Profile and tools.
Carry out the assessment of pharmaceutical quality data provided in applications to the ILAP making appropriate recommendations and decisions in line with the protection of public health.
Involvement in the Innovative Licensing and Access Pathway (ILAP) and provision of scientific advice on the quality aspects of drug development.
Implementation of professional expertise and knowledge in several different regulatory and scientific areas, drawing on this knowledge to support the ILAP and IA functions.
Manage own workload working in conjunction with the Operations Manager and other assessors to meet Agency deadlines.
Prepare, present, and discuss objective assessments or other scientific papers at expert advisory bodies as needed.
Provide reliable, timely and appropriate scientific and regulatory advice to companies at meetings 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.
Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
Participate in other ad-hoc tasks/projects as requested by the ILAP Head of Medicines.
Job description
Job responsibilities
The Agency is committed to supporting Innovators of novel medical devices and medicines get accelerated patient access. As part of the Innovative Access Pathway team and under the direction of the Head of Medicines, the postholder will provide expert input in the quality assessment of medicines submitted to the Innovative Licensing and Access Pathway (ILAP).
The ILAP aims to accelerate the time to market, facilitating patient access to medicines. Following the Pro-innovation Regulation of Technologies Review: Life Sciences and the government response, the MHRA and partners AWTTC, NICE, and SMC are refreshing the ILAP, streamlining our processes.
The successful candidate will 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 support the delivery of a comprehensive world leading innovative access pathway.
Key responsibilities and results areas
Support the implementation of new processes in the ILAP to facilitate patient access to innovative medicines, including the Target Development Profile and tools.
Carry out the assessment of pharmaceutical quality data provided in applications to the ILAP making appropriate recommendations and decisions in line with the protection of public health.
Involvement in the Innovative Licensing and Access Pathway (ILAP) and provision of scientific advice on the quality aspects of drug development.
Implementation of professional expertise and knowledge in several different regulatory and scientific areas, drawing on this knowledge to support the ILAP and IA functions.
Manage own workload working in conjunction with the Operations Manager and other assessors to meet Agency deadlines.
Prepare, present, and discuss objective assessments or other scientific papers at expert advisory bodies as needed.
Provide reliable, timely and appropriate scientific and regulatory advice to companies at meetings 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.
Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
Participate in other ad-hoc tasks/projects as requested by the ILAP Head of Medicines.
Person Specification
Qualifications
Essential
- Honours Degree in a relevant specialist subject with relevant postgraduate experience or PhD equivalent.
Behaviours
Essential
- Working Together: Evidence of effective interpersonal skills in a range of situations. Actively build and maintain a network of colleagues and contacts to achieve progress on shared objectives.
- Delivering at Pace: Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Communicating and Influencing - Strong communication skills and ability to shareinformation according to the audience (orally and written). Explaining complex issues in a way that is easy to understand.
Experience
Essential
- Working knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
- Experience of working as an accredited pharmaceutical/quality assessor or similar, with proven ability to handle a high throughput commensurate with experience and knowledge to meet required timelines.
Person Specification
Qualifications
Essential
- Honours Degree in a relevant specialist subject with relevant postgraduate experience or PhD equivalent.
Behaviours
Essential
- Working Together: Evidence of effective interpersonal skills in a range of situations. Actively build and maintain a network of colleagues and contacts to achieve progress on shared objectives.
- Delivering at Pace: Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Communicating and Influencing - Strong communication skills and ability to shareinformation according to the audience (orally and written). Explaining complex issues in a way that is easy to understand.
Experience
Essential
- Working knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
- Experience of working as an accredited pharmaceutical/quality assessor or similar, with proven ability to handle a high throughput commensurate with experience and knowledge to meet required timelines.
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.
