Medicines and Healthcare products Regulatory Agency
Quality Assessor - £60,778 - £68,422 p.a. + benefits
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Job Summary
We are currently looking for a Quality Assessor to join our Innovative Medicines Team Function within the Health 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.
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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.
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 (HQA) portfolio 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 – Unlicensed Medicine function, part of HQA, delivers a risk-based appraisal of Unlicensed medicines and whether they may or may not be supplied within the UK, to safeguard public health. It enables wider access to these important medicines when licensed medicines are not available to meet the needs of individual patients.
Job Description
What’s the role?
Quality Assessors form part of multidisciplinary teams and will specifically assess the quality aspects of initial applications for the marketing authorisation (MA) of biological medicinal products and subsequent variations to existing MAs.
They are responsible for providing scientific and regulatory advice to internal and external stakeholders, supporting UK healthcare innovation of biological medicinal products. Assessors will also be expected to participate in non-assessment activities such as maintaining and developing regulatory and scientific guidance and engaging with stakeholders to deliver wider agency goals.
Key Responsibilities:
- Carry out the assessment of data provided in initial and variation marketing authorisation applications for biological products, making appropriate recommendations and decisions in line with the protection of public health.
- Prepare and present objective risk-based assessments or other scientific papers to expert advisory bodies.
- Manage own workload, working in conjunction with managers, support staff and other assessors to meet agency deadlines.
- Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases.
- Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
Who are we looking for?
Our Successful Candidate Will Demonstrate The Following:
- Degree and postgraduate degree in a relevant biological science, such as biochemistry, molecular biology, immunology, cell biology, pharmacy. PhD or equivalent experience is preferred.
- In depth experience in: regulatory affairs, research and development, manufacture or quality control of biological medicinal products within the pharmaceutical/biotechnology industry or academia (or equivalent).
- Up to date, detailed, specialist level of knowledge in one or more relevant scientific areas and broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of biological medicinal products.
- Experience communicating technical information accurately and effectively to relevant parties evidencing excellent written and verbal communication skills.
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Working Together
What’s the role?
Quality Assessors form part of multidisciplinary teams and will specifically assess the quality aspects of initial applications for the marketing authorisation (MA) of biological medicinal products and subsequent variations to existing MAs.
They are responsible for providing scientific and regulatory advice to internal and external stakeholders, supporting UK healthcare innovation of biological medicinal products. Assessors will also be expected to participate in non-assessment activities such as maintaining and developing regulatory and scientific guidance and engaging with stakeholders to deliver wider agency goals.
Our Successful Candidate Will Demonstrate The Following:
- Degree and postgraduate degree in a relevant biological science, such as biochemistry, molecular biology, immunology, cell biology, pharmacy. PhD or equivalent experience is preferred.
- In depth experience in: regulatory affairs, research and development, manufacture or quality control of biological medicinal products within the pharmaceutical/biotechnology industry or academia (or equivalent).
- Up to date, detailed, specialist level of knowledge in one or more relevant scientific areas and broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of biological medicinal products.
- Experience communicating technical information accurately and effectively to relevant parties evidencing excellent written and verbal communication skills.
Person specification
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
- Making Effective Decisions (A,I)
- Working Together (A,I)
- Managing a quality Service (A,I)
Experience Criteria:
- Ability to handle throughput of work commensurate with experience and knowledge to meet required deadlines. (A,I)
- In depth experience in: regulatory affairs, research and development, manufacture or quality control of biological medicinal products within the pharmaceutical/biotechnology industry or academia (or equivalent). (A,I)
- Demonstrable experience of developing successful relationships with both internal and external stakeholders, with excellent communication skills. (A,I)
- Experience communicating technical information accurately and effectively to relevant parties evidencing excellent written and verbal communication skills. (A,I)
Technical Criteria:
- Degree and postgraduate degree in a relevant biological science, such as biochemistry, molecular biology, immunology, cell biology, pharmacy. PhD or equivalent experience is preferred. (A)
- Up to date, detailed, specialist level of knowledge in one or more relevant scientific areas and broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of biological medicinal products. (A,I,T)
- Keen attention to detail, a proven ability to apply critical thinking to complex problems. (A,I,T)
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If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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Alongside your salary of £60,778, Medicines and Healthcare Products Regulatory Agency contributes £17,607 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).
- 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 Motoring, Boundless by CSMA
- Variety of staff and Civil Service clubs
- On-going learning and development
Artificial intelligence
Artificial intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance (opens in a new window) for more information on appropriate and inappropriate use.
Selection process details
We use the Civil Service Success Profiles to assess our candidates, find out more here.
- Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
- Test, further information will be supplied when you reach this stage
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
In The Instance That We Receive a High Number Of Applications, We Will Hold An Initial Sift Based On The Lead Criteria Of:
- Degree and postgraduate degree in a relevant biological science, such as biochemistry, molecular biology, immunology, cell biology, pharmacy. PhD or equivalent experience is preferred.
- In depth experience in: regulatory affairs, research and development, manufacture or quality control of biological medicinal products within the pharmaceutical/biotechnology
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