Non-Clinical assessor - £56,353 p.a. + benefits

Medicines and Healthcare products Regulatory Agency

Non-Clinical assessor - £56,353 p.a. + benefits

£56353

Medicines and Healthcare products Regulatory Agency, City of Westminster

  • Full time
  • Temporary
  • Onsite working

Posted 1 week ago, 6 Sep | Get your application in now before you're too late!

Closing date: Closing date not specified

job Ref: c71799a065fe43f09e32ef05753ccf1e

Full Job Description

We are currently looking for a Non-Clinical assessor to join our 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 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 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., Reporting to the Head of Non-clinical Team, Non-clinical Assessors assess the pre-clinical aspects of marketing authorisation and clinical trial applications for medicinal products and take decisions on their suitability for approval.
+ Carry out the assessment of data provided in marketing authorisation applications and clinical trial authorisations for chemical and biological products making appropriate recommendations and decisions in line with the protection of public health.
+ Manage own workload working in conjunction with service coordinators and other assessors to meet agency deadlines.
+ Prepare and present objective assessments or other scientific papers to expert advisory bodies.
+ Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases., We use the Civil Service Success Profiles to assess our candidates, find out more here.
o 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.
o Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
o Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.
Use of AI in Job Applications
Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own., o UK nationals
o nationals of the Republic of Ireland
o nationals of Commonwealth countries who have the right to work in the UK
o nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
o nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
o individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
o Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service
Further information on nationality requirements (opens in a new window)

Working for the Civil Service
The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion
The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

o Degree in toxicology or other appropriate life science.
o Previous experience in one of the following; toxicology or non-clinical regulatory affairs, within the pharmaceutical industry, governmental departments or academia.
o Up to date specialist level of knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products.
o Knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
o Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome., Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Alongside your salary of £56,353, Medicines and Healthcare Products Regulatory Agency contributes £16,325 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.
o 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
o Privilege Leave: 1 day
o 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
o 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
o Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
o 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
o Flexible working to ensure staff maintain a healthy work-life balance
o Interest free season ticket loan or bike loan
o Employee Assistance Services and access to the Civil Service Benevolent Fund
o Eligibility to join the Civil Service Motoring Association (CSMA)
o Variety of staff and Civil Service clubs
o On-going learning and development