Clinical Pharmacology Assessor - £58,983 p.a. + benefits
Medicines and Healthcare products Regulatory Agency, City of Westminster
Clinical Pharmacology Assessor - £58,983 p.a. + benefits
Salary not available. View on company website.
Medicines and Healthcare products Regulatory Agency, City of Westminster
- Full time
- Temporary
- Onsite working
Posted today, 4 Dec | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
job Ref: 7d619d5b5f0e4c1a84dc3a360413c315
Full Job Description
We are currently looking for a Clinical Pharmacology 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 Clinical Pharmacology group assess the pharmacokinetics and pharmacodynamic aspects of product licensing applications, Early Access to Medicines (EAMs), Innovative Licensing and Access Pathway (ILAP) or clinical trials applications for medicinal products and amendments including those with new or complex issues and takes decisions on their suitability for approval.
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 products 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 the Clinical Pharmacology Team. This role encompasses the evaluation of a range of new chemical and biological products, including new active substances, at different stages of development.
The reports written and recommendations made will be highly influential in initiating trials of new medicines and taking these through clinical development and/or allowing new medicines to be made widely available to patients.
Person specification
Service delivery
+ Carry out the assessment of data provided in marketing authorisation and clinical trial authorisation applications for chemical and biological products making appropriate recommendations and decisions in line with the protection of public health.
+ Involvement in the Innovative Licensing and Access Pathway (ILAP), Early Access to Medicines (EAMs) scheme and provision of scientific advice on the non-clinical aspects of drug development.
+ Manage own workload working in conjunction with other assessors to meet agency deadlines
+ Prepare and present objective assessments or other scientific papers to expert advisory bodies
Service improvement
+ Contribute to assessment policy and practice and proactively identify where such contributions would be beneficial
+ Contribute to divisional procedures and proactively identify where such contributions would be beneficial
Quality and Assurance
+ Promptly update agency, divisional or team, work management databases to reflect the progress of own work
+ Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases.
+ Use own and agency resources in line with agency and divisional strategy to meet targets
Leadership and management
+ Develop to provide ad hoc advice to colleagues in the Division or Agency
+ Extend and deepen skills and knowledge in relevant scientific or professional areas
General
+ 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 Unit Manager
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk, 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 Test, further information will be 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).
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 £58,983, Medicines and Healthcare Products Regulatory Agency contributes £17,087 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
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