Good Clinical Practice Inspector - £52,603 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency
Apply before 11:55 pm on Tuesday 1st October 2024
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About the job
Job summary
We are currently looking for a Good Clinical Practice Inspector to join our Standards and Compliance Function within the Healthcare Quality and Access group.
This is a full-time opportunity, on a permanent basis. The role will be homebased . Please be aware that this role can only be worked in the UK and not overseas.
Although the role is homebased there will be a requirement to attend our offices for meetings at 10 South Colonnade, Canary Wharf, London, E14 4PU and Blanche Lane, South Mimms, Potters Bar EN6 3QG. The role also requires significant travel around the UK and overseas travel is dependent on the technical area but is on average a maximum of 4-6 trips per year.
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.
Job description
The postholder will be a part of the GCP Compliance Team whose remit is to perform inspections at a wide range of sites in the UK (and potentially overseas) to assess the compliance of organisations with their legal obligations. The role also involves engaging with stakeholders across a variety of platforms to help improve industry compliance and contribute to safeguarding public health.
As a Good Clinical Practice (GCP) Inspector, you will be part of a dynamic and supportive team. In your role, you will have autonomy in how to plan and structure your day-to-day work, including inspections.
This post is aimed at candidates with substantial GCP knowledge and experience.
The recruitment process consists of an application form, interview and an assessment centre aimed at evaluating your experience and knowledge of GCP as well as your technical abilities and behaviours which will help you succeed in this role.
Further information on our training and accreditation process to become an inspector will be provided during the various stages of recruitment.
Key Responsibilities
- To perform GCP inspections of sponsors, CROs, Phase I units, contracted trial vendors and investigator sites, primarily within the UK but also overseas. This includes planning, conducting and reporting inspections and assessing the adequacy of responses from the inspected organisation.
- To provide advice and engage effectively with external stakeholders across a variety of platforms.
- To work closely across inspection teams, Agency departments and external regulators to ensure inspection activities are communicated effectively.
- To support the continued development of the Compliance Team quality system by maintaining current knowledge and expertise in relevant scientific, professional and administrative matters.
Person specification
- A degree in a relevant science, medical or engineering degree (e.g. pharmacy, chemistry, microbiology, pharmacology, biochemistry, biology, medicine, engineering).
- Extensive experience of working in a Good Clinical Practice orientated regulatory environment, for example in a pharmaceutical, healthcare or research institution
- Ability to work unsupervised for long periods of time, but also able to work within a team environment demonstrating good planning and organisational skills to meet tight deadlines and manage multiple priorities.
- Proven ability to analyse and identify issues, make sound decisions, take appropriate actions tactfully and effectively, influence key stakeholders and take responsibility for results.
- Excellent verbal and written communication skills.
- IT literate including skills in Microsoft Office.
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
Benefits
- 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
Things you need to know
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.
- Numerical and verbal reasoning test, further information will be supplied when you reach this stage, if you are successful you will then progress to the next stage.
- The interview, will include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles
- Assessment Centre
This will consist of a variety of activities carried so we can get to know a little more about you and your experience. Activities at the assessment centre may include a technical interview, production of a written report, data analysis exercise and a presentation.
There will also be opportunities to discover more about the role, working for the MHRA directly from inspectors and to ask any questions you may have.
- In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of extensive experience of working in a Good Clinical Practice orientated regulatory environment, for example in a pharmaceutical, healthcare or research institution
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 to complete the form. 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.
If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.
Closing date: 1st October 2024
Shortlisting date: from 2nd October 2024
Interview date: week commencing 14th October 2024
Assessment Centre: week commencing 4th November 2024
Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.
If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.
Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.
Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.
Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.
Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.
In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@mhra.gov.uk.
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
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Job contact :
- Name : The Resourcing Team
- Email : careers@mhra.gov.uk
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- Email : Careers@mhra.gov.uk
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