Job summary
We are currently looking for aGood Clinical Practice Inspectorto join ourStandards and ComplianceFunction within theHealthcare Quality and Access group.
This is afull-timeopportunity, on apermanentbasis. 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 ( 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,
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Benefits
Alongside your salary of �52,603, Medicines and Healthcare Products Regulatory Agency contributes �15,239 towards you being a member of the Civil Service Defined Benefit Pension scheme. 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 ServiceCivil Service Pension Scheme.� Please see the link for further information For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on �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�
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