Details Reference number 347899 Salary £56,353 A Civil Service Pension with an average employer contribution of 27% GBP Job grade Grade 7 Contract type Permanent Business area MHRA - Healthcare, Quality and Access Group Type of role Science Working pattern Full-time, Job share, Part-time Number of jobs available 6 Contents Location About the job Benefits Things you need to know Apply and further information Location London About the job Job summary Are you passionate about making a real impact on public health? Do you possess a keen eye for detail and an analytical mindset? If so, we have the perfect opportunity for you We are expanding our Healthcare Quality and Access group and are looking for talented and diligent individuals to join us as Pharmaceutical Assessors in our Established Medicines Team. Who are we and how will I be contributing to Public Health? The Medicines and Healthcare products Regulatory Agency (MHRA) 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. Pharmaceutical Assessors in the Established Medicines team, work within our Population Health function to assess the quality aspects (including bioequivalence, when needed) of both initial and variation marketing authorisation for medicinal products. The function aims to enable wider access to important medicines as alternative or complimentary to innovative medicines, reduce costs to the healthcare system, and deliver positive patient benefits. The Population Health function is part of our Healthcare Quality and Access Group (HQA), which aims to bring 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. This enables us to drive quality and critically appraise the benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. This is a full-time opportunity, on a permanent basis. Flexible working arrangements such as part-time/job sharing may be available. Please discuss this with the recruiting manager before accepting an appointment. 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 practice a flexible, hybrid way of working, with a minimum of 40% of contractual hours 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 60%, with the remainder of time worked either remotely or in the office Some roles will need to be on site more regularly. Reporting to one of the Heads of Team in Population Health, Pharmaceutical Assessors assess the quality aspects (including bioequivalence, when needed) of both initial and variation marketing authorisation applications for chemical medicinal products and take decisions on their suitability for approval. The role may also involve assessment of complementary therapies, including homeopathic and traditional herbal medicinal products. The role encompasses a broad range of activities from assessing an application for a new active substance, a novel dosage form, or a generic medicine, to providing scientific advice to companies around pharmaceutical/regulatory issues for development of new drug products. A comprehensive training programme is in place to support and develop suitable candidates new to this role. Person specification Successful candidates will have knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products and have an in-depth and up to date specialist level of knowledge in one or more relevant scientific arears or broader knowledge across the range of scientific activities relating to pharmaceutical development, manufacture, and quality control of medicinal products. Successful candidates will have in depth experience gained within the pharmaceutical industry, hospital pharmacy or academia in at least one of the following areas: regulatory affairs; research development; manufacture or quality control. Successful candidates will use their knowledge and skillsets to carry out assessments for marketing authorisation applicants for chemical products, making appropriate recommendations and decisions in line with the protection of public health. They will contribute to assessment policy and practice, provide scientific advice to companies around pharmaceutical/regulatory issues, and prepare and present assessments and other scientific papers to expert advisory bodies. A comprehensive training programme is in place to support and develop suitable candidates new to this role. 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 careersmhra.gov.uk Benefits Alongside your salary of £56,353, Medicines and Healthcare Products Regulatory Agency contributes £15,215 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides. 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. We will hold webinars throughout the course of this recruitment campaign to talk through the Success Profiles and to provide some additional information on the Pharmaceutical Assessor role. If you would like to attend a webinar, please express your interest here. Online application form, which will include three questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure your answers are supported with examples to evidence your experience. Applications may not be considered if any parts of the application form are left blank. 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 Candidates must upload their CVs. Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored against the person specification criteria as set out in the job description, ensure you have read these thoroughly and allow sufficient time. You can view the criteria for this role in the job description. Applicants must ensure that anything submitted must be 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 careersmhra.gov.uk as soon as possible. Closing date: This is a rolling recruitment campaign; a minimum of two weeks notice will be provided before closing. Interview date: Interviews will take place throughout the year. Candidates will be given 5 working days notice of the interview date. If you need assistance applying for this role or have any other questions, please contact careersmhra.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