Expert Pharmaceutical Assessor (CDF) in London

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 Group 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 Established Medicines function within the Healthcare Quality and Access group delivers a risk appropriate critical appraisal of quality, safety and efficacy of healthcare products that are vital to the NHS and wider population, determining whether a product’s benefits outweigh the risks. This includes our work on established medicines, complementary medicines, self-medication, parallel imports, and unlicensed imports. This enables access whilst ultimately reducing costs to the healthcare system and delivering positive patient benefits as a result.

Reporting to the Team or function Manager, Expert Assessors are required to assess the quality related aspects of product licensing, initial and variation applications including those with new or very complex issues with wide-reaching implications. Expert Assessors will also make a high profile, long term or strategic contribution to the Function and Agency through their wider activities.

• Assessment of Product Licensing Submissions
• Sharing Knowledge and Development of Self and Colleagues
• Contribution to Policy and Procedures
• Communication with Stakeholders

Our successful candidate will demonstrate the following:

• Experience of working as a senior or lead-senior pharmaceutical assessor having demonstrated a consistently high level of performance in that role and proven ability to handle a varied and challenging workload with high throughput commensurate with experience and knowledge to meet required timelines.
• Proven ability to evaluate and provide insight into the most complex, novel, sensitive or evolving issues with wide-ranging consequences, under pressure, using evidence or taking input from a variety of sources to make sound recommendations or decisions in line with the protection of public health.
• Recognised by peers and stakeholders outside the Agency as having an expert level of knowledge and leading opinion in one or more relevant therapeutic or scientific areas which is shared to the benefit of the division.
• Highly developed written and verbal communication skills used in a range of circumstances and appropriate to the target audience to proactively influence internal and external issues and disseminate information internally and externally as appropriate.
• Detailed working knowledge and experience of national and European regulations and procedures applicable to the relevant area and evidence of being able to work within the wider governmental or international environment to achieve successful outcomes.

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation

• Working Together (A)
• Communicating and influencing (A, I)
• Delivering at Pace (A)

• Experience of working as a senior or lead-senior pharmaceutical assessor having demonstrated a consistently high level of performance in that role and proven ability to handle a varied and challenging workload with high throughput commensurate with experience and knowledge to meet required timelines. (A, I)
• Proven ability to evaluate and provide insight into the most complex, novel, sensitive or evolving issues with wide-ranging consequences, under pressure, using evidence or taking input from a variety of sources to make sound recommendations or decisions in line with the protection of public health. (A, I)
• Recognised by peers and those outside the Agency as having an expert level of knowledge and leading opinion in one or more relevant therapeutic or scientific areas which is shared to the benefit of the division (A, I)
• Evidence of being able to effectively use knowledge and skills to develop others for example by coaching and mentoring, advising colleagues in own area of specialisation, constructively reviewing the work of others and in presentations (I)

• Honours Degree in a relevant specialist subject. (A)
• Detailed working knowledge and experience of national and European regulations and procedures applicable to the relevant area and evidence of being able to work within the wider governmental/public bodies or international environment to achieve successful outcomes. (I)
• IT skills appropriate for an information-based organisation and a fast-paced working environment. (A, I)

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

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The selection process: 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.

Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of candidates having experience of working as a senior or lead-senior pharmaceutical assessor having demonstrated a consistently high level of performance in that role and proven ability to handle a varied and challenging workload with high throughput commensurate with experience and knowledge to meet required timelines.

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.

Eligible applicants should discuss their intention/application and supporting statement with their line manager. Following the discussion, the line manager and countersigning manager must complete the Managers Endorsement Form (Word), which is then submitted by the internal applicant on as an attachment document. It is recommended that you allow your line manager at least three working days to complete this to ensure your application can be submitted on time.

To apply, please submit an application via the Oracle Recruit system and attach the following documents: CV Supporting statement detailing how you meet the criteria marked with an ‘A’ on the person specification Managers endorsement form.

Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance for more information on appropriate and inappropriate use.

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

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. Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens
• Maintenance roles, particularly those required to work in laboratory settings
• Roles that involve visiting other establishments where vaccination is required
• Roles required to travel overseas where specific vaccination may be required.

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.

Standard Cabinet Office rules on pay will apply to civil servants appointed on level transfer or promotion. Their salary will increase to the minimum of the SCS PB1 range or by a promotion award of up to 10% more than their current basic salary excluding all allowances (whichever is the greater). Individuals appointed on level transfer will retain their existing basic salary excluding all allowances. You may be eligible for a non-consolidated annual bonus payment, subject to successful performance, in line with the Senior Civil Service pay arrangements. These are set annually within the guidelines laid down by the Cabinet Office.

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 careers@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 info@csc.gov.uk Civil Service Commission Room G/8 1 Horse Guards Road London