Head Product Information Quality Unit - £73,324 p.a. + benefits

We are currently looking for a Head of PIQ to join our Authorisation Lifecycle Function within the Health 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 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 Authorisation Lifecycle (AL) function is an enabler, central to delivery of the frontline HQA group. It includes data assurance and quality, high-volume certification work, the operation of a notification scheme for e-cigarettes and coordination and support to the frontline functions. It also includes more complex activity that supports across the product lifecycle such as medicines and medical devices borderline, patient information, and medicines advertising.
The Product Information Quality Unit (PIQU) is the centre of excellence responsible for the assessment of labels and leaflets for medicines, undertaking direct assessment and advising the MHRA to promote the safe use of medicines in the UK., The post holder is responsible for leading and managing a team circa 3 full time employees. The team acts as a centre of excellence for the assessment of labels and leaflets accompanying licensed medicinal products, taking account of the needs of patients and healthcare professional. They will have strategic oversight of handling the work of the team as well as providing specialist advice on patient information, as required across the Agency.
The post holder will lead for the Agency on product information policy and guidance development including development of electronic Patient Information strategies, maintaining effective working relationships with appropriate trade associations, such as APBI, BGMA, PAGB and other regulators.
This is an important and central supporting role requiring management and leadership of a team responsible for service delivery and support functions to internal and external stakeholders and to ensure regulatory compliance by external stakeholders., + Lead, develop and manage the PIQU team to maintain quality of regulatory decisions and adherence to targets and assessment deadlines.
+ Ensure that all HQA staff who assess labels and leaflets for medicines have adequate training and providing specialist advice on patient information, as required across the Agency, to ensure that high quality information is consistently provided to patients with their medicines.
+ Manage and implement targeted reviews of patient information which arise from complaints or reports of medication errors, with input from medical, scientific and other staff as required, and to negotiate improvements with the pharmaceutical companies or, if necessary, take regulatory action consulting the Commission on Human Medicines as needed.
+ Represent MHRA with external bodies e.g., other regulators, Trade Associations, Industry representative groups, external stakeholders on regulatory and regulatory and product information policy., 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.
+ Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
+ 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., + UK nationals
+ nationals of the Republic of Ireland
+ nationals of Commonwealth countries who have the right to work in the UK
+ 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)
+ 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)
+ individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
+ 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).

+ The successful candidate will have In-depth knowledge of the legal requirements for medicines packaging and labelling and the range of design-for-safety options that may be used.
+ You will have demonstrable leadership skills with significant experience of managing operational delivery to internal and external stakeholders within a team environment.
+ You will be able to demonstrate the ability to be flexible and focused and have the determination to drive service delivery and projects to achieve successful outcomes.
+ You will be able to provide insight into complex, novel, sensitive or evolving issues with wide-ranging consequences.
+ You will have excellent influencing skills, managing both internal and external stakeholders to ensure decisions are in line with the protection of public health in respect of patient information., 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 £73,324, Medicines and Healthcare Products Regulatory Agency contributes £21,241 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
+ 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