Head of Medicines Assessment Team (Innovative or Established Medicines Licensing)

Job summary

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s sovereign regulator for medicines, including biological medicines, medical devices, and blood products. Our primary purpose is to ensure that products intended for the UK market are safe and effective and to monitor the ongoing safety of licensed products.

We are currently looking for a 2 x Head of Medicine (Innovative or Established Medicines) to join our Healthcare Quality and Access Group.

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 to enable licensing and market access, as well as ensuring compliance with regulations and standards.

The Innovative Medicines function delivers a risk appropriate critical appraisal of quality, safety and efficacy of innovative medicinal products, determining whether a product’s benefits outweighs the risks. It aims to accelerate their route to market to drive earlier patient access. Through this function the Agency will be seen as a leader in facilitating early access to safe and innovative medicines attracting the life sciences sector and contributing to a positive patient experience and to the improvement of public health outcomes.

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.

Job description

Role Purpose

The post holder is part of the Innovative Medicines and Established Medicines senior leadership team. The post holder will provide operational management support for one of the medicine assessment teams that evaluate marketing authorisation applications and variation applications for chemical new active substances and established medicines. The post holder’s team will assess applications via national or international recognition routes across one or more therapeutic areas. The post holder will provide guidance and direction to the team to drive a targeted and risk proportionate evaluation of benefits and risks in the context of the UK healthcare system.

In addition to managing a medicines assessment team, the post holder may be asked to manage at least one specialist team which supports the function of Innovative Medicines and Established Medicines. The post holder will support matrix working across the Innovative Medicines, Established Medicines and Authorisation Lifecycle areas of HQA as necessary.

Key Responsibilities

• Provide leadership and management to the medicines assessment team (and potentially specialist teams), including the training and development of individual staff and the team, managing their performance.

• Contribute to the wider management of the Innovative Medicines and Established Medicines function, motivating and developing teams to ensure delivery of targets and objectives focussed on patients and public.

• Ensure the quality of assessment decisions made across the team to protect public health.

• Maintain oversight of all scientific and regulatory issues relating to medicines evaluation ensuring the smooth operation of procedural and business processes associated with authorisation of medicines.

• Manage workload and allocation within the team, working in conjunction with other teams in the Innovative Medicine, Established Medicines and Authorisation Lifecycle areas as needed.

• Contribute to Agency policy, engage with stakeholders and respond to issues and requests that arise.

• Collaborate with other Agency employees and stakeholders to manage projects and implement changes to legislation, information processing and work systems as necessary.

In addition, the post holder will be required to:

• Create a sense of purpose for colleagues through highlighting connections between our work and the impact on patients and the public, inspiring colleagues to be fully engaged in their work.

• Deliver difficult or complex messages with decisiveness, clarity and sensitivity, being persuasive when required.

• Promote diversity, inclusion and equality of opportunity, respecting difference and external experience.

• Ensure team members are accountable: empowered to make decisions, innovate and challenge without being blamed.

• Be self-aware and role-model continuous self-learning and development.

The job description is not intended to be exhaustive, and it is likely that duties may be altered from time to time in the light of changing circumstances and after consultation with the postholder.

Person specification

Essential Criteria

• Significant relevant experience in one or more of regulatory assessments, regulatory affairs or development of medicinal products for marketing applications, either within the pharmaceutical industry or medicines regulation.

• Degree in pharmacy, medicine or other relevant science discipline.

• Detailed knowledge regarding the development or authorisation of new medicinal products and variations, including knowledge of relevant guidelines

• Knowledge of relevant national legislation and procedures applicable to the licensing of human medicinal products.

• Keen attention to detail with proven ability to apply critical thinking to complex problems for patient benefit.

• Experience in leadership and effective line management with excellent interpersonal communication skills.

Qualifications

Degree in pharmacy, medicine or other relevant science discipline.

Behaviours

We'll assess you against these behaviours during the selection process:

• Delivering at Pace
• Communicating and Influencing
• Leadership
• Working Together

Benefits

Alongside your salary of £86,000, Medicines and Healthcare Products Regulatory Agency contributes £24,914 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• Learning and development tailored to your role
• An environment with flexible working options
• A culture encouraging inclusion and diversity
• A Civil Service pension with an employer contribution of 28.97%

**Please refer to the candidate pack to ensure you review our full list of very extensive benefits available**

Things you need to know

Artificial intelligence

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 (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours and Experience.

Please provide a 2 page Anonymised CV which sets out your career history, previous experience and skills, highlighting specific responsibilities that are relevant for this role.

We have also included a pre-sift question to complete. Should we receive a high number of applications we will use this as our pre sift criteria. The question must be answered and will appear on the portal as follows; Candidates who do not provide a CV and sufficient answer to the pre sift question will not be invited to interview.

Pre-sift question: In no more than 300 words describe the extent of your experience in regulatory assessments, regulatory affairs or development of medicinal products for marketing authorisation applications and why this experience is relevant to the role.

We are only able to offer feedback at interview stage.

Those invited to interview will receive a presentation topic to be prepared ahead of the day to begin the interview. No more than 5 minutes before questions.

Feedback will only be provided if you attend an interview or assessment.This role has a minimum assignment duration of 3 years. An assignment duration is the period of time a Senior Civil Servant is expected to remain in the same post to enable them to deliver on the agreed key business outcomes. The assignment duration also supports your career through building your depth of expertise.

As part of accepting this role you will be agreeing to the expected assignment duration set out above. This will not result in a contractual change to your terms and conditions. Please note this is an expectation only, it is not something which is written into your terms and conditions or indeed which the employing organisation or you are bound by. It will depend on your personal circumstances at a particular time and business needs, for example, would not preclude any absence like family friendly leave. It is nonetheless an important expectation, which is why we ask you to confirm you agree to the assignment duration set out above.

Security

Successful candidates must undergo a basic (or equivalent) criminal record check.Successful candidates must meet the security requirements before they can be appointed. The level of security needed is security check (opens in a new window).

See our vetting charter (opens in a new window).People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• 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 theCivil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information

This vacancy is part of the Great Place to Work for Veterans (opens in a new window) initiative.Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : The Resourcing Team
• Email : careers@mhra.gov.uk

Recruitment team

• Email : Careers@mhra.gov.uk

Further information

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 contact the Resourcing team at Careers@mhra.gov.uk, in the first instance. 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 SW1A 2HQ

Attachments

Final SCS1 Candidate Pack - Head of Medical Assessments (Innovate & Established medicines licensing) FINAL PDF Opens in new window (pdf, 670kB)