Description
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 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.
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.
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.
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.
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.
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