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About the Role

The role encompasses a broad range of activities from assessing clinical aspects of clinical trial authorization (CTA) applications and amendments to existing CTAs, to providing scientific advice to companies around clinical/regulatory issues for the development of new products. The role holder will be expected to contribute to policy and strategy development to maintain and enhance the reputation of the UK as a great place to conduct clinical research, identifying synergies and opportunities for streamlining across the functional areas of the Science, Research and Innovation Group. The role is both intellectually challenging and rewarding and provides significant opportunity for scientific and regulatory learning.

Responsibilities

Carry out the risk-based assessment of data provided in clinical trial authorisation initial and amendment applications for chemical, biological or advanced therapy products making appropriate recommendations and decisions in line with the protection of public health.
Prepare and present objective assessment reports or other scientific papers to expert advisory bodies.
Manage own workload working in conjunction with the support team and other assessors to meet agency deadlines.
Provide scientific and clinical trial expertise in advice meetings with external stakeholders, obtaining cross-agency or external support depending on the questions posed.
Provide a written response to enquiries submitted through a variety of sources, including via internal customer-facing portals and the wider civil service.
Contribute where medical input is required in critical clinical trial projects and contribute to the Innovative Licensing and Access Pathway (ILAP).

Requirements

Substantial proven experience working as a medical assessor in the assessment of Clinical Trial Authorisation (CTA) applications, making independent decisions on their suitability for approval within regulatory timelines, as well as experience providing scientific or regulatory advice.
Demonstrate a consistently high level of performance in the role including a high throughput of work commensurate with experience and knowledge to meet required deadlines.
Degree in Medicine, registered with the General Medical Council, with a relevant postgraduate qualification and/or experience.
Previous experience of the assessment of clinical aspects of a clinical trial authorisation or marketing authorisation application.
Up to date knowledge of relevant legislation and procedures applicable to the regulation of clinical trials.

Skills

Communicating and Influencing
Managing a Quality Service
Delivering at Pace
Making Effective Decisions

Location

10 South Colonnade, Canary Wharf London, E14 4PU

Work Type

Full-time
Permanent
Hybrid

Experience Level

Substantial proven experience

Education Level

Degree in Medicine
Registered with the General Medical Council
Relevant postgraduate qualification and/or experience

About the Company

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 Innovation and Compliance Group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability.
It is divided into 3 sub-Groups, Innovation Accelerator and Regulatory Science, Clinical Investigations and Trials and Standards and Compliance.
The clinical investigations and trials function ensure the efficient, pragmatic, proportionate and patient-centred advice for, and assessment of, clinical investigations into the performance and safety of medical devices and diagnostics as well clinical trials of investigational medicinal products.

Equal Opportunity

Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules.
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.
Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements.
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.