Skip to main content

This job has expired

UK-KXS Clinical Regulatory Affairs Manager

Employer
Global Academy Jobs
Location
United Kingdom
Closing date
Jul 17, 2018

View more

Job Details

Job Purpose

A major goal of the Life Sciences Industrial Strategy is to establish the UK as a global hub for clinical research and medical innovation, through novel and efficient partnerships between industry, the NHS, academia, charities and research funders. Critical to achieving this ambition is improved Knowledge Exchange (KE), which has to date suffered from limited bi-directional (or even unidirectional) flow of information; intra-sectoral competition; and a lack of clarity on mechanisms for multi-disciplinary approaches and shared rewards. To address this challenge, HEFCE’s Connecting Capability Fund (CCF) is supporting the establishment of a national network of collaborators to consolidate UK capabilities and accelerate impact by pooling the expertise, resources, and infrastructures of 3 HEIs (Universities of Oxford, Birmingham and Dundee) – the UK Knowledge Exchange Spine (UK-KXS).

Within this wider framework, we have chosen an exemplar project for collaboration. One of the biggest healthcare challenges facing the UK and indeed the world is to improve therapeutics for the elderly and to reduce the impact of many age-related comorbidities. We have initiated a national network of collaborators, linking the core HEI partners with the Medicines Discovery Catapult and The Francis Crick Institute. Together we will create the tools, ideas/ knowledge, and pathways for developing new therapeutics for diseases linked with ageing, help industry exploit them, work with investors to create new companies and associated jobs, and embrace the NHS as co-creators as well as adopters of innovation. This ambitious project will provide core proof of principle and insight aligned to our wider HEFCE CCF framework of KE and open innovation between not only the core partners but the wider UK academic, clinical, charitable and industry landscape.

The role of the Clinical Regulatory Affairs Manager needs to support the UK-KXS partners by bringing Regulatory Affairs experience and insights into the partnership, fostering cross-sector discussions and dissemination of knowledge. They will act as the go-between for the UK-KXS partners and will consult with various regulatory bodies on behalf of UK-KXS as well as cross-sector stakeholders in industry, the NHS and academia. They will need to build up an awareness of new mechanisms, targets and mechanism underpinning the process of ageing to work with the appropriate regulatory bodies to develop an understanding of the developmental mechanisms underpinning new therapeutics which will then meet all the necessary regulations. This will include supporting the coordination, preparation and submission of dossiers for projects developed through the partnership. The post-holder will be based in Birmingham as part of the College of Medical & Dental Sciences (MDS) Research and Knowledge Transfer Office, and will work closely with the partners of the UK-KXS. The post holder will also be expected to maintain close links with the various stakeholders of the UK-KXS and support appropriately informed interactions between these institutions that are of mutual benefit, positioning it for wider shared learning across the UK Higher Education, NHS and industry landscapes. The post-holder will take a direct role in the oversight and management (where appropriate) of the UK-KXS’s initiatives, and will be responsible for the day-to-day coordination and administration within their field. The post-holder will build significant links to internal and external collaborators, and provide an efficient and effective central point of contact and responsibility. This will involve leading and maintaining up to date communications with various stakeholders, reports, budgetary oversight, databases, leading the organisation and coordination of meetings, dissemination events and leading in the planning of future activities. The post holder will work closely as part of Birmingham Health Partners, which is a strategic alliance between University Hospitals Birmingham NHS Foundation Trust, University of Birmingham and Birmingham Women & Children’s NHS Foundation Trust. This post will be based in the Institute of Translational Medicine in Birmingham. The role will need to work with the various local, regional and national Clinical Trial Units and the Centre for Patient Reported Outcomes Research and liaise on behalf of the UK-KXS with the appropriate sponsors of activity. This includes supporting regulatory authorisations, pharmacovigilance and IMP systems, training, project planning, initiating and management.

The post holder is expected to be knowledgeable and experienced in regulatory compliance, systems for trials and in managing and working at a senior level within academia, the NHS or relevant other sectors

 

Person Specification

The role of the Clinical Regulatory Affairs Manager is to support the partners of the UK Knowledge Exchange Spine (UK-KXS) by bringing Regulatory Affairs experience and insights into the partnership, fostering cross-sector discussions and dissemination of knowledge.

They will act as the go-between for the UK-KXS partners and may need to consult for the partnership with various regulatory bodies as well as cross-sector stakeholders in industry, the NHS and academia. They will need to build up an awareness of new processes, targets and biological mechanisms underpinning the process of ageing to work with the appropriate regulatory bodies to support the development of new therapeutics which will then meet all the necessary regulations. This will include supporting the coordination, preparation and submission of dossiers for projects developed through the partnership.

The post-holder will be based in Birmingham as part of the College of Medical & Dental Sciences (MDS) Research and Knowledge Transfer Office, and will work closely with the partners of the UK-KXS. The post holder will also be expected to maintain close links with the various stakeholders of the UK-KXS and support appropriately informed interactions between these institutions that are of mutual benefit, positioning it for wider shared learning across the UK Higher Education, NHS and industry landscapes.

The post-holder will take a direct role in the oversight and management (where appropriate) of the UK-KXS’s initiatives, and will be responsible for the day-to-day coordination and administration within their field.

The post-holder will build significant links to internal and external collaborators, and provide an efficient and effective central point of contact and responsibility. This will involve leading and maintaining up to date communications with various stakeholders, reports, budgetary oversight, databases, leading the organisation and coordination of meetings, dissemination events and leading in the planning of future activities.

The post holder will work closely as part of Birmingham Health Partners, which is a strategic alliance between University Hospitals Birmingham NHS Foundation Trust, University of Birmingham and Birmingham Women & Children’s NHS Foundation Trust. This post will be based in the Institute of Translational Medicine in Birmingham.

The role will need to work with the various local, regional and national Clinical Trial Units and liaise on behalf of the UK-KXS with the appropriate sponsors of activity. This includes supporting regulatory authorisations, pharmacovigilance and IMP systems, training, project planning, initiating and management.

The post holder is expected to be knowledgeable and experienced in regulatory compliance, systems for trials and in managing and working at a senior level within academia, the NHS or relevant other sectors.

Any other duties which will be consistent with the role.

 

Required Knowledge, Skills, Qualifications, Experience

  • Provide specialist regulatory affairs management advice to investigators and other partner members.
  • Take an active role in the development of new research proposals (including contributing to the design, preparation of grant applications and protocols), negotiate with external regulatory parties and assist in the preparation and review of contracts/agreements in liaison, where appropriate, with the partners of UK-KXS.
  • Work independently but seek appropriate guidance on important or new issues that require policy decision or have serious resource implications, or could impact on the work of other teams or affect the Unit’s external profile.
  • Support development of the UK-KXS’s research portfolio and knowledge dissemination programme.
  • Ensure milestones are met and projects are delivered to time and target.
  • Advise the UK-KXS Senior Management of potential issues which may affect delivery of the trials and advise.
  • Liaise with regulators, funders, external service providers and other third party organisations as appropriate.
  • Write policies, Standard Operating Procedures and quality control documents.
  • Take an active role in training staff.
  • Keep up to date with changes in medical literature and regulatory issues and develop strategies for future direction of study management.
  • Help ensure that new skills, knowledge and best practice are disseminated widely and taken up by the UK-KXS members.
  • Undertake other tasks as applicable to the role and grade of the post.
  • Act as the lead contact with regulatory agencies for UK-KXS projects.
  • Act as a point for advice on recommending strategies for therapeutic projects or scientific activities.
  • May be a representative in due diligence activities.
  • Recommends improvements in methodology and may execute those improvements widely. May identify recurring problems and initiate improvements.

 

Company

Global Academy Jobs works with over 250 universities worldwide to promote academic mobility and international research collaboration. Global problems need international solutions. Our jobs board and emails reach the academics and researchers who can help.

"The globalisation of higher education continues apace, driving in turn the ongoing development of the global knowledge economy, striving for solutions to the world’s problems and educating a next generation of leaders and contributors."

Company info
Website

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert