Job description

Job responsibilities

Strategic Leadership

• Provide overall leadership and strategic direction for the Beyond ADMET: AI for Medicines Safety regulatory sandbox.
• Lead delivery of the programme's strategic priorities, ensuring alignment with the MHRAs strategy and wider government ambitions for AI and life sciences.
• Serve as the senior leader for the programme, ensuring delivery of agreed outcomes, benefits and impact.
• Identify future opportunities for innovation, collaboration and capability development across the AI for Safety portfolio.

Scientific and Technical Leadership

• Act as the senior scientific and technical leader for the programme, ensuring activities are grounded in robust evidence and scientific excellence.
• Provide expert leadership across areas such as artificial intelligence, machine learning, computational modelling, pharmacology, toxicology, healthcare data science, drug development and regulatory science.
• Guide the evaluation of emerging technologies, methodologies, datasets and validation frameworks relevant to regulatory decision-making.
• Ensure programme outputs generate meaningful evidence that can inform future regulatory approaches, guidance and policy.
• Promote innovation while ensuring appropriate standards of quality, transparency, safety and governance.

Programme Oversight and Governance

• Oversee delivery of the programme through effective governance, assurance and performance management arrangements.
• Lead programme boards, steering groups and governance forums.
• Ensure risks, issues, dependencies and opportunities are identified and managed appropriately.
• Oversee programme resources and budgets, ensuring value for money and effective use of public resources.
• Work closely with the Technical Lead, Programme Manager, and Regulation & Policy Lead to ensure effective operational delivery against agreed objectives and milestones.

Stakeholder Engagement and External Leadership

• Build and maintain strong strategic relationships across industry, academia, government, healthcare organisations, patient groups and international regulatory networks.
• Represent the MHRA as a senior spokesperson and thought leader on AI-related regulatory science initiatives.
• Lead engagement with senior external stakeholders to promote collaboration and maximise programme impact.
• Champion dissemination of programme findings, learning and best practice.
• Foster strong connections across the MHRA's wider portfolio of AI initiatives and regulatory sandboxes

People Leadership

• Lead and develop a high-performing multidisciplinary team.
• Create an inclusive culture that encourages innovation, collaboration and continuous improvement.
• Manage senior staff, including technical leadership roles and programme management resource.

Regulatory Science and Organisational Impact

• Support the development of future regulatory policy, guidance and frameworks relating to AI-enabled technologies.
• Identify opportunities to strengthen the MHRAs capability in AI, advanced analytics and regulatory science.
• Contribute to wider MHRA strategic priorities including evidence-based regulatory decision-making and improvements in patient safety.
• Promote the MHRA's reputation as an international leader in innovative regulation.

General

• While the immediate focus of this role is the successful delivery of the Beyond ADMET: AI for Medicines Safety regulatory sandbox, the postholder will be expected to provide leadership and expertise across the Agency's evolving AI, data and regulatory science agenda.
• Champion the MHRA values and Civil Service behaviours, promoting an ethical, positive and inclusive working environment.
• Proactively maintain and develop professional knowledge and expertise, sharing learning and best practice with colleagues.
• Demonstrate flexibility and adaptability in response to emerging technologies, scientific developments and changing business needs.

Person Specification

Technical Criteria

Essential

• Recognised expertise in either:
• Artificial Intelligence, Machine Learning, Data Science or Computational Modelling; or
• Pharmacology, Toxicology, Drug Development, NAMs or related life science disciplines.
• Broad understanding of the wider AI and medicines development ecosystem, with the ability to lead multidisciplinary teams spanning both domains.
• Ability to evaluate scientific evidence and emerging technologies and translate findings into regulatory and strategic recommendations.

Qualifications

Essential

• Degree in a relevant scientific, technical or healthcare discipline (or equivalent experience).
• Postgraduate qualification (MSc, PhD or equivalent experience) in a relevant field such as artificial intelligence, computational biology, pharmacology, toxicology, data science, bioinformatics, pharmaceutical sciences or a related discipline.

Experience

Essential

• Experience leading complex strategic programmes, scientific portfolios or major innovation initiatives, and successful delivery of their outcomes.
• Experience managing multidisciplinary teams and leading highly specialised technical experts.
• Experience influencing senior stakeholders, operating effectively across organisational boundaries and working collaboratively with external partners including academia, industry, government and healthcare organisations.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU

United Kingdom

Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Job description

Job responsibilities

For full details on job description, please refer to advert attached and visit:Advisory Board on the Registration of Homeopathic Products - GOV.UK

To make an application please email your application form, CV, completed monitoring form and declaration of interest form to: [email protected], quoting the position and reference ABRHP26-1 in the subject field.

Please note that applications submitted to [email protected] will be considered only.

Person Specification

Qualifications

Essential

• The Chair must be able to demonstrate the qualities, skills and experience to meet all of the following essential criteria.
• Be medically qualified and have a strong and current scientific background
• Demonstrate an impartial perspective on the use of homeopathy and have an understanding of the importance of regulation of homeopathic medicines.
• Have previous or current experience of high-level committee membership nationally or internationally
• Be a skilled communicator.
• Be able to assimilate complex scientific information at short notice; and provide formal and informal advice to the MHRA between meetings when required.
• Be prepared to relinquish all personal and non-personal interests of a financial nature in the pharmaceutical industry
• Be recognised by their peers as leaders in their field and/or be Fellows of the relevant Royal Colleges.

Desirable

• Knowledge of homeopathy would be an advantage but not essential.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU

United Kingdom

Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Job description

Job responsibilities

Undertake repair, servicing and routine maintenance on medical equipment, to planned schedules / workload and prioritisedtasks, upholding working standards, policies, procedures, and objectives in order to maintain professional standards and servicedelivery.

Communicate with clinical users to gain a clear understanding of the nature of problems with equipment. Assess the seriousness andimplications of the problem and, under advice from senior staff, respond appropriately to the urgency of the user request.

Check that equipment performs to manufacturer's specification.

Carry out safety and acceptance testing on a wide range of medical equipment to an approved protocol.

Undertake first line repairs of medical equipment in accordance with manufacturers instructions.

Use computer skills to maintain relevant scientific and technical records of work performed. In particular ensure the equipmentmanagement computer database (AIMS) is operated in an accurate, methodical manner with work being logged as it progresses untilcompletion.

Extract information from the equipment management database in response to requests by clinical staff or Department management.

Liaise with manufacturers to obtain information on spares availability.

Monitor stocks of appropriate components and spares, requesting where necessary to keep an adequate stock.

Take responsibility for all tools and equipment within the Postholders care. Ensure workshop facilities are kept clear and well-orderedand that all equipment is maintained to acceptable standards.

Inform management and other Clinical Engineering staff of the condition and performance of the equipment within the Postholder'scare.

Respond to Safety Action Bulletins (SABS) from the Medicines and Healthcare products Regulatory Agency (MHRA) and fromequipment manufacturers as directed by the Head of Section.

Participate in regular section meetings.

Be familiar with and follow the Trust's incident report procedure.

We will be unable to accommodate remote interviews for this position - all interview will be face to face

Person Specification

Communication

Essential

• Active listening and verbal communication skills for effective interaction with members of the public and staff at all levels
• Ability to provide information and advice to members of the public and staff in a polite and courteous manner.

Desirable

• Able to communicate information across professional boundaries

Trust Value

Essential

• Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours

Qualifications

Essential

• Relevant NVQ level 2 plus 2 years experience; or equivalent to relevant NVQ level 3

Desirable

• BTEC/ONC in electronics or a scientific subject. Training in repair and maintenance of medical devic

Experience

Essential

• Experience of electrical and / or electronic systems
• nformation Technology experience

Desirable

• Knowledge and operation of a quality management system such as ISO 9001:2000
• nowledge of pneumatic systems

Planning and Organization

Essential

• Capable of working as part of a multi-disciplinary team
• Good organisations skills with the ability to plan and prioritise a demanding workload

EDI

Essential

• Able to demonstrate a commitment to and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual

Others

Essential

• Ability to meet the physical demands required for the role
• Work with members of the clinical engineering team to develop effective maintenance plans Problem solving skills.
• Report concerns related equipment condition to qualified staff.
• Manage time accordingly to ensure tasks are completed to specified timescales

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

University Hospitals of Leicester NHS Trust

Address

Leicester Royal Infirmary

Leicester

LE1 5WW

United Kingdom

Employer's website

https://www.jobsatleicestershospitals.nhs.uk/ (Opens in a new tab)

Job description

Job responsibilities

The post holder shall:

Be a specialist engineer for a range of medical equipment.

Effectively manage the work they are assigned, including the management of more junior staff assigned to the same/similar task, ensuring service objectives and targets are met.

Work under own initiative, manage, and prioritise own workload and workload of others and exercise a broad degree of responsibility.

Play a role in organising, prioritising, and undertaking unsupervised maintenance and repairs to equipment in critical care/surgical areas whilst patients are present.

In consultation with the Section Lead, and Senior Clinical Technologists devise/develop and maintain planned maintenance schedules on all high/medium risk medical equipment.

Undertake preventative maintenance, servicing, inspection, and repair to a wide range of patient-critical medical equipment.

Communicate effectively with clinical users to schedule servicing or gain a clear understanding of the nature of problems with equipment. They shall assess the seriousness and implications of any reported problems and respond appropriately to the urgency of the user request.

Undertake fault-finding. Apply suitable fault-finding techniques to diagnose problems, which may be due to user error, equipment failure or environmental issues (e.g., Temperature, RF interference). Undertake repairs on complex mechanisms and systems to component level

Carry out modifications to highly complex multi-module medical equipment as specified by equipment manufacturers, and any remedial work recommended by the MHRA hazard notices or manufacturer FSNs.

Arrange the return of repaired equipment to the clinical user, taking into account urgency and departmental targets.

Write and update written procedures for the performance and functional verification of medical devices. Assist in ensuring all relevant documentation such as work instructions are complete and up to date.

Take a leadership role in ensuring that stocks of any components and spare parts used, do not fall below agreed levels. Submit requisitions for spare parts, the dispatch of back to base repairs and engineer callouts dealing with subsequent financial queries regarding price verification and delivery of goods and services.

Take a leadership role in developing and maintaining a technical library.

Propose and be prepared to support changes to departmental working practices and to assist the Management team in the preparation of reports and feedback following equipment commissioning, service, repair, evaluation, or failure.

Ensure that work carried out within the service complies with set procedures and conform to the appropriate quality standards. Advise the line manager on any matters of concern to ensure continual improvement of service performance.

Shall have a good knowledge of the trusts policy on Medical Device Management and shall hence bring to the attention of the management team all matters relating to noncompliance of the policy, that they are made aware of.

Prioritise planned preventative maintenance and medical equipment breakdown requests with departmental colleagues to ensure that the overall maintenance plan is achieved, and repairs are made as quickly and as efficiently as possible, keeping in mind the departments defined KPIs.

Keep relevant scientific and technical records of work performed. In particular ensure the equipment management computer database is operated in an accurate, methodical manner with work being logged as it progresses until completion.

Liaise with manufacturers to obtain information on spares availability and return of equipment from repair, or if technical support/advice is required.

Assist with medical equipment procurement exercises by liaising with clinical staff, company representatives and engineers, either during clinical trials or technical evaluations.

Support the calibration organiser to maintain test equipment in a safe and operable condition.

Provide specialised in depth, detailed technical advice regarding the operation, limitations, configuration, procurement, and maintenance aspects of medical equipment to clinical and other staff groups as appropriate. Provide technical support to patients and carers as appropriate. Promote a culture of good customer communications.

Respond to Medical Device Alerts from the Medicines and Healthcare products Regulatory Agency (MHRA) and from equipment manufacturers and as directed by the Section Leads or Clinical Scientists.

Investigate incidents/non-conformances and contribute to high quality technical reports stating the outcomes of findings. Supply information to the management team whom will coordinate responses to risk management and external bodies (MHRA).

Attend and contribute to the regular section meetings. Appreciate and influence policymaking and procedural updates. Take part in other formal meetings and working groups as requested by the section leads/clinical scientists

Ensure that our customers receive a high quality, prompt and efficient service at all times and are kept up to date as to the progress of their equipment maintenance repairs and enquiries.

Appraise staff within the team, ensuring that staff they manage have clear objectives and an appropriate personal development plan.

Monitor and oversee trainees on placement and others as requested by section leads/clinical scientists. Provide technical training and supervision to junior staff, and undertake competency assessments in line with the departmental policy on training and competency.

Be a registered clinical technologist, or be working to achieve this registration. Participate in Continued Professional Development.

Ensure the Provision & Use of Work Equipment Regulations 1998 (PUWER 98). Medicines & Healthcare products Regulatory Agency (MHRA), Institute of Physics and Engineering in Medicine (IPEM)

Participate in a service to remote sites where Clinical Engineering provides a maintenance support service.

Clean and decontaminate contaminated equipment. Information must be sought as to the nature of contamination and the associated risks before carrying this action out.

Manage own day-to-day workload and the workload of others with only minimal direction by line manager. Maintain high quality customer services in the absence of senior staff.

Person Specification

Planning and organisation skills

Essential

• Able to prioritise and manage own work
• Must be able to deal with constantly changing workload and priorities
• Good understanding of the principles of inventory management including Record keeping and database maintenance.
• Capable of working as part of a multi-disciplinary team
• Flexible and adaptable to meet the needs of the service.

Training & Qualications

Essential

• Degree in electronic/clinical engineering or equivalent, OR knowledge at equivalent standard gained through relevant experience/training.

Desirable

• Member of Voluntary Register of Clinical Technologists.
• Technical Registration with an engineering institute.

Experience

Essential

• A good knowledge and significant experience of servicing, repairing and calibration of medical equipment

Desirable

• Significant experience of servicing, repairing and calibration of medical equipmen
• Significant experience in the use and operation of a quality management system such as ISO 9001:2000 and ISO 13485:2012
• Specialist training on the maintenance and repair of a range of medical devices. Information Technology experience

Communication and relationship skills

Essential

• Must be able to communicate articulately with colleagues, external agencies and possess good customer care skills
• Be able to maintain effective relationships with colleagues and with associates in other disciplines. Able to teach others and communicate effectively

Analytical and Judgement skills

Essential

• Able to exercise own initiative/Judgement when dealing with issues within own specialist area of competence. Have the ability to logically solve technical problems,
• Use of fine tools for equipment adjustment/soldering and calibration
• Able to deal with occasional distressing circumstances when working in clinical areas (e.g., when visiting wards and theatre's fault finding on patient connected equipment). Excellent interpersonal skills
• IT literate
• Manage time accordingly to ensure tasks are completed to specified timescales

Desirable

• Detailed fault finding to PCB and component level

Other requirements specific to the role

Essential

• Full valid driving licence
• Be willing to learn/attend specialist training courses and have a positive attitude.
• Evidence of ongoing CPD.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

University Hospitals of Leicester NHS Trust

Address

Leicester Royal Infirmary

Leicester

LE1 5WW

United Kingdom

Employer's website

https://www.jobsatleicestershospitals.nhs.uk/ (Opens in a new tab)

Job description

Job responsibilities

Main Duties and ResponsibilitiesThe main responsibilities of the post include the following:

Clinical Services To provide information, advice and guidance on the safe, effective and economical use of medicines and to challenge poor practice. To clinically validate and prescribe (if qualified, competent and registered on the Trust Non-Medical Prescribers register) medicines to ensure patients are safely treated and have access to medicines in hospital and for discharge in a timely manner To maintain appropriate standards of service and safety; to enforce guidelines, policies and procedures to ensure standards are met. To fulfil the requirements of the Code of Ethics and Standards of Good Professional Practice. To optimise medicines management by reconciling drug histories, performing medication reviews, using patients own medicines, counselling and ensuring continuity of care on discharge. To detect, record and report adverse drug reactions to the Medicines and Healthcare Products Regulatory Agency (MHRA) and via Datix as per Trust Policy. To monitor pharmacy interventions and Datix reports to identify training and information needs To identify and implement service improvements To lead and support on the auditing of medicines and prescribing To implement countywide and local prescribing strategies within the Trust. Facilitate the expansion of the tools within EPMA. Support the development and implementations of medicine related guidance, policies and procedures within medicine and urgent care Support the process for new medicines being integrated into the Trust by Formulary submissions. To undertake validation duties in the dispensary. To supervise, check and, if necessary, undertake the supply of medicines. Technical checking is in place; pharmacists make initial validations and have a professional responsibility to decide on the need for their further involvement in the supply process.

Advanced Clinical Pharmacy Role To lead and develop practice and protocols and how these relate to national and other guidance. To optimise medicines through prescribing role operating within areas of competence (where appropriately qualified and authorised via the Trust NMP register). Provide a specialist clinical pharmacy service to the specialist area. To deputise for the Principal Pharmacist, Medicine and Urgent Care and support other Advanced Pharmacists within this division To provide Advice and Guidance for other pharmacists or other healthcare professionals To demonstrate an understanding of relevant pharmacy services priorities and contribute to the implementation of these priorities Develop and submit relevant business cases Requirement to undertake and support in project work To liaise with High Cost Pharmacy team in relation to biologics and the provision of the service To work across organisational boundaries (primary, secondary, community) to improve integration and reduce variation e.g. to work alongside tertiary care centre in the initiation and continuation of biologics; work alongside primary care in their formulary Leads the development and redesign of services and clinical pathways in collaboration with stakeholders, using data, evaluation, feedback, and workforce insight to inform decisions, and works across organisational boundaries to deliver measurable improvements in patient care and outcomes.

Education, Training and Supervision Act as a role model to the pharmacy team, including supporting junior pharmacist to achieve their objectives Attend clinical pharmacy meetings and education/training schemes relevant to post. To take part in formal and informal education of pharmacy staff and other healthcare professionals To be a Designated Supervisor and /or Designated Prescribing Practitioner for pharmacists undertaking their prescribing course and to supervise aspects of foundation year trainee pharmacists training. To be a supervisor on the Clinical Pharmacy Diploma course. To line manage and lead those staff allocated, undertaking appraisals, supervision and identification of training and development of their skills and knowledge. To assist in the induction of staff into the service; to help identify training and development needs. To provide information to patients, parents, and carers on admission and at discharge regarding treatment and medication to optimise patient concordance, particularly if there is a need to overcome language or communication barriers. To maintain up-to-date clinical knowledge in clinical pharmacy and pharmacy practice to ensure a broad base of pharmaceutical knowledge, clinical reasoning and judgement. To take responsibility for own personal CPD by participating in education and training programmes to improve competence and to develop specialist expertise. To obtain/maintain prescribing qualification and support services and ward rounds as appropriate. To help provide the training for Technicians enhanced patient counselling skills and Medicines Management Technician training. Designs, delivers and evaluates education for multi-professional teams, including inhaler technique, guideline updates, and complex case-based learning. Disseminates findings from audit and quality improvement projects at a local level, sharing learning to inform practice and improve patient outcomes; contributes to wider dissemination through presentations or publications where appropriate. Promotes a culture of learning by sharing insights from incidents, best practices, prescribing trends; linking outcomes to audit and research initiatives to drive continuous improvement.

Financial To be responsible for the co-ordinated advice to the Directorate to effectively manage expenditure on medicines, including tariff medicines, excluded medicines, prior approvals, individual funding requests etc. To horizon scan for new medicines likely to be excluded from the tariff and to advise on clinical and budgetary impact. To produce appropriate reports documenting the use and expenditure of medicines to evaluate trends and variations in prescribing in order to develop and implement policies aimed at containing expenditure and realising savings. To identify and manage medicine/pharmacy Quality/Innovation/Productivity/Prevention (QIPP) Schemes, including Cost Improvement Programme (CIP) Schemes within the Directorate to ensure this is coordinated within the Pharmacy and Trust. To be an authorised signatory for Pharmacy to commit expenditure via the Trusts Standing Financial Instructions and delegated ordering system. To provide expert professional advice on high cost and excluded medicines to clinicians, managers, finance and commissioners

Audit and Research To monitor the use of FP10(HNCs) by the Directorate to ensure the best use of resources in the Emergency Department. To develop, undertake and initiate clinical audit and practice research, drug use reviews, new drug evaluations to improve the quality of the Pharmacy Services. To guide and support others undertaking research audit and service improvements e.g., Trainee Pharmacists or Diploma Pharmacists. To record, monitor and evaluate the effectiveness of pharmaceutical interventions and contributions to ward rounds and Directorate. To analyse and undertake root cause analysis of medication incidents

Other Duties To undertake duties elsewhere in the locality, if required. To undertake on call duties To provide a pharmacy service at weekends

Person Specification

Education, Training and Qualifications

Essential

• Pharmacy Degree, MPharm or BPharm
• Independent prescribing or willing to work towards Independent Prescribing qualification
• Registered with General Pharmaceutical Council
• Diploma in Clinical Pharmacy or equivalent
• Mandatory CPD Portfolio

Desirable

• MSc in Clinical Pharmacy
• Member of Royal College of Pharmacy
• Formal Management training
• Diploma Tutor accreditation

Knowledge and Experience

Essential

• Extensive operational experience at a Senior Hospital Pharmacist level, demonstrating a high degree of autonomy
• Experience of supporting Divisional Pharmacist or equivalent, to include financial expenditure reporting, formulary application, guideline writing
• Experience with working as part of a multidisciplinary team
• Teaching, supervising and training staff

Desirable

• Experience of practice research or audits

Skills

Essential

• Demonstrates a level of clinical reasoning, problem solving and judgement
• IT skills with Word, Excel
• Ability to work independently and as a member of a multidisciplinary team

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Northampton General Hospital

Address

University Hospitals of Northamptonshire

Northamptonshire

Northampton

NN1 5BD

United Kingdom

Employer's website

https://www.northamptongeneral.nhs.uk/Home.aspx (Opens in a new tab)

Job description

Job responsibilities

For a more detailed job description and main responsibilities, please refer to the Band 4 and Band 5 job descriptions as attached.

Person Specification

Knowledge and Experience

Essential

• Previous clinical trial co-ordination related exposure
• Familiarity and/or previous experience of medical terminology

Desirable

• Previous NHS administration experience in oncology and/or haematology
• Previous research experience

Skills and Abilities

Essential

• Good (standard) keyboard skills
• Ability to use Microsoft office suite (Word, Excel, PowerPoint, Outlook, Access, SharePoint)

Desirable

• Ability to handle pipettes/sample handling

Qualifications and Training

Essential

• Good standard of general education e.g. Maths and English
• Degree or similar health related qualification or equivalent range of experience within the role

Desirable

• Current GCP certificate

Aptitudes

Essential

• Ability to work calmly and effectively under pressure
• Ability to communicate effectively and deal tactfully with people
• Excellent organisational skills
• Use initiative and be innovative within the scope of the role
• To be able to prioritise workload
• Excellent accuracy and attention to detail
• Ability to work within a team

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Bristol NHS Foundation Trust

Address

Bristol Haematology and Oncology Centre

Horfield Road

Bristol

BS2 8ED

United Kingdom

Employer's website

https://www.uhbw.nhs.uk/ (Opens in a new tab)

Job description

Job responsibilities

Main Duties and ResponsibilitiesThe main responsibilities of the post include the following:

Clinical Services To provide information, advice and guidance on the safe, effective and economical use of medicines and to challenge poor practice. To clinically validate and prescribe (if qualified, competent and registered on the Trust Non-Medical Prescribers register) medicines to ensure patients are safely treated and have access to medicines in hospital and for discharge in a timely manner To maintain appropriate standards of service and safety; to enforce guidelines, policies and procedures to ensure standards are met. To fulfil the requirements of the Code of Ethics and Standards of Good Professional Practice. To optimise medicines management by reconciling drug histories, performing medication reviews, using patients own medicines, counselling and ensuring continuity of care on discharge. To detect, record and report adverse drug reactions to the Medicines and Healthcare Products Regulatory Agency (MHRA) and via Datix as per Trust Policy. To monitor pharmacy interventions and Datix reports to identify training and information needs To identify and implement service improvements To lead and support on the auditing of medicines and prescribing To implement countywide and local prescribing strategies within the Trust. Facilitate the expansion of the tools within EPMA. Support the development and implementations of medicine related guidance, policies and procedures within medicine and urgent care Support the process for new medicines being integrated into the Trust by Formulary submissions. To undertake validation duties in the dispensary. To supervise, check and, if necessary, undertake the supply of medicines. Technical checking is in place; pharmacists make initial validations and have a professional responsibility to decide on the need for their further involvement in the supply process.

Advanced Clinical Pharmacy Role To lead and develop practice and protocols and how these relate to national and other guidance. To optimise medicines through prescribing role operating within areas of competence (where appropriately qualified and authorised via the Trust NMP register). Provide a specialist clinical pharmacy service to the specialist area. To deputise for the Principal Pharmacist, Medicine and Urgent Care and support other Advanced Pharmacists within this division To provide Advice and Guidance for other pharmacists or other healthcare professionals To demonstrate an understanding of relevant pharmacy services priorities and contribute to the implementation of these priorities Develop and submit relevant business cases Requirement to undertake and support in project work To liaise with High Cost Pharmacy team in relation to biologics and the provision of the service To work across organisational boundaries (primary, secondary, community) to improve integration and reduce variation e.g. to work alongside tertiary care centre in the initiation and continuation of biologics; work alongside primary care in their formulary Leads the development and redesign of services and clinical pathways in collaboration with stakeholders, using data, evaluation, feedback, and workforce insight to inform decisions, and works across organisational boundaries to deliver measurable improvements in patient care and outcomes.

Education, Training and Supervision Act as a role model to the pharmacy team, including supporting junior pharmacist to achieve their objectives Attend clinical pharmacy meetings and education/training schemes relevant to post. To take part in formal and informal education of pharmacy staff and other healthcare professionals To be a Designated Supervisor and /or Designated Prescribing Practitioner for pharmacists undertaking their prescribing course and to supervise aspects of foundation year trainee pharmacists training. To be a supervisor on the Clinical Pharmacy Diploma course. To line manage and lead those staff allocated, undertaking appraisals, supervision and identification of training and development of their skills and knowledge. To assist in the induction of staff into the service; to help identify training and development needs. To provide information to patients, parents, and carers on admission and at discharge regarding treatment and medication to optimise patient concordance, particularly if there is a need to overcome language or communication barriers. To maintain up-to-date clinical knowledge in clinical pharmacy and pharmacy practice to ensure a broad base of pharmaceutical knowledge, clinical reasoning and judgement. To take responsibility for own personal CPD by participating in education and training programmes to improve competence and to develop specialist expertise. To obtain/maintain prescribing qualification and support services and ward rounds as appropriate. To help provide the training for Technicians enhanced patient counselling skills and Medicines Management Technician training. Designs, delivers and evaluates education for multi-professional teams, including inhaler technique, guideline updates, and complex case-based learning. Disseminates findings from audit and quality improvement projects at a local level, sharing learning to inform practice and improve patient outcomes; contributes to wider dissemination through presentations or publications where appropriate. Promotes a culture of learning by sharing insights from incidents, best practices, prescribing trends; linking outcomes to audit and research initiatives to drive continuous improvement.

Financial To be responsible for the co-ordinated advice to the Directorate to effectively manage expenditure on medicines, including tariff medicines, excluded medicines, prior approvals, individual funding requests etc. To horizon scan for new medicines likely to be excluded from the tariff and to advise on clinical and budgetary impact. To produce appropriate reports documenting the use and expenditure of medicines to evaluate trends and variations in prescribing in order to develop and implement policies aimed at containing expenditure and realising savings. To identify and manage medicine/pharmacy Quality/Innovation/Productivity/Prevention (QIPP) Schemes, including Cost Improvement Programme (CIP) Schemes within the Directorate to ensure this is coordinated within the Pharmacy and Trust. To be an authorised signatory for Pharmacy to commit expenditure via the Trusts Standing Financial Instructions and delegated ordering system. To provide expert professional advice on high cost and excluded medicines to clinicians, managers, finance and commissioners

Audit and Research To monitor the use of FP10(HNCs) by the Directorate to ensure the best use of resources in the Emergency Department. To develop, undertake and initiate clinical audit and practice research, drug use reviews, new drug evaluations to improve the quality of the Pharmacy Services. To guide and support others undertaking research audit and service improvements e.g., Trainee Pharmacists or Diploma Pharmacists. To record, monitor and evaluate the effectiveness of pharmaceutical interventions and contributions to ward rounds and Directorate. To analyse and undertake root cause analysis of medication incidents

Other Duties To undertake duties elsewhere in the locality, if required. To undertake on call duties To provide a pharmacy service at weekends

Person Specification

Education, Training and Qualifications

Essential

• Pharmacy Degree, MPharm or BPharm
• Independent prescribing or willing to work towards Independent Prescribing qualification
• Registered with General Pharmaceutical Council
• Diploma in Clinical Pharmacy or equivalent
• Mandatory CPD Portfolio

Desirable

• MSc in Clinical Pharmacy
• Member of Royal College of Pharmacy
• Formal Management training
• Diploma Tutor accreditation

Knowledge and Experience

Essential

• Extensive operational experience at a Senior Hospital Pharmacist level, demonstrating a high degree of autonomy
• Experience of supporting Divisional Pharmacist or equivalent, to include financial expenditure reporting, formulary application, guideline writing
• Experience with working as part of a multidisciplinary team
• Teaching, supervising and training staff

Desirable

• Experience of practice research or audits

Skills

Essential

• Demonstrates a level of clinical reasoning, problem solving and judgement
• IT skills with Word, Excel
• Ability to work independently and as a member of a multidisciplinary team

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Northampton General Hospital

Address

University Hospitals of Northamptonshire

Northamptonshire

Northampton

NN1 5BD

United Kingdom

Employer's website

https://www.northamptongeneral.nhs.uk/Home.aspx (Opens in a new tab)

Job description

Job responsibilities

Please see attached Job Description for further information about the Medical Engineer position available at WUTH.

Person Specification

Qualifications, Specific Experience & Trainin

Essential

• Minimum BSc in Electronic/Mechanical Engineering or HND/C in Electronic/Mechanical Engineering +3 yrs post graduate engineering experience

Desirable

• Post graduate Bio-Medical Engineering and physiological training

Knowledge and Skills

Desirable

• Attended manufacturer's courses on medical equipment maintenance

Personal Attributes

Essential

• A team player able to work well with others and demonstrate commitment to departmental objectives
• A flexible approach to introduction of change in working practices

Desirable

• Self-motivated and enthusiastic

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Wirral University Teaching Hospitals NHS Trust

Address

Arrowe Park Hospital

Arrowe Park Road

Upton

CH49 5PE

United Kingdom

Employer's website

https://www.wuth.nhs.uk (Opens in a new tab)

Job description

Job responsibilities

For further information on this role, please see the attached detailed Job Description and Person Specification

Initiate and manage day to day running of allocated trial(s) in accordance with Good Clinical Practice (GCP) and RMH / ICR Standard Operating Procedures (SOPs) To complete applications to Research Ethics Committees (REC), Medicines and Healthcare products Regulatory Agency (MHRA) and Committee for Clinical Research (CCR)/R&D for new research proposals To ensure trials do not commence until all regulatory, sponsor and local R&D requirements are satisfied Ensure delegation logs are in place for trials and that these are kept up to date Set up and maintain training records as appropriate for staff working on trials To liaise with commercial companies and other funders to establish funding and sponsor contracts for trials and to ensure adequate drug supply for the duration of the trials To liaise with R&D to ensure appropriate material transfer arrangements are in place for trials involving transfer or receipt of tissue Responsible for essential trial documentation compilation and maintenance in Trial Master Files / Trial Site Files / eFiles To liaise with the R&D, pharmacy, finance, contracts and laboratories in set up of trials To assist with data entry and review for the commercial hosted clinical trials.

Person Specification

Education/Qualifications

Essential

• Life sciences (or equivalent) degree

Experience

Essential

• Understanding of clinical trials and regulations governing clinical research
• Minimum of one year's experience of working in a clinical trials setting
• Experience of data entry and data management

Desirable

• Recent Good Clinical Practice training
• Experience of working in the NHS
• Experience of working in the field of cancer

Skills Abilities/knowledge

Essential

• Excellent administrative and organisational skills
• Excellent IT skills including access, excel and power point
• Excellent oral and written communication skills
• Ability to work effectively as part of a team
• Ability to prioritise effectively and manage own workload
• Ability to interact confidently with experts and nonexperts alike
• Ability to maintain adherence to written procedures
• Good attention to detail

Other Requirements

Desirable

• Willingness to travel within the UK and occasionally overseas to attend meetings and conferences
• Willingness to be flexible around contracted working hours ie to attend MDT/research meetings etc

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

The Royal Marsden NHS Foundation Trust

Address

The Royal Marsden Chelsea

Chelsea

SW3 6JJ

United Kingdom

Employer's website

https://www.royalmarsden.nhs.uk/working-royal-marsden (Opens in a new tab)

Job description

Job responsibilities

For further information please refer to the job description and personal specification

• Develop, in collaboration with GCP and Regulatory Compliance Team, the risk based audit programme.
• Continually monitor and assess emerging risks associated with research portfolio and perform triggered audits as required.
• Plan, undertake and produce audit reports both independently and as part of the GCP and Regulatory Compliance Team.
• Create and develop the tools necessary to undertake and report audits.
• Foster positive working relationships with research stakeholders to ensure audit programme is delivered successfully.
• Categorise findings in accordance with Trust standards and escalate major and critical findings where necessary

Person Specification

Education/Qualifications

Essential

• Educated to degree level or equivalent experience in clinical research
• Recognised GCP training

Experience

Essential

• Experience of working to UK Clinical Trials Regulations
• Experience of working in the NHS or relevant clinical / research environment
• Experience of monitoring or auditing clinical trials
• Experience of working across organisational boundaries with multidisciplinary teams

Desirable

• Experience of working with non-commercial clinical studies

Skills Abilities/knowledge

Essential

• Detailed knowledge of UK Clinical trial regulations, GCP and regulatory framework
• Ability to read and understand clinical research protocols
• Ability to summarise and explain complex issues to both technical and non-technical audiences
• Willing and able to coach and train others
• Excellent administrative and organisational skills
• Proficient in the using PC based Windows and Microsoft Office software including Access & PowerPoint
• Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately
• Ability to work well within a multi-disciplinary team environment
• Able to work under pressure, methodical in approach, with effective problem-solving ability
• A high level of accuracy and attention to detail
• Ability to work on own initiative
• Proven ability to organise own work in busy work environment and time critical situations

Other Requirements

Essential

• Flexible to meet the needs of the service (e.g., working ad hoc to support regulatory inspections)
• Able to work on both sites and to be flexible to meet the needs of the role

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

The Royal Marsden NHS Foundation Trust

Address

The Royal Marsden Sutton

Sutton

SM2 5PT

United Kingdom

Employer's website

https://www.royalmarsden.nhs.uk/working-royal-marsden (Opens in a new tab)

Job description

Job responsibilities

Main Tasks

• Manages the Quality Control and Assurance Service ensuring compliance with national standards and statute.
• Supports the Managing Director in setting the strategic direction for the Quality Control and Assurance Service.
• Actively contributes to the development of the annual business plan and strategic planning for HPS.
• Ensures that the Quality Control and Assurance Service fulfils HPSs objectives and is provided within allocated financial resources.
• When required to and related to quality aspects, contributes to the writing and assessment of product dossiers being developed for submission to regulatory authorities (e.g. the MHRA) for new product licences.
• Undertakes the following responsibilities for sterile and non-sterile pharmaceutical. manufacturing, aseptic manufacturing and extemporaneous product manufacture as outlined in the Rules and Guidance for Pharmaceutical Manufacture (GMP):
• To approve or reject starting materials, packaging and intermediate bulk and finished products
• To evaluate batch records
• To ensure that all necessary testing is carried out
• To approve specifications, sampling instructions, test methods and other QC procedures
• To approve and monitor any contract analysts
• To check the maintenance of the QC laboratory and equipment
• To ensure that appropriate validations are performed
• To co-ordinate and perform self-inspections of all manufacturing areas
• To deal with complaints from external customers relating to products supplied by HPS.
• To act as the internal investigation co-ordinator for HPS.
• Undertakes the following shared responsibilities relating to quality with the Head of Production:
• The authorisation of written procedures
• The monitoring and control of the sterile, non-sterile and aseptic manufacturing environments
• Plant hygiene
• Process validation
• Training
• The approval and monitoring of suppliers and contract manufacturers
• The designation and monitoring of storage conditions for medicines and raw materials used in the production unit.
• The retention of records
• The monitoring of compliance with the requirements of GMP
• To monitor factors which may affect product quality
• Is responsible for ensuring that all HPS manufacturing licences are maintained, and that any non-compliances arising from regulatory inspections are addressed within the timescales agreed with the medicines regulator (MHRA).
• Acts as the responsible Person in regard to all aspects of Good Distribution Practice for all operations undertaken by HPS.
• Ensures that all other legislation that impacts on the service is prioritised and complied with e.g. Health and Safety, Environmental issues, COSHH, CLP, etc.
• Is responsible, in co-operation with the Managing Director, for the development of new production control systems and the development of new or modified formulations.
• Leads on and works in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions (CAPAs), as applicable according to SOPs.
• Collaborates on and contributes to development projects, both initiated internally by HPS and externally by HPS customers.
• Is responsible for creating, monitoring and delivering Quality Control and Assurance based key performance indicators (KPIs) and ensures all routine work and projects are delivered on cost and on time.
• Is responsible for, and provides advice and guidance on, the implementation of the COSHH regulations.
• Undertakes quality assurance audits for all sections of HPS.
• Ensures there is a continuous improvement program to optimise processes.
• Is responsible for the provision of environmental monitoring for HPS.
• Is responsible for the recruitment and selection of staff working within Quality Control and Assurance departments.
• Implements Trust human resource policies in relation to the Quality Control and Assurance Service and undertakes sickness and absence, capability and disciplinary reviews.
• Is responsible for the management of the staffing budget for the Quality Control and Assurance service and advises the Managing Director on resource requirements for service provision.
• Acts as an authorised signatory within HPS of delegated authority.
• Continually reviews and improves the quality and standard of service provision through consultation with users of the Quality Control and Assurance service.
• Develops and maintains policies, procedures and records for the Quality Control and Assurance service.
• Ensures the appropriate stock control and storage of materials and safe maintenance of equipment used in the provision of the services managed by the post holder.
• Ensures that all staff working in services managed by the post holder are competent to perform their duties, receive appropriate training, an annual appraisal and personal development plan.
• Is responsible for the management of risk in relation to services managed by the post holder.
• In collaboration with the Managing Director, develops a culture that encourages the use of initiative, individual and team responsibilities, open communication and a corporate approach to decision making which takes into account HPS priorities.
• Develops and maintains working relationships with users and customers of HPS and Quality Control and Assurance services to continually improve the quality and standard of service provided.
• Attends and represents HPS at regional and local Quality Control and Assurance and technical services meetings, and if necessary, NHS national working groups.
• Covers the duties of other senior staff during periods of sickness and absence and undertakes any other reasonable duties including weekend provision of services.
• Alongside other colleagues, participates in an on-call service to ensure that manufacturing and Quality Control and Assurance operations are adequately maintained on a continuous basis.
• Prepares routine and ad-hoc board reports.

Person Specification

QUALIFICATIONS / TRAINING

Essential

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology or equivalent. Full professional membership of a relevant professional body (e.g. MRPharmS, CChem)
• Eligible for nomination as a QP (as defined by the joint professional bodies)
• Relevant post graduate qualification e.g. PhD, Masters or Post graduate Diploma in Pharmaceutical Technology and Quality Assurance

Desirable

• Relevant post graduate qualification e.g. PhD, Masters or Post graduate Diploma in Pharmaceutical Technology and Quality Assurance
• Currently practicing as a QP

KNOWLEDGE, EXPERIENCE & EXPERTISE

Essential

• Substantial/significant experience QA/QC in QA/GMP environment/s at a high level which the post holder can relate to current NHS Manufacturing and Quality Assurance services.
• Expertise should include extensive development and management of Quality Management Systems
• A strong track record in preparing for, hosting and achieving satisfactory outcomes from regulatory GMP audits (MHRA / FDA)
• Experience in completing the quality sections of marketing authorisation applications that are submitted to medicine regulators in-order to obtain product licences
• Detailed knowledge and understanding of Pharmaceutical Manufacture, Good Manufacturing Practice, Good Distribution Practice and Good Control Laboratory Practice.
• Understanding of legislation relating to pharmaceutical manufacture
• Computer literacy
• Quality audits

Desirable

• Financial management
• Knowledge of ISO9000 Quality System
• Knowledge of product licensing and medical device registration

COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)

Essential

• Leadership and motivational skills
• Highly developed interpersonal and communication skills.
• Ability to prioritise workload and meet deadlines whilst paying attention to detail.
• Ability to work under pressure.
• Ability to work on own initiative and as part of a team.
• Self-motivating and able to motivate/inspire others
• Ability to influence and negotiate with managers, senior medical, nursing and pharmacy staff
• Planning and Organisational skills
• Able to effect and manage change
• Problem solving and analytical skills
• Education & Training skills

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Calderdale and Huddersfield NHS Foundation Trust

Address

Huddersfield Pharmacy Specials

Gate 2 Acre Mill, School Street West

Huddersfield

HD3 3ET

United Kingdom

Employer's website

https://www.cht.nhs.uk (Opens in a new tab)

Job description

Job responsibilities

• Responsible for the management of the Licensed Aseptic Manufacturing Servicesencompassing staff, resources, activity and information.
• In conjunction with the Head of Quality the Head of Production maintains the MHRA licence(s), liaises with regulatory authorities, receiving and assessing complex information that may affect manufacture of medicines.
• To utilise negotiating skills in discussion with Business Managers, Finance Director(s), workforce planning and ICS partners in regard to business and service development.
• To hold regular senior production management meetings to motivate senior staff and monitor /review:-- Personnel / staffing changes / training records and needs/ sickness /error reports- Health and Safety / Accident and Incident reports
• To attend the Quality Management Meeting, ensuring appropriate pharmaceutical quality systems are in place in all departments of the NENE Provider Collaborative Aseptic Hub.
• To liase with QC and QA personnel on a regular basis to ensure compliance with Good Manufacturing Practice.
• To represent the Hub, as required, attending National and Regional Meetings as required by NHSE, ICS and associated National Working Groups
• To provide information, when required, to nursing and medical staff on optimum formulations for stability of all products prepared in the NENC Aseptic Hub.
• To maintain awareness and knowledge of industry development and best practice.
• Ensuring that comprehensive and up-date selection of reference texts and journals is maintained.
• To maintain and further develop where appropriate links with relevant professional bodies and organisations e.g., Royal Pharmaceutical Society, MHRA, Department of Health andSocial Care.

Person Specification

Qualifications

Essential

• Masters degree in a scientific / engineering discipline or equivalent experience
• Registered Professional
• Post-graduate qualification in Pharmaceutical Manufacturing or equivalent experience

Desirable

• Postgraduate diploma in Pharmaceutical Technology and Quality Assurance;
• Management qualification

Experience

Essential

• Advanced theoretical and practical knowledge, gained through training, of technical areas of pharmacy, including pharmaceutical manufacturing, preparation, procurement and contracting, auditing and unlicensed medicines.
• Good knowledge of MHRA Guide to Good Manufacturing Practice, and the British and European pharmacopoeial requirements for raw materials, intermediates and finished products.
• Evidence of successful team management
• Evidence of a leading role in an MHRA Regulatory inspection

Desirable

• Awareness of policies and procedures which impinge on role
• Budgetary planning / financial management experience
• Awareness Corporate and Clinical Governance; Control Assurance Standards within NHS.
• Detailed knowledge of the manufacture of parenteral nutrition, cytotoxic chemotherapy, intravenous additives, Homecare.
• Microbiology/formulation/product design, and the chemical, pharmaceutical and clinical properties of ingredients
• Expert Knowledge of gassing isolators
• Nationally recognised expert in pharmaceutical manufacture.
• Evidence of leading a successful previous pharmaceutical build.
• Evidence of awareness of the NHSE Aseptic Transformation process.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Northumbria Healthcare NHS Foundation Trust

Address

Northumbria Healthcare Manufacturing and Innovation Hub

Avenue Rd

Seaton Delaval, Whitley Bay

NE25 0QJ

United Kingdom

Employer's website

https://www.northumbria.nhs.uk/ (Opens in a new tab)

Job description

Job responsibilities

For further information on this role, please see the attached detailed Job Description and Person Specification:

• The post-holder will undertake the routine aseptic production of both diagnostic and therapeutic radioactive medicinal products for clinical use, operating within the terms of Standard Operating Procedures.
• The post-holder will perform a range of in vitro laboratory tests using unsealed source of radioactivity, operating within the terms of Standard Operating Procedures.
• The post-holder will calculate results from such tests, and enter the confirmed results on to the system for verification by the radiopharmaceutical scientists.
• The post-holder will maintain suitable levels of both stock and non-stock items in the Radiopharmacy, as defined in Standard Operating Procedures.
• To dispose of radioactive waste in accordance with Standard Operating Procedures.
• The post-holder will be required to comply with relevant statutory requirements relating to the manufacture of radioactive medicinal products, including those related to Good Manufacturing Practice, as defined in The Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Medicines and Healthcare products Regulatory Agency).

Person Specification

Education/Qualifications

Essential

• PTQA/HNC/BTech in relevant discipline OR
• Professional knowledge acquired through first degree of related discipline

Desirable

• Registered with the General Pharmaceutical Council (GPhC) as Technician or Healthcare Professional Council (HCPC)
• Membership of an appropriate professional body (Royal College of Pharmacy, Royal Society of Chemistry, Institute of Physics and Engineering in Medicine)
• European Association of Nuclear Medicine Postgraduate Certificate in Radiopharmacy
• Post-graduate qualification (certificate/diploma/MSc) in Radiopharmacy or equivalent knowledge & expertise in the field

Experience

Essential

• Significant operational experience working within a conventional Radiopharmacy/Aseptic facility, to include recent experience at Band 5 or equivalent,
• Experience of aseptic preparation of radiopharmaceuticals or chemotherapy in a licensed facility
• Experience of monitoring of environment / equipment / products relevant to radiopharmacy

Desirable

• Experience in the manufacturing and quality testing of radiopharmaceuticals for clinical use
• Experience of involvement in clinical trial related activities
• Experience in supporting new service development
• Experience in writing reports and Standard Operating Procedure for new processes or new equipment.
• Experience of maintaining a Quality Management System, including investigation of errors and deviations

Skills Abilities/knowledge

Essential

• Able to provide and support the training and development of radiopharmacy staff
• Excellent written / oral communication skills

Other Requirements

Essential

• Able to work early (5:00-13:30) and late shift (08:30-17:00) for prolonged period of time if requested to do so and to be flexible to meet the needs of the role.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

The Royal Marsden NHS Foundation Trust

Address

Royal Marsden Hospital Sutton

Sutton

SM2 5PT

United Kingdom

Employer's website

https://www.royalmarsden.nhs.uk/working-royal-marsden (Opens in a new tab)

Job description

Job responsibilities

The Member must be able to demonstrate the qualities, skills and experience to meet all the essential criteria for appointment. Ideally, experience in management and functional cure of viral hepatitis from an ID/Virology background.

Expertise Required:

Specialist in Viral Hepatitis

Additional expertise in HIV medicine (or any other ID sub-specialty), in viral therapeutics or immunotherapy or in global health issues related to viral hepatitis would be encouraged, but is not essential.

To make an application please email your application form, CV, completed monitoring form and declaration of interest form to: [email protected], quoting the position and reference IEAG26-1 in the subject field.

Please note that applications submitted to [email protected] will be considered only.

Person Specification

Experience

Essential

• The Member must be able to demonstrate the qualities, skills and experience to meet all the essential criteria for appointment.
• Ideally, experience in management and functional cure of viral hepatitis from an ID/Virology background.
• ability to operate effectively on an expert scientific committee current or previous experience of committee membership(s);
• be recognised by their peers as a leader in their field e.g. national academies and Royal Colleges;
• be able to assimilate and interpret complex scientific information and formulate evidence based comments /advice at short notice;
• be able and prepared to contribute actively to the work of the EAG, including on issues outside of own specialism;
• be a skilled communicator;
• be willing to develop a working knowledge and understanding of UK medicines regulatory framework and procedures;
• maintain strict confidentiality with respect to the work of the EAG;
• be willing to declare conflicts of interest;
• be committed to the values of selflessness, integrity, objectivity, accountability, professionalism, impartiality and consistency.

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU

United Kingdom

Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Job description

Job responsibilities

For full details on job description, please refer to advert attached and visit: Herbal Medicine Advisory Committee- GOV.UK

To make an application please email your application form, CV, completed monitoring form and declaration of interest form to: [email protected], quoting the position and reference HMAC26-1 in the subject field.

Please note that applications submitted to [email protected] will be considered only.

Person Specification

Qualifications

Essential

• The Member must be able to demonstrate the qualities, skills and experience to meet all the essential criteria for appointments.
• Have previous or current experience of committee membership
• be a skilled communicator.
• Be able to assimilate complex scientific information at short notice.
• Be able and prepared to contribute actively to the work of HMAC
• Be leaders in their field and recognised as such by their peers
• Be willing to develop a working knowledge and understanding of UK
• medicines regulatory procedures in relation to herbal medicines be willing to declare conflicts of interest and maintain strict confidentiality with respect to the work of the HMAC
• be committed to the values of selflessness, integrity, objectivity,
• accountability, professionalism, impartiality and consistency.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU

United Kingdom

Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Job description

Job responsibilities

Governance and Management

To be a sponsorship specialist for an allocated portfolio of Trust research studies and as such have significant discretion and freedom to act.

Provide guidance to investigators on the requirements for Christie sponsorship.

Advise and support investigators and Research Managers in ensuring appropriate costings are included in studies; to provide resource for sponsorship responsibilities at the grant application stage of agreeing provisional sponsorship or when initially presented with an internally funded study.

Support investigators with compiling documentation for regulatory submissions; Health Research Authority (HRA) including HRA assessment, Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC), Confidentiality Advisory Group (CAG) and site requirements by advising and reviewing documentation.

Review all study related documentation to ensure it is of high standard, consistent with current regulatory requirements and advisory guidance and meets Trust sponsor obligations such as adequate peer review, risk assessment and data management. Ensuring data management plans are in place and that assurances are obtained to verify that the databases are fit for purpose.

Ensure the provision of Investigational Medicinal Product (IMP), placebo or devices as appropriate from approved providers to cover the duration of the trial.

Collaborate with the contracts team to assess and advise on contracts required and provide template documents for the necessary contractual requirements of the study. Review responsibilities, liaise with third parties as required and obtain appropriate authorisations for contracts, sponsorship agreements and study vendors.

Conduct sponsor review of study amendments, ensuring implications are assessed communication and functional areas involved as necessary prior to and changes being actioned.

Implement and follow sponsorship related SOPs.

Contribute to the development maintenance of sponsorship related SOPs and ensure their compliance with regulatory and Trust requirements. Implement changes to policy, and relevant SOPs, when national guidance changes within the sponsorship arena.

To contribute and assist in the preparation for external audit, monitoring and regulatory inspection by external agencies such as the MHRA.

Co-ordinating remedial action and ensuring completion of tasks in relation to CAPA planned following monitoring, audit. Inspection or incident/deviation related issues.

Work within sponsorship team to ensure routine processes implemented to meet sponsor obligations during study set-up, green-light (including other sites), regulatory reporting (e.g. progress reports and end of study reports), study closure and study results and publications.

Work to ensure activities are well planned and organised and tracked due to the varied nature of specific studies and the unpredictable workload involved.

Provide oversight of the management of Trust sponsored studies. Ensuring Trial Management Group meetings take place and attend where required, ensuring Trial Steering Committees and Data Management Committees are in place as required. Ensuring Clinical Trials Units, or other vendors, undertake their delegated contractual duties appropriately and in a timely fashion. Ensure Study Initiation Visits (SIVs) have taken place when required.

Receive and review progress reports as determined by the study risk management plan escalating any concerns as necessary.

Manage to resolution issues identified through the Trust monitoring and audit programme, which are the sponsors responsibility to action and oversee.

Maintain precise and accurate records that document the decisions made on behalf of the sponsor for the lifetime of the study.

Responsible for the operation of sponsor information systems (project planning tools and trackers) managing and maintaining the data within and developing where required for the Trust.

Contribute to the oversight of study budgets by working with the R&I grants and income and costing functions.

Work with project teams and cross functional teams to ensure that study budgets are reconciled in a timely manner at the end of the study.

Engage actively with investigators, academic collaborators, clinical research fellows, nurses, support departments, academic departments and external organisations to ensure they receive appropriate and tailored support.

Ensure all stakeholders are informed and involved at every level of sponsorship reviews.

Provide investigators with the necessary information on NIHR, HRA, MHRA and Trust processes. This may include multidisciplinary meetings, website and producing and maintaining other information materials.

Answer queries relating to legislation and the conduct of research from research staff promptly and efficiently. This information may be complex in nature, so good communication skills are required to make the information understandable to varying levels of staff. Acknowledging all communication from investigators and key stakeholders and ensuring an efficient flow of information.

Ensure there is good internal communication, with members of R&I infrastructure staff, of decision making and sponsorship pathway progress. Tact and sensitivity will need to be used when delivering negative news to recipients.

When communicating with external organisations, such as CTUs or other vendors, professionalism, persuasion, negotiation and assertiveness will be required to ensure the Trust receives the services required. There may also be a need to discuss shortcomings of the service being delivered where necessary in conjunction with other members of the R&I team.

Provide effective leadership on sponsorship matters and know when to escalate to sponsorship manager.

Participate in recruitment of staff to the R&I central office and act as supervisor/mentor as required.

Person Specification

Qualifications

Essential

• Post graduate diploma level in a scientific discipline or equivalent experience

Desirable

• Evidence of continuing professional development

Experience

Essential

• Previous experience of working within clinical research setting
• Experience of writing procedural/patient documentation
• Experience of working to deadlines

Skills

Essential

• Ability to assess and interpret complicated and conflicting information and use judgement where appropriate
• Ability to listen to others and use critical questioning techniques to identify core issues/risks within proposals
• Organisational and time management skills
• Interpersonal skills- Good written and oral communication skills
• Ability to work under pressure to tight timelines

Desirable

• Ability to use spreadsheets
• Ability to create PowerPoint presentations and other Microsoft office applications
• Advanced computer literacy and ability to adapt and learn new computer applications

Knowledge

Essential

• Knowledge of research sponsorship responsibilities
• Comprehensive knowledge and understanding of standards and legislation that govern research practice in the NHS.
• Comprehensive knowledge and understanding of NHS research governance processes, including amendments
• Knowledge of regulatory issues surrounding the conduct of clinical research
• Awareness of research within the NHS and legislative framework within the UK

Desirable

• Knowledge of quantitative and qualitative research methodologies
• Understanding of clinical trial protocol requirements
• Understanding of study data management systems.
• Knowledge of international research, and conduct.

Values

Essential

• Ability to demonstrate the organisational values and behaviours

Other

Essential

• Able to work and act independently
• Ability to work across functional and organisational boundaries
• Good attention to detail
• Positive approach
• Flexible and motivated team player

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

The Christie NHS FT

Address

R&D Office - Q01552

Manchester

M20 4BX

United Kingdom

Employer's website

https://www.christie.nhs.uk/ (Opens in a new tab)