10 jobs found for biotechnology pharmaceutical

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    • maidenhead, berkshire
    • contract
    • £50.00 - £55.00 per hour
    • full-time
    6 Month Contract - Senior Manager - EU+ Regulatory Life cycle StrategyAs Senior manager, you will contribute to the development and implementation of EU regional clinical and pre-clinical regulatory strategy for products post MAA approval, in alignment with the EU business strategy. As Senior Manager- EU Regulatory, you will be responsible for:Leading the planning, coordination and preparation of regulatory submissions, supporting the EU Regulatory Lead for products post MAA approval Identify and assess regulatory risks associated with assigned projects and overall product development. Assist in defining strategies to mitigate risks.Provide leadership and represent regulatory on project teams for assigned projectsRepresent the company for defined projects with local and regional regulatory authorities, contractors and corporate partnersSecure alignment between regulatory functionsProvide leadership on project teams and subcommittees in all areas of regulatory science and product developmentProvide input to Regulatory Senior Management teamsProvide regulatory guidance to company personnel throughout the research and development processLead preparation and participate in specific areas of Health Authority MeetingsMonitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess impact on assigned programsBuild and maintain relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company positionResponsible for defining strategies for meeting and keeping post approval complianceTo be considered for the role of Senior Manager, you will have the following Experience:Minimum 5+ years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 2 years in Regulatory Sciences.EU regulatory experience managing submissions essential.Experience in interpretation of regulations, guidelines and policy statements.Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.Some direct experience in interfacing with relevant regulatory authorities.Foster effective, positive interactions with regulatory agencies, and corporate partners.Ability to work both independently and with minimal direction and within project teams, committees, etc. to attain group goals.To be considered for the position of Senior Manager, you will be educated to BA/BS/University degree level, Life/Health Sciences preferred.This is a 6 Month initial contract with the possibility of extension up to 18 months. Salary rate is depending on experience between £40.00 and £55.00 per hour as a PAYE or Umbrella consultant. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    6 Month Contract - Senior Manager - EU+ Regulatory Life cycle StrategyAs Senior manager, you will contribute to the development and implementation of EU regional clinical and pre-clinical regulatory strategy for products post MAA approval, in alignment with the EU business strategy. As Senior Manager- EU Regulatory, you will be responsible for:Leading the planning, coordination and preparation of regulatory submissions, supporting the EU Regulatory Lead for products post MAA approval Identify and assess regulatory risks associated with assigned projects and overall product development. Assist in defining strategies to mitigate risks.Provide leadership and represent regulatory on project teams for assigned projectsRepresent the company for defined projects with local and regional regulatory authorities, contractors and corporate partnersSecure alignment between regulatory functionsProvide leadership on project teams and subcommittees in all areas of regulatory science and product developmentProvide input to Regulatory Senior Management teamsProvide regulatory guidance to company personnel throughout the research and development processLead preparation and participate in specific areas of Health Authority MeetingsMonitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess impact on assigned programsBuild and maintain relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company positionResponsible for defining strategies for meeting and keeping post approval complianceTo be considered for the role of Senior Manager, you will have the following Experience:Minimum 5+ years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 2 years in Regulatory Sciences.EU regulatory experience managing submissions essential.Experience in interpretation of regulations, guidelines and policy statements.Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.Some direct experience in interfacing with relevant regulatory authorities.Foster effective, positive interactions with regulatory agencies, and corporate partners.Ability to work both independently and with minimal direction and within project teams, committees, etc. to attain group goals.To be considered for the position of Senior Manager, you will be educated to BA/BS/University degree level, Life/Health Sciences preferred.This is a 6 Month initial contract with the possibility of extension up to 18 months. Salary rate is depending on experience between £40.00 and £55.00 per hour as a PAYE or Umbrella consultant. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    • maidenhead, berkshire
    • work from home - contract
    • £50.00 - £70.00 per hour
    • full-time
    Are you an experienced Senior PV Scientist? Are you looking to take on a new challenge with a leading business that are pioneers in Neuroscience? If so we are looking for individuals just like you!You will be the product lead for Pharmacovigilance activities within our clients medical function. The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist also serves as a Subject Matter Expert for SABR and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.Role/Benefits:Contract 6-18 months Remote working Weekly payHoliday payPension plan Responsibilities:Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.Collaborates with Global Safety Officers and other SABR MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.) safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.Leads process for responding to safety questions from regulatory authorities. Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.Leads and collaborates with Aggregate Reports on strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs). Experience and skills:Strong Pharmacovigilance experienceExperience in aggregate safety reports and safety signal managementStrong background in clinical trial drug safety is requiredUnderstands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).If you feel you have the right experience and skills for this role, and would be interested in applying, please click apply, making sure to send an up to date CV, ensuring your up to date contact details are also on your CV. We will make sure to contact you as soon as we hear back from our client to discuss the job role further. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    Are you an experienced Senior PV Scientist? Are you looking to take on a new challenge with a leading business that are pioneers in Neuroscience? If so we are looking for individuals just like you!You will be the product lead for Pharmacovigilance activities within our clients medical function. The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist also serves as a Subject Matter Expert for SABR and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.Role/Benefits:Contract 6-18 months Remote working Weekly payHoliday payPension plan Responsibilities:Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.Collaborates with Global Safety Officers and other SABR MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.) safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.Leads process for responding to safety questions from regulatory authorities. Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.Leads and collaborates with Aggregate Reports on strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs). Experience and skills:Strong Pharmacovigilance experienceExperience in aggregate safety reports and safety signal managementStrong background in clinical trial drug safety is requiredUnderstands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).If you feel you have the right experience and skills for this role, and would be interested in applying, please click apply, making sure to send an up to date CV, ensuring your up to date contact details are also on your CV. We will make sure to contact you as soon as we hear back from our client to discuss the job role further. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    • maidenhead, berkshire
    • contract
    • £36,000 - £40,000 per year
    • full-time
    JOB ROLE: Contracts Specialist LOCATION: Remote TYPE: Contract PAY RATE: Market rate Are you a pragmatic Contracts Specialist with excellent interpersonal skills and a strong commercial acumen? Do you enjoy building and maintaining relationships? Randstad are recruiting a Contracts Specialist on behalf of a global medical device and healthcare leader, who are dedicated to helping people reach their full health potential. The successful candidate will be responsible for contract communication on contract terms and ensuring contract compliance with internal stakeholders, customers and other 3rd parties. Responsibilities will include: Administration Responsibility for UK Contracts.Maintain appropriate Business Relationships with strategic partners.Responsibility for a regional Contracts Department commercial relationships.Contract support to designated Region Specialists.Quality and Policy Control. Ideal Experience/Qualifications:Minimum of 12-months in contract work.Knowledge of tendering and mini-competitions.Relevant A-level qualification or equivalent in a law, business or life science area.Proficient at analysing and working with large data sets.Advanced Excel skills.CIPS Level 4 or demonstrable equivalent work-related experience is desirable.Broad understanding of the diagnostic industry and NHS is desirable.Do you have excellent interpersonal skills with a high level of attention to detail? Are you interested in working for a company who makes a genuine difference to people's lives? Apply today to hear more about this great opportunity!Randstad Business Support is acting as an Employment Business in relation to this vacancy.
    JOB ROLE: Contracts Specialist LOCATION: Remote TYPE: Contract PAY RATE: Market rate Are you a pragmatic Contracts Specialist with excellent interpersonal skills and a strong commercial acumen? Do you enjoy building and maintaining relationships? Randstad are recruiting a Contracts Specialist on behalf of a global medical device and healthcare leader, who are dedicated to helping people reach their full health potential. The successful candidate will be responsible for contract communication on contract terms and ensuring contract compliance with internal stakeholders, customers and other 3rd parties. Responsibilities will include: Administration Responsibility for UK Contracts.Maintain appropriate Business Relationships with strategic partners.Responsibility for a regional Contracts Department commercial relationships.Contract support to designated Region Specialists.Quality and Policy Control. Ideal Experience/Qualifications:Minimum of 12-months in contract work.Knowledge of tendering and mini-competitions.Relevant A-level qualification or equivalent in a law, business or life science area.Proficient at analysing and working with large data sets.Advanced Excel skills.CIPS Level 4 or demonstrable equivalent work-related experience is desirable.Broad understanding of the diagnostic industry and NHS is desirable.Do you have excellent interpersonal skills with a high level of attention to detail? Are you interested in working for a company who makes a genuine difference to people's lives? Apply today to hear more about this great opportunity!Randstad Business Support is acting as an Employment Business in relation to this vacancy.
    • peterborough, cambridgeshire
    • permanent
    • £45,000 - £50,000, per year, Depending on experience
    • full-time
    Our client, a Medical device business, is looking for a Regulatory Affairs Specialist to join the Quality and Compliance team. Promoting flexible working as a company, although we are very conscious that this role is likely to be more successful in its delivery where there is a routine of regular attendance to our office in Peterborough or Kings Lynn. At its core, our client is a specialist medical technology business developing, manufacturing, and supplying products and services to enable hospitals and healthcare facilities to reduce the risk of infection. The Regulatory Affairs Specialist will report to the Quality and Compliance Manager and will be a key aid to the business. As a Regulatory Affairs Specialist you will use your knowledge of the regulatory landscape to ensure products are developed, manufactured, and distributed according to required regulations and standards. Main responsibilities:Maintain product compliance matrix document tracking compliance changes and requirementsLiaise with external parties (i.e., compliance consultants)Ensure products meet regulatory and technical standardsShare knowledge of regulationsDemonstrate compliance with global regulationsPrepare data to obtain certifications and commercialisation authorisationsCompilation and submission of dossiers and ensuring suitability of product labelling and advertising for all products types in international marketsPrepare safety data sheetsTrack/report on assigned projectsManage relevant technical documentation and files Experience required for this position:Strong knowledge of scientific, regulatory, and business issuesExperience with a BPR/MDR background (cosmetic may be considered)3+ years' experience in a similar role is essentialKnowledge of EU, US and Asian markets is essentialPrevious experience of ensuring compliance with MDR and BPRRelevant Science backed degreeExcellent knowledge of regulatory frameworks (BPR, MDR, FDA, CE marking, UKCA)Experience in International Standards (ISO 13485 & 14971)Knowledge of IEC 60601 seriesKnowledge of design control, software lifecycle and risk management processesExperience registering biocidal products and medical devices Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    Our client, a Medical device business, is looking for a Regulatory Affairs Specialist to join the Quality and Compliance team. Promoting flexible working as a company, although we are very conscious that this role is likely to be more successful in its delivery where there is a routine of regular attendance to our office in Peterborough or Kings Lynn. At its core, our client is a specialist medical technology business developing, manufacturing, and supplying products and services to enable hospitals and healthcare facilities to reduce the risk of infection. The Regulatory Affairs Specialist will report to the Quality and Compliance Manager and will be a key aid to the business. As a Regulatory Affairs Specialist you will use your knowledge of the regulatory landscape to ensure products are developed, manufactured, and distributed according to required regulations and standards. Main responsibilities:Maintain product compliance matrix document tracking compliance changes and requirementsLiaise with external parties (i.e., compliance consultants)Ensure products meet regulatory and technical standardsShare knowledge of regulationsDemonstrate compliance with global regulationsPrepare data to obtain certifications and commercialisation authorisationsCompilation and submission of dossiers and ensuring suitability of product labelling and advertising for all products types in international marketsPrepare safety data sheetsTrack/report on assigned projectsManage relevant technical documentation and files Experience required for this position:Strong knowledge of scientific, regulatory, and business issuesExperience with a BPR/MDR background (cosmetic may be considered)3+ years' experience in a similar role is essentialKnowledge of EU, US and Asian markets is essentialPrevious experience of ensuring compliance with MDR and BPRRelevant Science backed degreeExcellent knowledge of regulatory frameworks (BPR, MDR, FDA, CE marking, UKCA)Experience in International Standards (ISO 13485 & 14971)Knowledge of IEC 60601 seriesKnowledge of design control, software lifecycle and risk management processesExperience registering biocidal products and medical devices Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    • dundee, dundee
    • temporary
    • £10.00 - £100.00 per hour
    • full-time
    JOB ROLE: Manufacturing Scientist LOCATION: DundeeTYPE: ContractPAY RATE: Market rate Are you a driven Manufacturing Scientist who can promote a positive, high performance environment? Are you prepared to step up and make a difference? Randstad is recruiting a Manufacturing Scientist on behalf of a global medical device and healthcare leader, who are dedicated to helping people reach their full health potential. The successful candidate will work closely with other staff and support functions to ensure delivery of bulks, in full, on time and of the expected quality. Whilst being vigilant for improvement opportunities and showing an enthusiasm to implement them. Responsibilities will include: Plan and coordinate activities for specified job assignments.Work with the team to ensure on-time delivery of the product.Actively involved in 5S and other general housekeeping duties.To work with R&D staff to transfer robust and effective methodology.Develop in-depth knowledge of the processes and procedures used.Actively seek out and contribute to continuous improvements activities.Positively contribute to the Department to provide support activities, including oversight and accountability.To be familiar with and adhere to the company's Health and Safety Policy.Where required, plan and coordinate transfer activities for specified reagents. Facilitate the efficient transfer of technology, knowledge and practical know-how into the group by way of training and support. Ideal Skills/Experience:Knowledge of GMP and manufacturing processes and procedures.Good IT skills.Basic knowledge of CAPA, DOPs and Validation processes.Able to demonstrate and promote a high performance, high accountability environment.Experience within a production environment is ideal (EG Pharma, Food, Chemical)Are you a self starter who is able to positively contribute to the work environment? Are you interested in working for a company who makes a genuine difference to people's lives? Apply today to hear more about this great opportunity!Randstad Business Support is acting as an Employment Business in relation to this vacancy.
    JOB ROLE: Manufacturing Scientist LOCATION: DundeeTYPE: ContractPAY RATE: Market rate Are you a driven Manufacturing Scientist who can promote a positive, high performance environment? Are you prepared to step up and make a difference? Randstad is recruiting a Manufacturing Scientist on behalf of a global medical device and healthcare leader, who are dedicated to helping people reach their full health potential. The successful candidate will work closely with other staff and support functions to ensure delivery of bulks, in full, on time and of the expected quality. Whilst being vigilant for improvement opportunities and showing an enthusiasm to implement them. Responsibilities will include: Plan and coordinate activities for specified job assignments.Work with the team to ensure on-time delivery of the product.Actively involved in 5S and other general housekeeping duties.To work with R&D staff to transfer robust and effective methodology.Develop in-depth knowledge of the processes and procedures used.Actively seek out and contribute to continuous improvements activities.Positively contribute to the Department to provide support activities, including oversight and accountability.To be familiar with and adhere to the company's Health and Safety Policy.Where required, plan and coordinate transfer activities for specified reagents. Facilitate the efficient transfer of technology, knowledge and practical know-how into the group by way of training and support. Ideal Skills/Experience:Knowledge of GMP and manufacturing processes and procedures.Good IT skills.Basic knowledge of CAPA, DOPs and Validation processes.Able to demonstrate and promote a high performance, high accountability environment.Experience within a production environment is ideal (EG Pharma, Food, Chemical)Are you a self starter who is able to positively contribute to the work environment? Are you interested in working for a company who makes a genuine difference to people's lives? Apply today to hear more about this great opportunity!Randstad Business Support is acting as an Employment Business in relation to this vacancy.
    • witney, oxfordshire
    • temporary
    • £9.83 per hour
    • full-time
    Job Title: Production Assistant Location: Witney, Oxfordshire Contract: 12 weeks Hourly rate: £9.83 Position Summary: The operation is producing inks preparation, Screen Printed electrodes, foiled packaged electrodes used for self or medical diagnosis. The electrodes have to be produced to the strict guild lines of the Standard Operating Procedures (SOPs) for each operation in the process. They must conform to the Good Manufacturing Practice (GMP) and the Food and Drug Administration Regulations. Additional Main Responsibilities: To maintain good timekeeping for all the tasks, to conform to Company requirements for behaviour and correct working attire.To work under the direction of the Team Manager or Supervisor to perform tasks to the Standard Operating Procedure.To set up and operate, under the direction of the Team Manager, all machines within the Area to Standard Operating Procedures.To inspect visually or with the use of specified instruments, as directed, materials for failures or imperfections following the relevant Standard Operating Procedures.To liaise, where the occasion demands, with other Departments.To monitor and ensure compliance with the ADC quality system, good manufacturing practice and regulatory requirements.To assist in projects to enhance the effectiveness and efficiency of the quality system and product quality.Ensure compliance with EHS regulations and Abbott standards by adhering to EHS systems, programmes and procedures, being accountable for the Health & Safety of themselves and others and by highlighting where improvements to EHS performance can be made. Additional Qualifications: GCSE Level (but not essential as one to one on the job training is given).No previous experience required, as one to one on the job training is given.Basic understanding of Maths and English for use with data entry to batch records and settings on machinery. Apply now to get your CV in front of the hiring manager! Randstad Business Support is acting as an Employment Business in relation to this vacancy.
    Job Title: Production Assistant Location: Witney, Oxfordshire Contract: 12 weeks Hourly rate: £9.83 Position Summary: The operation is producing inks preparation, Screen Printed electrodes, foiled packaged electrodes used for self or medical diagnosis. The electrodes have to be produced to the strict guild lines of the Standard Operating Procedures (SOPs) for each operation in the process. They must conform to the Good Manufacturing Practice (GMP) and the Food and Drug Administration Regulations. Additional Main Responsibilities: To maintain good timekeeping for all the tasks, to conform to Company requirements for behaviour and correct working attire.To work under the direction of the Team Manager or Supervisor to perform tasks to the Standard Operating Procedure.To set up and operate, under the direction of the Team Manager, all machines within the Area to Standard Operating Procedures.To inspect visually or with the use of specified instruments, as directed, materials for failures or imperfections following the relevant Standard Operating Procedures.To liaise, where the occasion demands, with other Departments.To monitor and ensure compliance with the ADC quality system, good manufacturing practice and regulatory requirements.To assist in projects to enhance the effectiveness and efficiency of the quality system and product quality.Ensure compliance with EHS regulations and Abbott standards by adhering to EHS systems, programmes and procedures, being accountable for the Health & Safety of themselves and others and by highlighting where improvements to EHS performance can be made. Additional Qualifications: GCSE Level (but not essential as one to one on the job training is given).No previous experience required, as one to one on the job training is given.Basic understanding of Maths and English for use with data entry to batch records and settings on machinery. Apply now to get your CV in front of the hiring manager! Randstad Business Support is acting as an Employment Business in relation to this vacancy.
    • maidenhead, berkshire
    • contract
    • £61.10 - £71.10 per hour
    • full-time
    Clinical Operations Lead - 18 Month Contract My client, a renowned Pharmaceutical Biotech is looking for a Clinical Operations Lead to join their Medical Research team to develop operational protocol concepts and final protocols. You will use phase and operational experience to implement a study level operational strategy in alignment with the companies Clinical Development Plan and program level strategy. You will also Independently oversee one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partner. **FULL JOB DESCRIPTION TO BE PROVIDED**To be considered for the role of Clinical Operations Lead, you will have the following knowledge and skills:Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development. Ability to establish operational plans and support the CRO in the execution of the plans.Requires a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organisation. Excellent project management skills, including risk assessment and contingency planning. Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development. You will be educated to B.A. or B.S. in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management skills. Experience Required:At least 10 years of clinical research study management experience of which at least 4 years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations. Prior CRO or investigator site and/or monitoring experience is a plus.This is an 18 month contract opportunity with an outstanding Pharmaceutical Biotech based in Maidenhead. Due to COVID 19, this role will initially be remote based, however it is expected that as restrictions ease this role will be office based so any candidate must be commutable to Maidenhead. Due to coming regulations, this role is considered Inside IR35 so engagement must be either PAYE or Umbrella company. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    Clinical Operations Lead - 18 Month Contract My client, a renowned Pharmaceutical Biotech is looking for a Clinical Operations Lead to join their Medical Research team to develop operational protocol concepts and final protocols. You will use phase and operational experience to implement a study level operational strategy in alignment with the companies Clinical Development Plan and program level strategy. You will also Independently oversee one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partner. **FULL JOB DESCRIPTION TO BE PROVIDED**To be considered for the role of Clinical Operations Lead, you will have the following knowledge and skills:Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development. Ability to establish operational plans and support the CRO in the execution of the plans.Requires a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organisation. Excellent project management skills, including risk assessment and contingency planning. Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development. You will be educated to B.A. or B.S. in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management skills. Experience Required:At least 10 years of clinical research study management experience of which at least 4 years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations. Prior CRO or investigator site and/or monitoring experience is a plus.This is an 18 month contract opportunity with an outstanding Pharmaceutical Biotech based in Maidenhead. Due to COVID 19, this role will initially be remote based, however it is expected that as restrictions ease this role will be office based so any candidate must be commutable to Maidenhead. Due to coming regulations, this role is considered Inside IR35 so engagement must be either PAYE or Umbrella company. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    • maidenhead, berkshire
    • contract
    • £32.70 - £42.70, per hour, Negotiable DOE
    • full-time
    Regulatory Strategic Operations Associate = CMC - Six Month Month Contract - REMOTE WORKINGJob Description: As Strategic operations senior associate, you will be providing an operational support to the global regulatory CMC strategic operations team in areas such as budget and vendor management, systems and tools, knowledge management and business process and training. Other duties of the role include: Tracking of information in dashboards, Systems and tools.Generation and coordination of content for Statement of Work and Master Service agreement for new vendors - training will be provided.Document management and organisation.Project management support and coordinating meetingsSupporting the wider department in the onboarding/offboarding process of staff Support training and roll out of material within the department (training will be provided).To be considered for this position, you will have the following experience/ skills: Basic Project management skills; excellent planning and organisational skillsIntegrity - overriding commitment to integrity and high standards in self and othersSolution oriented mindsetGood presentation and training skillsAbility to work both independently with minimal direction and within project teams, committees.Demonstrated competency in planning and tracking projects Proven ability to create strong working relationships in a global setting with many different cultures.Proficient in Microsoft Applications including Microsoft Teams and Planner Education: BS University degree in Information Technology, Business/Project Management or Life Sciences.This is an initial Six Month Contract, with the possibility of extension. Engagement type PAYE or via Umbrella Company. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    Regulatory Strategic Operations Associate = CMC - Six Month Month Contract - REMOTE WORKINGJob Description: As Strategic operations senior associate, you will be providing an operational support to the global regulatory CMC strategic operations team in areas such as budget and vendor management, systems and tools, knowledge management and business process and training. Other duties of the role include: Tracking of information in dashboards, Systems and tools.Generation and coordination of content for Statement of Work and Master Service agreement for new vendors - training will be provided.Document management and organisation.Project management support and coordinating meetingsSupporting the wider department in the onboarding/offboarding process of staff Support training and roll out of material within the department (training will be provided).To be considered for this position, you will have the following experience/ skills: Basic Project management skills; excellent planning and organisational skillsIntegrity - overriding commitment to integrity and high standards in self and othersSolution oriented mindsetGood presentation and training skillsAbility to work both independently with minimal direction and within project teams, committees.Demonstrated competency in planning and tracking projects Proven ability to create strong working relationships in a global setting with many different cultures.Proficient in Microsoft Applications including Microsoft Teams and Planner Education: BS University degree in Information Technology, Business/Project Management or Life Sciences.This is an initial Six Month Contract, with the possibility of extension. Engagement type PAYE or via Umbrella Company. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    • plymouth, devon
    • temporary
    • £10.15 - £15.37, per hour, pension, overtime
    • full-time
    Would you like to work in a clean and dynamic environment for a progressive international company with excellent reputation on the local market and pay rates of up to £15/hr with great temp to perm opportunities?Helping to prepare materials for production at BD plant in Belliver, Plymouth, you would get involved in all aspects of the manufacturing warehouse cycle from receiving and dispatching goods to picking, re-stacking and controlling inventory, honing your attention to detail and time management skills BenefitsCompetitive rates of payFree car parking on siteOn-site canteenMonday - FridayTemp to Perm opportunitiesRandstad benefit app - discounts at many high-street and online retailersPay Rate and Hours of Work: £10.15ph raising after the first 12 weeksVarious Shifts Available ResponsibilitiesTo maintain an accurate account of all goods received, transferred, issued or dispatched in order to achieve high accuracy levels using barcode scanners and SAP systems;To store goods in appropriate locations, ensuring all relevant documentation is completed.To issue goods to internal departments in efficient and timely manner using Bendi Forklift / Tow Tractor / Multi Level Order Picker;To receive and issue goods to/from external suppliers completing all relevant paperwork to maintain control over stock levels;To complete accurate stock inventory checks ;To maintain good housekeeping standards and Health & Safety working practices in order to ensure a safe and hygienic working environment for all members of staff.To carry out visual inspections of departmental Fork Lift Trucks at the beginning of each shift in order to ensure full functioning of the vehicle in line with Health & Safety Regulations.To contribute in a flexible manner in order to enhance the overall performance of the Warehouse. *Please note that driving FLT is only a part of this job and you will be expected to carry out all other stores related tasks as well as listed above Desirable Qualities The ideal candidate will haveGood level of verbal and written English communication skillsGood people skills and the ability to work well within a teamExcellent timekeeping, ambition and desire to succeedRequirements:Applicants must be computer literate.FLT Driving licence and experience is essential.Applicants must be eligible to work in the UK and be able to provide proof of thisApplicants must be over 18 years old.If you'd like to be part of our success please apply with your up-to-date CV to be considered for the role. If pre-selected you will be contacted for a quick telephone interview and the final stage is a group assessment.Due to volume of applications we receive we are unable to provide individual feedback.
    Would you like to work in a clean and dynamic environment for a progressive international company with excellent reputation on the local market and pay rates of up to £15/hr with great temp to perm opportunities?Helping to prepare materials for production at BD plant in Belliver, Plymouth, you would get involved in all aspects of the manufacturing warehouse cycle from receiving and dispatching goods to picking, re-stacking and controlling inventory, honing your attention to detail and time management skills BenefitsCompetitive rates of payFree car parking on siteOn-site canteenMonday - FridayTemp to Perm opportunitiesRandstad benefit app - discounts at many high-street and online retailersPay Rate and Hours of Work: £10.15ph raising after the first 12 weeksVarious Shifts Available ResponsibilitiesTo maintain an accurate account of all goods received, transferred, issued or dispatched in order to achieve high accuracy levels using barcode scanners and SAP systems;To store goods in appropriate locations, ensuring all relevant documentation is completed.To issue goods to internal departments in efficient and timely manner using Bendi Forklift / Tow Tractor / Multi Level Order Picker;To receive and issue goods to/from external suppliers completing all relevant paperwork to maintain control over stock levels;To complete accurate stock inventory checks ;To maintain good housekeeping standards and Health & Safety working practices in order to ensure a safe and hygienic working environment for all members of staff.To carry out visual inspections of departmental Fork Lift Trucks at the beginning of each shift in order to ensure full functioning of the vehicle in line with Health & Safety Regulations.To contribute in a flexible manner in order to enhance the overall performance of the Warehouse. *Please note that driving FLT is only a part of this job and you will be expected to carry out all other stores related tasks as well as listed above Desirable Qualities The ideal candidate will haveGood level of verbal and written English communication skillsGood people skills and the ability to work well within a teamExcellent timekeeping, ambition and desire to succeedRequirements:Applicants must be computer literate.FLT Driving licence and experience is essential.Applicants must be eligible to work in the UK and be able to provide proof of thisApplicants must be over 18 years old.If you'd like to be part of our success please apply with your up-to-date CV to be considered for the role. If pre-selected you will be contacted for a quick telephone interview and the final stage is a group assessment.Due to volume of applications we receive we are unable to provide individual feedback.
    • england
    • permanent
    • £60,000 - £65,000, per year, Car or Car Allowance, Bonus, Pension, 30 days holiday
    • full-time
    Are you looking for a new role as a Commissioning Specialist? Do you have expertise and networks in the fields of commissioning, service development & population health benefits?This role is working for a leading medical devices / technologies business, this role does involve some travel, and overnight stays. (During the lockdown period this role will mainly be online). Benefits: This role can be based anywhere in the UK Bonus / Incentives 30 days annual leave + Bank Holidays Pension Company Car / Car Allowance You will be responsible for: Commissioning of ServicesService re-design and transformationHelping deliver Increased funding for existing services and new servicesHelping deliver increased access to our technology by overcoming health care system barriersUsing your skills and experience to date, develop and deliver strong value propositions aligned to strategic health care decision makers priorities and policiesProactively manage stakeholders with particular focus on Payors (Commissioning Managers/Transformation Managers)Build a Key opinion networkExperience: Strong expertise and experience of commissioning of new servicesExperience of working closely with providers to deliver, monitor and record outcomes achievedEntrepreneurial mindset and ability to think beyond the problem in handExperience of measurement and quantification of health benefits from service redesignEvidence of specialist knowledge and expertise and experience in Project management with a general awareness about project management methodologiesExperience of developing and presenting business cases, briefings and reports to a range of diverse audiences including project boardsCommitment to team-working and respect for the skills of othersDemonstrate effective stakeholder management across different departments and at all levels.Demonstrated capability to plan over short, medium and long-term timeframes and adjust plans and resource requirements accordinglySkilled NegotiatorQualifications: Formal project management qualificationGraduate or similar health care qualificationMasters in Public Health, Economics/Policy or related disciplinesExperience of working across organisations and with other agenciesHighly developed analytical skills with the ability to manage and interpret hard and soft dataKnowledge of lean and large-scale change methodology Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
    Are you looking for a new role as a Commissioning Specialist? Do you have expertise and networks in the fields of commissioning, service development & population health benefits?This role is working for a leading medical devices / technologies business, this role does involve some travel, and overnight stays. (During the lockdown period this role will mainly be online). Benefits: This role can be based anywhere in the UK Bonus / Incentives 30 days annual leave + Bank Holidays Pension Company Car / Car Allowance You will be responsible for: Commissioning of ServicesService re-design and transformationHelping deliver Increased funding for existing services and new servicesHelping deliver increased access to our technology by overcoming health care system barriersUsing your skills and experience to date, develop and deliver strong value propositions aligned to strategic health care decision makers priorities and policiesProactively manage stakeholders with particular focus on Payors (Commissioning Managers/Transformation Managers)Build a Key opinion networkExperience: Strong expertise and experience of commissioning of new servicesExperience of working closely with providers to deliver, monitor and record outcomes achievedEntrepreneurial mindset and ability to think beyond the problem in handExperience of measurement and quantification of health benefits from service redesignEvidence of specialist knowledge and expertise and experience in Project management with a general awareness about project management methodologiesExperience of developing and presenting business cases, briefings and reports to a range of diverse audiences including project boardsCommitment to team-working and respect for the skills of othersDemonstrate effective stakeholder management across different departments and at all levels.Demonstrated capability to plan over short, medium and long-term timeframes and adjust plans and resource requirements accordinglySkilled NegotiatorQualifications: Formal project management qualificationGraduate or similar health care qualificationMasters in Public Health, Economics/Policy or related disciplinesExperience of working across organisations and with other agenciesHighly developed analytical skills with the ability to manage and interpret hard and soft dataKnowledge of lean and large-scale change methodology Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

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