What if you could work with remarkable people on extraordinary things? What if the end result was something a little bit special? What if your role was mission critical? For nearly 70 years, AWE has been at the forefront of nuclear weapons research and development. We have a critical mission: to provide the warheads for the UK s ultimate deterrent - Trident. We also use our unique skills to provide wider UK government with counter-terrorism and nuclear threat reduction solutions. It takes a special sort of person to work at AWE. What if that person was you? Sustainability & Carbon Analyst AWE believes it has a role to play in helping the nation cut its carbon emissions and prepare for a net zero future. This role is to co-ordinate and maintain AWEs corporate environmental performance data collection, analysis and reporting to meet the needs of both external and internal stakeholders. Location - Reading / Basingstoke Area Package - £ 42 , 420 -£ 67 ,000 per annum AWE (one of the best 25 big companies to work for in the UK) offers an attractive array of benefits which include: Market leading contributory pension scheme. Generous holiday entitlement (270 hours a year plus every other Friday off) Flexible working hours Salary sacrifice scheme Consideration for either full time or part time hours. Just let us know on your application if you wish to work part time Relocation package available (terms and conditions apply) Key Responsibilities include: Preparation of carbon compliance reports required for Greenhouse Gas Emissions Permit and UK Emissions Trading Scheme, Streamlined Energy and Carbon Reporting and Climate Change Agreements. Working with stakeholder from across the business to gather and analyse data for AWE s Carbon Footprint and wider sustainability targets. Preparation of internal and external environmental sustainability reports . Monitoring and reporting AWE s Carbon Footprint and progress against Science Based Targets and Net Zero ambitions. Ensure verification of environmental data used for reporting purposes. Update and manage AWEs environmental sustainability dashboards. Contribute to AWEs annual Environmental Sustainability & Governance report, including interface with corporate affairs. Oversee the implementation of AWE s scope 3 strategy, refining data and reporting to allow setting of future reduction targets . Competencies: Knowledge of carbon foot printing. Excellent knowledge of legislation relating to carbon compliance schemes and net zero policies. Practical experience of preparing regulatory reports for carbon management schemes including GHG Emissions Permits and UK Emissions Trading Scheme, Streamlined Energy and Carbon Reporting and Climate Change Agreements. Must have strong analytical and numeracy skills and demonstrate attention to detail. Proficient in the use of Excel and managing large quantities of data ensuring data quality and integrity. Experience of Power BI is preferable. Please note that you must be a British National to apply for a role with us. Our ambition is to create workplaces where we recognise and celebrate differences, encourage diverse contributions and our employees feel able to be themselves at work. We strive to create a genuine culture of openness and inclusion and encourage diverse applicants. Any inclusion information you provide us will be used to encourage and support you through the application process and will be held only for this purpose in accordance with GDPR.
Mar 26, 2024
Full time
What if you could work with remarkable people on extraordinary things? What if the end result was something a little bit special? What if your role was mission critical? For nearly 70 years, AWE has been at the forefront of nuclear weapons research and development. We have a critical mission: to provide the warheads for the UK s ultimate deterrent - Trident. We also use our unique skills to provide wider UK government with counter-terrorism and nuclear threat reduction solutions. It takes a special sort of person to work at AWE. What if that person was you? Sustainability & Carbon Analyst AWE believes it has a role to play in helping the nation cut its carbon emissions and prepare for a net zero future. This role is to co-ordinate and maintain AWEs corporate environmental performance data collection, analysis and reporting to meet the needs of both external and internal stakeholders. Location - Reading / Basingstoke Area Package - £ 42 , 420 -£ 67 ,000 per annum AWE (one of the best 25 big companies to work for in the UK) offers an attractive array of benefits which include: Market leading contributory pension scheme. Generous holiday entitlement (270 hours a year plus every other Friday off) Flexible working hours Salary sacrifice scheme Consideration for either full time or part time hours. Just let us know on your application if you wish to work part time Relocation package available (terms and conditions apply) Key Responsibilities include: Preparation of carbon compliance reports required for Greenhouse Gas Emissions Permit and UK Emissions Trading Scheme, Streamlined Energy and Carbon Reporting and Climate Change Agreements. Working with stakeholder from across the business to gather and analyse data for AWE s Carbon Footprint and wider sustainability targets. Preparation of internal and external environmental sustainability reports . Monitoring and reporting AWE s Carbon Footprint and progress against Science Based Targets and Net Zero ambitions. Ensure verification of environmental data used for reporting purposes. Update and manage AWEs environmental sustainability dashboards. Contribute to AWEs annual Environmental Sustainability & Governance report, including interface with corporate affairs. Oversee the implementation of AWE s scope 3 strategy, refining data and reporting to allow setting of future reduction targets . Competencies: Knowledge of carbon foot printing. Excellent knowledge of legislation relating to carbon compliance schemes and net zero policies. Practical experience of preparing regulatory reports for carbon management schemes including GHG Emissions Permits and UK Emissions Trading Scheme, Streamlined Energy and Carbon Reporting and Climate Change Agreements. Must have strong analytical and numeracy skills and demonstrate attention to detail. Proficient in the use of Excel and managing large quantities of data ensuring data quality and integrity. Experience of Power BI is preferable. Please note that you must be a British National to apply for a role with us. Our ambition is to create workplaces where we recognise and celebrate differences, encourage diverse contributions and our employees feel able to be themselves at work. We strive to create a genuine culture of openness and inclusion and encourage diverse applicants. Any inclusion information you provide us will be used to encourage and support you through the application process and will be held only for this purpose in accordance with GDPR.
Company Introduction Here is a company that is rapidly expanding in the energy supply sector, revolutionising the existing market with an advanced, technology-driven, and customer-centric approach. This organisation is fervently innovative and consistently challenges the norm to provide exceptional services and solutions to its clientele. Recognising that its employees are its most valuable asset, it is committed to their development and success. The company's culture and employee environment are continually evolving, offering new benefits, structured training opportunities, and regular social events. In this organisation, you can be confident that you will receive the necessary support to flourish and become a vital part of their welcoming team. Your Upcoming Role Reporting Analyst Our client is actively looking for a Reporting Analyst to be a part of their commercial data team. In this role, you will collaborate closely with the client's Regulatory and Compliance Officers to meet important regulatory and compliance reporting obligations. Additionally, you will provide critical assistance with key pricing operations and comprehensive business reporting. Job Duties As a Reporting Analyst, your responsibilities will include: Developing, improving, and generating reports using MySQL, Power BI, Excel, and R as necessary to fulfil external regulatory obligations and maintain and enhance internal data integrity. Assuming responsibility for the execution of regular reports, ensuring the results are precise and representative, and meeting external deadlines. Performing insightful ad-hoc analysis using Excel, MySQL, Power BI, and other suitable tools. Guaranteeing effective communication and collaboration across various business departments. Questioning the existing state of affairs to ensure that data collection and reporting practices are both precise and efficient. Essential Qualifications A minimum of 2:1 at degree level or equivalent A minimum of B in A-Level Mathematics or a similar subject or equivalent Proficiency in Excel and at least one programming language such as SQL or R A minimum of two years' experience in an analytical role Experience with SQL, Power BI, and R What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career. Hays Specialist Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found at hays.co.uk
Mar 26, 2024
Full time
Company Introduction Here is a company that is rapidly expanding in the energy supply sector, revolutionising the existing market with an advanced, technology-driven, and customer-centric approach. This organisation is fervently innovative and consistently challenges the norm to provide exceptional services and solutions to its clientele. Recognising that its employees are its most valuable asset, it is committed to their development and success. The company's culture and employee environment are continually evolving, offering new benefits, structured training opportunities, and regular social events. In this organisation, you can be confident that you will receive the necessary support to flourish and become a vital part of their welcoming team. Your Upcoming Role Reporting Analyst Our client is actively looking for a Reporting Analyst to be a part of their commercial data team. In this role, you will collaborate closely with the client's Regulatory and Compliance Officers to meet important regulatory and compliance reporting obligations. Additionally, you will provide critical assistance with key pricing operations and comprehensive business reporting. Job Duties As a Reporting Analyst, your responsibilities will include: Developing, improving, and generating reports using MySQL, Power BI, Excel, and R as necessary to fulfil external regulatory obligations and maintain and enhance internal data integrity. Assuming responsibility for the execution of regular reports, ensuring the results are precise and representative, and meeting external deadlines. Performing insightful ad-hoc analysis using Excel, MySQL, Power BI, and other suitable tools. Guaranteeing effective communication and collaboration across various business departments. Questioning the existing state of affairs to ensure that data collection and reporting practices are both precise and efficient. Essential Qualifications A minimum of 2:1 at degree level or equivalent A minimum of B in A-Level Mathematics or a similar subject or equivalent Proficiency in Excel and at least one programming language such as SQL or R A minimum of two years' experience in an analytical role Experience with SQL, Power BI, and R What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career. Hays Specialist Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found at hays.co.uk
What if you could work with remarkable people on extraordinary things? What if the end result was something a little bit special? What if your role was mission critical? For nearly 70 years, AWE has been at the forefront of nuclear weapons research and development. We have a critical mission: to provide the warheads for the UK s ultimate deterrent - Trident. We also use our unique skills to provide wider UK government with counter-terrorism and nuclear threat reduction solutions. It takes a special sort of person to work at AWE. What if that person was you? Sustainability & Carbon Analyst AWE believes it has a role to play in helping the nation cut its carbon emissions and prepare for a net zero future. This role is to co-ordinate and maintain AWEs corporate environmental performance data collection, analysis and reporting to meet the needs of both external and internal stakeholders. Location - Reading / Basingstoke Area Package - £ 42 , 420 -£ 67 ,000 per annum AWE (one of the best 25 big companies to work for in the UK) offers an attractive array of benefits which include: Market leading contributory pension scheme. Generous holiday entitlement (270 hours a year plus every other Friday off) Flexible working hours Salary sacrifice scheme Consideration for either full time or part time hours. Just let us know on your application if you wish to work part time Relocation package available (terms and conditions apply) Key Responsibilities include: Preparation of carbon compliance reports required for Greenhouse Gas Emissions Permit and UK Emissions Trading Scheme, Streamlined Energy and Carbon Reporting and Climate Change Agreements. Working with stakeholder from across the business to gather and analyse data for AWE s Carbon Footprint and wider sustainability targets. Preparation of internal and external environmental sustainability reports . Monitoring and reporting AWE s Carbon Footprint and progress against Science Based Targets and Net Zero ambitions. Ensure verification of environmental data used for reporting purposes. Update and manage AWEs environmental sustainability dashboards. Contribute to AWEs annual Environmental Sustainability & Governance report, including interface with corporate affairs. Oversee the implementation of AWE s scope 3 strategy, refining data and reporting to allow setting of future reduction targets . Competencies: Knowledge of carbon foot printing. Excellent knowledge of legislation relating to carbon compliance schemes and net zero policies. Practical experience of preparing regulatory reports for carbon management schemes including GHG Emissions Permits and UK Emissions Trading Scheme, Streamlined Energy and Carbon Reporting and Climate Change Agreements. Must have strong analytical and numeracy skills and demonstrate attention to detail. Proficient in the use of Excel and managing large quantities of data ensuring data quality and integrity. Experience of Power BI is preferable. Please note that you must be a British National to apply for a role with us. Our ambition is to create workplaces where we recognise and celebrate differences, encourage diverse contributions and our employees feel able to be themselves at work. We strive to create a genuine culture of openness and inclusion and encourage diverse applicants. Any inclusion information you provide us will be used to encourage and support you through the application process and will be held only for this purpose in accordance with GDPR.
Mar 26, 2024
Full time
What if you could work with remarkable people on extraordinary things? What if the end result was something a little bit special? What if your role was mission critical? For nearly 70 years, AWE has been at the forefront of nuclear weapons research and development. We have a critical mission: to provide the warheads for the UK s ultimate deterrent - Trident. We also use our unique skills to provide wider UK government with counter-terrorism and nuclear threat reduction solutions. It takes a special sort of person to work at AWE. What if that person was you? Sustainability & Carbon Analyst AWE believes it has a role to play in helping the nation cut its carbon emissions and prepare for a net zero future. This role is to co-ordinate and maintain AWEs corporate environmental performance data collection, analysis and reporting to meet the needs of both external and internal stakeholders. Location - Reading / Basingstoke Area Package - £ 42 , 420 -£ 67 ,000 per annum AWE (one of the best 25 big companies to work for in the UK) offers an attractive array of benefits which include: Market leading contributory pension scheme. Generous holiday entitlement (270 hours a year plus every other Friday off) Flexible working hours Salary sacrifice scheme Consideration for either full time or part time hours. Just let us know on your application if you wish to work part time Relocation package available (terms and conditions apply) Key Responsibilities include: Preparation of carbon compliance reports required for Greenhouse Gas Emissions Permit and UK Emissions Trading Scheme, Streamlined Energy and Carbon Reporting and Climate Change Agreements. Working with stakeholder from across the business to gather and analyse data for AWE s Carbon Footprint and wider sustainability targets. Preparation of internal and external environmental sustainability reports . Monitoring and reporting AWE s Carbon Footprint and progress against Science Based Targets and Net Zero ambitions. Ensure verification of environmental data used for reporting purposes. Update and manage AWEs environmental sustainability dashboards. Contribute to AWEs annual Environmental Sustainability & Governance report, including interface with corporate affairs. Oversee the implementation of AWE s scope 3 strategy, refining data and reporting to allow setting of future reduction targets . Competencies: Knowledge of carbon foot printing. Excellent knowledge of legislation relating to carbon compliance schemes and net zero policies. Practical experience of preparing regulatory reports for carbon management schemes including GHG Emissions Permits and UK Emissions Trading Scheme, Streamlined Energy and Carbon Reporting and Climate Change Agreements. Must have strong analytical and numeracy skills and demonstrate attention to detail. Proficient in the use of Excel and managing large quantities of data ensuring data quality and integrity. Experience of Power BI is preferable. Please note that you must be a British National to apply for a role with us. Our ambition is to create workplaces where we recognise and celebrate differences, encourage diverse contributions and our employees feel able to be themselves at work. We strive to create a genuine culture of openness and inclusion and encourage diverse applicants. Any inclusion information you provide us will be used to encourage and support you through the application process and will be held only for this purpose in accordance with GDPR.
If you've been looking for a company allowing you to work remotely, this is it. We are looking to hire a Regulatory Specialist permanently for a Medical Device manufacturer. Our client, a leading medical device company, is seeking a Regulatory Specialist with expertise in FDA regulations, MDR, and technical files. In this role, you will play a pivotal role in ensuring regulatory compliance and driving the success of their innovative product range. Here's a sneak peek into what your role will entail: - MDR Remediation: take ownership of 5-8 technical files and ensure they are remediated to meet the MDR. - Cross-Functional Collaboration: work closely with various teams to fill in any gaps in the tech file summary. Confidently communicating with individuals to ensure timelines are met. - Quality Assurance Support: You will act as support to the QA team on audits for product recalls or regulatory related issues, so a basic understanding of QA will serve you well in this role. To thrive in this role, you'll need: In-depth knowledge of FDA regulations and ISO13485. Strong communication skills and the ability to proactively engage with various teams across the organisation. 3 years of experience in regulatory affairs, with a passion for learning and growing within the field. Please apply with an up to date CV and I will be in touch if successful. Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.
Mar 26, 2024
Full time
If you've been looking for a company allowing you to work remotely, this is it. We are looking to hire a Regulatory Specialist permanently for a Medical Device manufacturer. Our client, a leading medical device company, is seeking a Regulatory Specialist with expertise in FDA regulations, MDR, and technical files. In this role, you will play a pivotal role in ensuring regulatory compliance and driving the success of their innovative product range. Here's a sneak peek into what your role will entail: - MDR Remediation: take ownership of 5-8 technical files and ensure they are remediated to meet the MDR. - Cross-Functional Collaboration: work closely with various teams to fill in any gaps in the tech file summary. Confidently communicating with individuals to ensure timelines are met. - Quality Assurance Support: You will act as support to the QA team on audits for product recalls or regulatory related issues, so a basic understanding of QA will serve you well in this role. To thrive in this role, you'll need: In-depth knowledge of FDA regulations and ISO13485. Strong communication skills and the ability to proactively engage with various teams across the organisation. 3 years of experience in regulatory affairs, with a passion for learning and growing within the field. Please apply with an up to date CV and I will be in touch if successful. Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.
Responsibilities : Development/Improvement activities: Serve as SME to support Site/Global projects. Proactively identifies scope for improvement or development based on knowledge of short to mid-term business needs. Leads and develops a strategy, plans and manages projects for method development or improvement as identified. Makes data supported decisions on project progression; uses technical expertise to overcome analytical issues. Documents project work as detailed lab book records or under technical protocols and reports as appropriate. Disseminates project findings/status updates at regular meetings/forums within Global AS&T. Represents as an interface between AS&T and key stakeholders (QC, MS&T, Regulatory Affairs). Operations Support: Participates in lab work-load planning with the wider team. Design work plans/projects with a compliance development mindset i.e., GMP adherence. Performs tests in accordance with established methods and properly documents test results. Provides guidance/mentorship/training to other lab staff as required. Evaluates performance of analytical instruments and equipment and recommends new acquisition or replacements initiatives. Authors/Reviewer protocols and reports for suitability studies and investigations to support testing and compliance issues, technical writing proficient. Ensures laboratory instruments are qualified, calibrated and properly maintained and documentation complies with cGMP standards. Assists and maintains standard operating procedures (SOPs), risk assessments and other quality documentation as required. Documents quality issues and performance measures for management review. Qualifications : Bachelor's degree in a relevant scientific discipline (Chemistry, Biochemistry.) MSc (d esirable ) PhD (d esirable ) A recognized expert in Analytical and Biological methods (CE, ELISA, SDS-PAGE) Experience of working in pharmaceuticals, particularly biologics is advantageous. Experience of assay development and validation essential. Assay lifecycle from proof of concept to registration and change management. Desirable to have experience of process or product characterization using a variety orthogonal method. Desirable to have people leader experience and or leading project teams. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our Benefits CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus. About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus . We want Seqirus to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus. Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus
Mar 25, 2024
Full time
Responsibilities : Development/Improvement activities: Serve as SME to support Site/Global projects. Proactively identifies scope for improvement or development based on knowledge of short to mid-term business needs. Leads and develops a strategy, plans and manages projects for method development or improvement as identified. Makes data supported decisions on project progression; uses technical expertise to overcome analytical issues. Documents project work as detailed lab book records or under technical protocols and reports as appropriate. Disseminates project findings/status updates at regular meetings/forums within Global AS&T. Represents as an interface between AS&T and key stakeholders (QC, MS&T, Regulatory Affairs). Operations Support: Participates in lab work-load planning with the wider team. Design work plans/projects with a compliance development mindset i.e., GMP adherence. Performs tests in accordance with established methods and properly documents test results. Provides guidance/mentorship/training to other lab staff as required. Evaluates performance of analytical instruments and equipment and recommends new acquisition or replacements initiatives. Authors/Reviewer protocols and reports for suitability studies and investigations to support testing and compliance issues, technical writing proficient. Ensures laboratory instruments are qualified, calibrated and properly maintained and documentation complies with cGMP standards. Assists and maintains standard operating procedures (SOPs), risk assessments and other quality documentation as required. Documents quality issues and performance measures for management review. Qualifications : Bachelor's degree in a relevant scientific discipline (Chemistry, Biochemistry.) MSc (d esirable ) PhD (d esirable ) A recognized expert in Analytical and Biological methods (CE, ELISA, SDS-PAGE) Experience of working in pharmaceuticals, particularly biologics is advantageous. Experience of assay development and validation essential. Assay lifecycle from proof of concept to registration and change management. Desirable to have experience of process or product characterization using a variety orthogonal method. Desirable to have people leader experience and or leading project teams. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our Benefits CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus. About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus . We want Seqirus to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus. Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus
Pod Talent are really excited to be working with an international food manufacturing business with renowned and loved consumer brands across the world. They are looking for a NPD Planning Lead (12 month FTC) to join their team in London and take part in the continued growth of an established and advanced business. You will be accountable for ensuring flawless execution of NPD launches, SKU changes and delists on time with excellent service and minimal waste; ensuring the right production/stock strategies are in place as well as driving continuous improvement plans within supply planning capability. This is a genuinely exciting opportunity to get behind the scenes with a business who no doubt produce some of the food on your table! A progressive, diverse, and well-established business who can offer excellent compensation and package, and the chance to grow your career long-term. Responsibilities As an NPD Planning Lead you will: Ensure 100% of NPD's/SKU changes can be launched on time with excellent service and minimal waste Provide planning input to scope development in areas such as schedule, cost, inventory impact, feasibility Influence the business's plants and ESC on MOQ's and production frequencies Own % NPD launch on time, % of critical gate timelines achieved, gate process adherence, CFR and Waste for product initiatives Requirements About you 3+ years of supply chain experience, ideally within planning (supply, demand, initiatives) and NPD Project management skills and continuous improvement mindset Proactive approach with strong communication skills Strongly analytical (Excel + SAP) Sounds good? Please apply or let me know at Pod Talent are independent specialist recruiters in the Supply Chain, Procurement, Logistics, Manufacturing and Technical space covering roles internationally from entry to board level. We recruit for roles including Supply Chain, Demand Planning, Inventory Management, Direct and Indirect Procurement, Category Management, Logistics, Distribution, Warehousing, Production, Packaging, NPD, Regulatory Affairs and Quality Assurance. Please visit our website for all of our vacancies.
Mar 24, 2024
Full time
Pod Talent are really excited to be working with an international food manufacturing business with renowned and loved consumer brands across the world. They are looking for a NPD Planning Lead (12 month FTC) to join their team in London and take part in the continued growth of an established and advanced business. You will be accountable for ensuring flawless execution of NPD launches, SKU changes and delists on time with excellent service and minimal waste; ensuring the right production/stock strategies are in place as well as driving continuous improvement plans within supply planning capability. This is a genuinely exciting opportunity to get behind the scenes with a business who no doubt produce some of the food on your table! A progressive, diverse, and well-established business who can offer excellent compensation and package, and the chance to grow your career long-term. Responsibilities As an NPD Planning Lead you will: Ensure 100% of NPD's/SKU changes can be launched on time with excellent service and minimal waste Provide planning input to scope development in areas such as schedule, cost, inventory impact, feasibility Influence the business's plants and ESC on MOQ's and production frequencies Own % NPD launch on time, % of critical gate timelines achieved, gate process adherence, CFR and Waste for product initiatives Requirements About you 3+ years of supply chain experience, ideally within planning (supply, demand, initiatives) and NPD Project management skills and continuous improvement mindset Proactive approach with strong communication skills Strongly analytical (Excel + SAP) Sounds good? Please apply or let me know at Pod Talent are independent specialist recruiters in the Supply Chain, Procurement, Logistics, Manufacturing and Technical space covering roles internationally from entry to board level. We recruit for roles including Supply Chain, Demand Planning, Inventory Management, Direct and Indirect Procurement, Category Management, Logistics, Distribution, Warehousing, Production, Packaging, NPD, Regulatory Affairs and Quality Assurance. Please visit our website for all of our vacancies.
A career in our Financial Services Tax practice, within Corporate Tax services, will provide you with the opportunity to help our clients meet their tax obligations while managing the impact tax has on their business. You'll advise clients on their local and overseas tax affairs, while acting as a strategic consultant related to business analysis, managing working capital, and profit sharing for partners. You'll also help organisations understand the pricing implications of goods and services between related parties, as well as providing advice on tax implications of deals. Our team helps our Financial Services clients navigate the frequently changing and complex national and international tax environment related to stringent capital requirements, management of operational tax risks, and tax implications of investing in different jurisdictions. You'll help our clients with their tax structuring while helping to address the challenges of the continuously changing tax world, both locally and globally. Our Financial Services Indirect Tax team is market leading, providing advisory, operational and compliance services to PwC's largest and most important clients. We advise across all aspects of indirect tax, with specialists in VAT, excise, stamp taxes and environmental taxes. Our team is fueled by curious minds who work together to provide innovative solutions to navigate challenges, both locally and globally. As part of the team you'll continue to build your tax technical skills as you work with a variety of clients across all business sectors, whilst at the same time have the opportunity to develop your operational consulting and technology skills as you support clients in how they deal with the day to day practicalities of meeting the requirements of an increasingly complex legal and regulatory landscape. As part of the team you will experience unparalleled opportunities to develop your career, build your skills and experience working on complex and challenging assignments. If you are ready to accelerate your career in indirect tax then this is the opportunity for you. We are keen to hear from anybody with an enthusiasm for Indirect Tax with Financial Services Experience The role You will work as an integral part of a team of problem solvers, helping our clients tackle their complex issues from strategy to execution. Responsibilities include but are not limited to: Building relationships with our clients and other internal (UK and global PwC network) teams Working alongside others in the Indirect Tax team and other PwC teams to win new clients and work Providing innovative solutions and advice aligned to our clients' commercial needs Delivery of the highest quality advice to clients Managing and helping to develop others in the team Working in multidisciplinary Indirect Tax teams (e.g. with customs, legal and systems specialists) Keeping up to date with indirect tax legislation and practical changes Supporting the creation of and working with cutting edge technology to solve client problems The opportunity to work with senior leaders in our indirect tax practice, who will invest in your development and provide you with access to business mentors to help maximise your potential Essential skills and experience: Excellent VAT technical and analytical skills Good communication skills, written and oral A commitment to team working A commitment to delivering excellent client service Strong project management skills and the ability to prioritise tasks Ability to apply good judgement, consult appropriately and manage risks Good self-organisational skills Resilience and ability to work to deadlines Ability to work flexibly and through virtual networks Ability to manage and support junior staff A strong interest and understanding of the benefits of technology and innovation Ambition and a strong desire to succeed ACA/CTA Qualification desirable
Mar 23, 2024
Full time
A career in our Financial Services Tax practice, within Corporate Tax services, will provide you with the opportunity to help our clients meet their tax obligations while managing the impact tax has on their business. You'll advise clients on their local and overseas tax affairs, while acting as a strategic consultant related to business analysis, managing working capital, and profit sharing for partners. You'll also help organisations understand the pricing implications of goods and services between related parties, as well as providing advice on tax implications of deals. Our team helps our Financial Services clients navigate the frequently changing and complex national and international tax environment related to stringent capital requirements, management of operational tax risks, and tax implications of investing in different jurisdictions. You'll help our clients with their tax structuring while helping to address the challenges of the continuously changing tax world, both locally and globally. Our Financial Services Indirect Tax team is market leading, providing advisory, operational and compliance services to PwC's largest and most important clients. We advise across all aspects of indirect tax, with specialists in VAT, excise, stamp taxes and environmental taxes. Our team is fueled by curious minds who work together to provide innovative solutions to navigate challenges, both locally and globally. As part of the team you'll continue to build your tax technical skills as you work with a variety of clients across all business sectors, whilst at the same time have the opportunity to develop your operational consulting and technology skills as you support clients in how they deal with the day to day practicalities of meeting the requirements of an increasingly complex legal and regulatory landscape. As part of the team you will experience unparalleled opportunities to develop your career, build your skills and experience working on complex and challenging assignments. If you are ready to accelerate your career in indirect tax then this is the opportunity for you. We are keen to hear from anybody with an enthusiasm for Indirect Tax with Financial Services Experience The role You will work as an integral part of a team of problem solvers, helping our clients tackle their complex issues from strategy to execution. Responsibilities include but are not limited to: Building relationships with our clients and other internal (UK and global PwC network) teams Working alongside others in the Indirect Tax team and other PwC teams to win new clients and work Providing innovative solutions and advice aligned to our clients' commercial needs Delivery of the highest quality advice to clients Managing and helping to develop others in the team Working in multidisciplinary Indirect Tax teams (e.g. with customs, legal and systems specialists) Keeping up to date with indirect tax legislation and practical changes Supporting the creation of and working with cutting edge technology to solve client problems The opportunity to work with senior leaders in our indirect tax practice, who will invest in your development and provide you with access to business mentors to help maximise your potential Essential skills and experience: Excellent VAT technical and analytical skills Good communication skills, written and oral A commitment to team working A commitment to delivering excellent client service Strong project management skills and the ability to prioritise tasks Ability to apply good judgement, consult appropriately and manage risks Good self-organisational skills Resilience and ability to work to deadlines Ability to work flexibly and through virtual networks Ability to manage and support junior staff A strong interest and understanding of the benefits of technology and innovation Ambition and a strong desire to succeed ACA/CTA Qualification desirable
An exciting opportunity for a German Speaking candidate with a background in Specifications and Artwork approval to join this highly successful business that provide labelling, consumer information and regulatory advice. OPPORTUNITY HIGHLIGHTS Fully remote role This role is for a fluent German Speaking candidate only. Fantastic benefits including: remote working, Enhanced company pension, Healthcare options, 25 days holiday etc THE REGULATORY AFFAIRS ADVISOR We are looking for an experienced Regulatory Affairs Advisor (Fluent in german) to join our client's team to check and approve specifications and artworks for their German speaking markets, for some new and exciting projects In this role you will be reviewing product information against regulation and customer policies, advising customers and their suppliers on how to get it right. You will be using your knowledge and experience to inquisitively question and challenge to ensure due diligence and compliance. You will be accountable for quality, accurate and timely risk-based advice, which enables our customers to launch products competitively and safely. Other key responsibilities will include: Formulation review Regulatory Adaptations Specification/pack copy review Artwork review Alignment Check (PLV/PAC/CTS/RSR) THE IDEAL CANDIDATE You will need to have experience working in a Specifications & Artwork approval or a Regulatory Affairs role within the Food Industry. We are also ideally looking for a Native German Speaker who understand food industry challenges and consumer trends in Germany. Other key attributes will include: Bilingual - Fluent in English and German (Essential) Degree or equivalent in Food Science/Food Law or in a related field. Practical experience of using specification or artwork packages Experience of working in a technical/regulatory role, or in a related field If this Regulatory Affairs Advisor role is of interest and you would like to investigate this further, apply TODAY Kandhu Recruitment are specialist recruiters within the Food, Drink and FMCG Sector "Kandhu Recruitment will consider all applications based on each candidate's suitability to the role or similar roles within the Food Sector and if we feel you are a relevant candidate we will process your application by adding you to our secure recruitment database and then contacting you to progress job opportunities further. We do not contact unsuitable applicants." Kandhu GDPR & Privacy Policy Statement Kandhu has fully implemented GDPR & Privacy Policies across its business and a copy of our Privacy Policy can be found by visiting our website. By applying for this role Kandhu will add your details to our database - assuming you have the right level of experience for the roles you apply for, after which we will be in touch.
Mar 23, 2024
Full time
An exciting opportunity for a German Speaking candidate with a background in Specifications and Artwork approval to join this highly successful business that provide labelling, consumer information and regulatory advice. OPPORTUNITY HIGHLIGHTS Fully remote role This role is for a fluent German Speaking candidate only. Fantastic benefits including: remote working, Enhanced company pension, Healthcare options, 25 days holiday etc THE REGULATORY AFFAIRS ADVISOR We are looking for an experienced Regulatory Affairs Advisor (Fluent in german) to join our client's team to check and approve specifications and artworks for their German speaking markets, for some new and exciting projects In this role you will be reviewing product information against regulation and customer policies, advising customers and their suppliers on how to get it right. You will be using your knowledge and experience to inquisitively question and challenge to ensure due diligence and compliance. You will be accountable for quality, accurate and timely risk-based advice, which enables our customers to launch products competitively and safely. Other key responsibilities will include: Formulation review Regulatory Adaptations Specification/pack copy review Artwork review Alignment Check (PLV/PAC/CTS/RSR) THE IDEAL CANDIDATE You will need to have experience working in a Specifications & Artwork approval or a Regulatory Affairs role within the Food Industry. We are also ideally looking for a Native German Speaker who understand food industry challenges and consumer trends in Germany. Other key attributes will include: Bilingual - Fluent in English and German (Essential) Degree or equivalent in Food Science/Food Law or in a related field. Practical experience of using specification or artwork packages Experience of working in a technical/regulatory role, or in a related field If this Regulatory Affairs Advisor role is of interest and you would like to investigate this further, apply TODAY Kandhu Recruitment are specialist recruiters within the Food, Drink and FMCG Sector "Kandhu Recruitment will consider all applications based on each candidate's suitability to the role or similar roles within the Food Sector and if we feel you are a relevant candidate we will process your application by adding you to our secure recruitment database and then contacting you to progress job opportunities further. We do not contact unsuitable applicants." Kandhu GDPR & Privacy Policy Statement Kandhu has fully implemented GDPR & Privacy Policies across its business and a copy of our Privacy Policy can be found by visiting our website. By applying for this role Kandhu will add your details to our database - assuming you have the right level of experience for the roles you apply for, after which we will be in touch.
Private Wealth Tax Director page is loaded Private Wealth Tax Director Apply locations London time type Full time posted on Posted 11 Days Ago job requisition id R14418 Job Description Ideas People Trust We're BDO. An accountancy and business advisory firm, providing the advice and solutions entrepreneurial organisations need to navigate today's changing world. We work with the companies that are Britain's economic engine - ambitious, entrepreneurially-spirited and high growth businesses that fuel the economy - and directly advise the owners and management teams that lead them. We'll broaden your horizons Working, achieving, and thriving together, our Tax team move with every challenge. Friendly, driven and diverse, they service our clients across the country and around the world. By providing expertise in many different specialist areas of tax, they collaborate across BDO to deliver wider business solutions. From meeting clients' evolving business needs to managing changes to legislation, there are always fresh challenges to face in the Tax team. If you're after a career that will keep you on your toes, we'll give you the autonomy to drive your career forward. Tax is a dynamic, ever-changing industry. As our clients' needs and the regulatory environment evolve, you'll encounter new problems to solve and new opportunities for growth. Whether it's advising clients on high-profile specialisms like Corporation Tax or leading the implementation of intelligent technology solutions, you'll enjoy variety as well as stretch in your role. BDO supports all kinds of different businesses in different sectors across the UK and around the world. You'll be providing Tax Advisory services to start-ups and scale-ups, to private businesses and FTSE listed multinationals. Each of our clients has different needs and in applying your expertise in different contexts, you'll develop your skills and gain valuable experience that will serve you throughout your career. We'll help you succeed Leading organisations trust us because of the quality of our advice. That quality grows from a thorough understanding of their business, and that understanding comes from working closely with them and building long-lasting relationships. You'll be someone who is both comfortable working proactively and managing your own tasks, as well as confident collaborating with others and communicating regularly with senior managers, directors, and BDO's partners to help businesses effectively. You'll be encouraged to identify and draw attention to opportunities for enhancing our delivery and providing additional services to organisations we work with. Our rapidly growing Private Client Team manage funds, businesses and trusts of individuals, families and entrepreneurs. Alongside solving a constantly evolving range of technical challenges, working in this team means building strong relationships with individuals so you can become their trusted advisor and oversee their tax affairs in line with what they want to achieve as an individual or business. We've established a strong global network that is recognised as a leader especially in looking after entrepreneurs and owner-managed businesses. You'll need excellent people skills and strong technical ability as you visit clients across the world. In return, you'll have unparalleled access to partners and opportunities to develop your career in many different directions as you work across a truly diverse portfolio of global clients. We're looking for someone with: Maintain an in depth, up to date, knowledge of relevant aspects of Private Client taxation. Acknowledged as an expert in their specialist field and able to deal with complex tax issues. Educated to degree level; and/or CTA and/or ACA qualified or equivalent. Demonstrable appropriate post qualified experience. You'll be able to be yourself; we'll recognise and value you for who you are and celebrate and reward your contributions to the business. We're committed to agile working, and we offer every colleague the opportunity to work in ways that suit you, your teams, and the task at hand. At BDO, we'll help you achieve your personal goals and career ambitions, and we have programmes, resources, and frameworks that provide clarity and structure around career development. You'll be able to be yourself; we'll recognise and value you for who you are and celebrate and reward your contributions to the business. We're committed to agile working, and we offer every colleague the opportunity to work in ways that suit you, your teams, and the task at hand. At BDO, we'll help you achieve your personal goals and career ambitions, and we have programmes, resources, and frameworks that provide clarity and structure around career development. We're in it together Mutual support and respect is one of BDO's core values and we're proud of our distinctive, people-centred culture. From informal success conversations to formal mentoring and coaching, we'll support you at every stage in your career, whatever your personal and professional needs. Our agile working framework helps us stay connected, bringing teams together where and when it counts so they can share ideas and help one another. At BDO, you'll always have access to the people and resources you need to do your best work. We know that collaboration is the key to creating value for the companies we work with and satisfying experiences for our colleagues, so we've invested in state-of-the-art collaboration spaces in our offices. BDO's people represent a wealth of knowledge and expertise, and we'll encourage you to build your network, work alongside others, and share your skills and experiences. With a range of multidisciplinary events and dedicated resources, you'll never stop learning at BDO. We're looking forward to the future At BDO, we help entrepreneurial businesses to succeed, fuelling the UK economy. Our success is powered by our people, which is why we're always finding new ways to invest in you. Across the UK thousands of unique minds continue to come together to help companies we work with to achieve their ambitions We've got a clear purpose, and we're confident in our future, because we're adapting and evolving to build on our strengths, ensuring we continue to find the right combination of global reach, integrity and expertise. We shape the future together with openness and clarity, because we believe in empowering people to think creatively about how we can do things better. Similar Jobs (1) Private Wealth Tax Director locations London time type Full time posted on Posted 11 Days Ago BDO UK provides tax, audit and assurance, advisory and business outsourcing service s. Our clients are Britain's economic engine - ambitious, entrepreneurially-spirited and high growth businesses that fuel the economy - and the owners and management teams that lead them. Our partners and staff are specialists in their fields and have a proactive, flexible approach to helping clients overcoming the challenges they face. We aim to be as innovative and entrepreneurial as our clients. Our approach and expertise are what help us deliver exceptional client service. 95% of our clients would recommend us. We operate from 17 locations across the UK, covering all major business centres. We employ 7,500 people who are encouraged to bring their best selves to work; taking responsibility for their work and their relationships with clients. All our people share core values that underpin both our culture and the value that we bring to our clients. Our values are also reflected in continued focus on ESG. Our firm is distinctive and we want to preserve and build on the strengths of our culture and the characteristics that make us both successful and different. We look for people from all kinds of backgrounds who share these same qualities. BDO LLP is a key member of the BDO global network of public accounting, tax and advisory firms. The firms have representation in 16 4 countries, with 111,300 people working out of over 1,803 offices worldwide. That's BDO and we are proud to be part of it. Being part of an integrated network of firms across the world provides us with myriad opportunities for success.
Mar 23, 2024
Full time
Private Wealth Tax Director page is loaded Private Wealth Tax Director Apply locations London time type Full time posted on Posted 11 Days Ago job requisition id R14418 Job Description Ideas People Trust We're BDO. An accountancy and business advisory firm, providing the advice and solutions entrepreneurial organisations need to navigate today's changing world. We work with the companies that are Britain's economic engine - ambitious, entrepreneurially-spirited and high growth businesses that fuel the economy - and directly advise the owners and management teams that lead them. We'll broaden your horizons Working, achieving, and thriving together, our Tax team move with every challenge. Friendly, driven and diverse, they service our clients across the country and around the world. By providing expertise in many different specialist areas of tax, they collaborate across BDO to deliver wider business solutions. From meeting clients' evolving business needs to managing changes to legislation, there are always fresh challenges to face in the Tax team. If you're after a career that will keep you on your toes, we'll give you the autonomy to drive your career forward. Tax is a dynamic, ever-changing industry. As our clients' needs and the regulatory environment evolve, you'll encounter new problems to solve and new opportunities for growth. Whether it's advising clients on high-profile specialisms like Corporation Tax or leading the implementation of intelligent technology solutions, you'll enjoy variety as well as stretch in your role. BDO supports all kinds of different businesses in different sectors across the UK and around the world. You'll be providing Tax Advisory services to start-ups and scale-ups, to private businesses and FTSE listed multinationals. Each of our clients has different needs and in applying your expertise in different contexts, you'll develop your skills and gain valuable experience that will serve you throughout your career. We'll help you succeed Leading organisations trust us because of the quality of our advice. That quality grows from a thorough understanding of their business, and that understanding comes from working closely with them and building long-lasting relationships. You'll be someone who is both comfortable working proactively and managing your own tasks, as well as confident collaborating with others and communicating regularly with senior managers, directors, and BDO's partners to help businesses effectively. You'll be encouraged to identify and draw attention to opportunities for enhancing our delivery and providing additional services to organisations we work with. Our rapidly growing Private Client Team manage funds, businesses and trusts of individuals, families and entrepreneurs. Alongside solving a constantly evolving range of technical challenges, working in this team means building strong relationships with individuals so you can become their trusted advisor and oversee their tax affairs in line with what they want to achieve as an individual or business. We've established a strong global network that is recognised as a leader especially in looking after entrepreneurs and owner-managed businesses. You'll need excellent people skills and strong technical ability as you visit clients across the world. In return, you'll have unparalleled access to partners and opportunities to develop your career in many different directions as you work across a truly diverse portfolio of global clients. We're looking for someone with: Maintain an in depth, up to date, knowledge of relevant aspects of Private Client taxation. Acknowledged as an expert in their specialist field and able to deal with complex tax issues. Educated to degree level; and/or CTA and/or ACA qualified or equivalent. Demonstrable appropriate post qualified experience. You'll be able to be yourself; we'll recognise and value you for who you are and celebrate and reward your contributions to the business. We're committed to agile working, and we offer every colleague the opportunity to work in ways that suit you, your teams, and the task at hand. At BDO, we'll help you achieve your personal goals and career ambitions, and we have programmes, resources, and frameworks that provide clarity and structure around career development. You'll be able to be yourself; we'll recognise and value you for who you are and celebrate and reward your contributions to the business. We're committed to agile working, and we offer every colleague the opportunity to work in ways that suit you, your teams, and the task at hand. At BDO, we'll help you achieve your personal goals and career ambitions, and we have programmes, resources, and frameworks that provide clarity and structure around career development. We're in it together Mutual support and respect is one of BDO's core values and we're proud of our distinctive, people-centred culture. From informal success conversations to formal mentoring and coaching, we'll support you at every stage in your career, whatever your personal and professional needs. Our agile working framework helps us stay connected, bringing teams together where and when it counts so they can share ideas and help one another. At BDO, you'll always have access to the people and resources you need to do your best work. We know that collaboration is the key to creating value for the companies we work with and satisfying experiences for our colleagues, so we've invested in state-of-the-art collaboration spaces in our offices. BDO's people represent a wealth of knowledge and expertise, and we'll encourage you to build your network, work alongside others, and share your skills and experiences. With a range of multidisciplinary events and dedicated resources, you'll never stop learning at BDO. We're looking forward to the future At BDO, we help entrepreneurial businesses to succeed, fuelling the UK economy. Our success is powered by our people, which is why we're always finding new ways to invest in you. Across the UK thousands of unique minds continue to come together to help companies we work with to achieve their ambitions We've got a clear purpose, and we're confident in our future, because we're adapting and evolving to build on our strengths, ensuring we continue to find the right combination of global reach, integrity and expertise. We shape the future together with openness and clarity, because we believe in empowering people to think creatively about how we can do things better. Similar Jobs (1) Private Wealth Tax Director locations London time type Full time posted on Posted 11 Days Ago BDO UK provides tax, audit and assurance, advisory and business outsourcing service s. Our clients are Britain's economic engine - ambitious, entrepreneurially-spirited and high growth businesses that fuel the economy - and the owners and management teams that lead them. Our partners and staff are specialists in their fields and have a proactive, flexible approach to helping clients overcoming the challenges they face. We aim to be as innovative and entrepreneurial as our clients. Our approach and expertise are what help us deliver exceptional client service. 95% of our clients would recommend us. We operate from 17 locations across the UK, covering all major business centres. We employ 7,500 people who are encouraged to bring their best selves to work; taking responsibility for their work and their relationships with clients. All our people share core values that underpin both our culture and the value that we bring to our clients. Our values are also reflected in continued focus on ESG. Our firm is distinctive and we want to preserve and build on the strengths of our culture and the characteristics that make us both successful and different. We look for people from all kinds of backgrounds who share these same qualities. BDO LLP is a key member of the BDO global network of public accounting, tax and advisory firms. The firms have representation in 16 4 countries, with 111,300 people working out of over 1,803 offices worldwide. That's BDO and we are proud to be part of it. Being part of an integrated network of firms across the world provides us with myriad opportunities for success.
Design Control and Regulatory Systems Engineer Walsall Opportunity: Do you have experience in design control and risk management for medical device products? Have you created Design History Files and Technical Files for medical devices? Have you created documentation for submission to FDA for 510(K) approvals? Want to work for an innovative medical device manufacturing company? If yes then this is the role for you. Your role as a Design Control and Regulatory Systems Engineer will be based working on site at Walsall supporting the R&D team on design controls, risk management and ensuring the medical device product development activities are in compliance with Quality and Regulatory standards. Key responsibilities and duties include: Working with the R&D team to identify the work products required based on the product scope (NPI and Design Change). Guiding the R&D team and creating the required work products (process and product) ensuring compliance to QMS. Creating and maintaining the Design History Files for medical device products. Working with the team on work products required for 60601 testing. Creating documentation for submission to FDA for 510(K) approvals. Creating and updating product technical files in compliance with EU and relevant countries regulatory requirements. This is a full time permanent job opportunity based in Walsall paying an excellent salary of £40,000 - £47,000 per annum and great benefits such as 23 days holidays plus bank holidays on top, Insights Bonus scheme, cycle to work scheme, Life insurance and much more. Skills: To apply for the role of Design Control and Regulatory Systems Engineer you will have the following: Bachelor s Degree in Scientific or Engineering discipline. Experience in quality engineering and regulatory affairs in a medical device industry. Working knowledge of Medical Products Quality Management System. Experience in creating documentation for regulatory compliance (for example: FDA, ISO, CE, etc). Experience with design reviews and design controls. Working knowledge of CE certification requirements and transition from EU MDD to EU MDR. How to Apply: To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on the Quality Start website. If this sounds like the role for you or a colleague then please don t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information. For a list of our current vacancies, please visit the Quality Start website. If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role. Quality Start are acting as a specialist recruitment consultancy for this role.
Mar 23, 2024
Full time
Design Control and Regulatory Systems Engineer Walsall Opportunity: Do you have experience in design control and risk management for medical device products? Have you created Design History Files and Technical Files for medical devices? Have you created documentation for submission to FDA for 510(K) approvals? Want to work for an innovative medical device manufacturing company? If yes then this is the role for you. Your role as a Design Control and Regulatory Systems Engineer will be based working on site at Walsall supporting the R&D team on design controls, risk management and ensuring the medical device product development activities are in compliance with Quality and Regulatory standards. Key responsibilities and duties include: Working with the R&D team to identify the work products required based on the product scope (NPI and Design Change). Guiding the R&D team and creating the required work products (process and product) ensuring compliance to QMS. Creating and maintaining the Design History Files for medical device products. Working with the team on work products required for 60601 testing. Creating documentation for submission to FDA for 510(K) approvals. Creating and updating product technical files in compliance with EU and relevant countries regulatory requirements. This is a full time permanent job opportunity based in Walsall paying an excellent salary of £40,000 - £47,000 per annum and great benefits such as 23 days holidays plus bank holidays on top, Insights Bonus scheme, cycle to work scheme, Life insurance and much more. Skills: To apply for the role of Design Control and Regulatory Systems Engineer you will have the following: Bachelor s Degree in Scientific or Engineering discipline. Experience in quality engineering and regulatory affairs in a medical device industry. Working knowledge of Medical Products Quality Management System. Experience in creating documentation for regulatory compliance (for example: FDA, ISO, CE, etc). Experience with design reviews and design controls. Working knowledge of CE certification requirements and transition from EU MDD to EU MDR. How to Apply: To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on the Quality Start website. If this sounds like the role for you or a colleague then please don t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information. For a list of our current vacancies, please visit the Quality Start website. If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role. Quality Start are acting as a specialist recruitment consultancy for this role.
Product Surveillance Reporting Analyst 12 months 17.96 p/h Marlow - hybrid (3 days on site) SRG are partnered with a pharmaceutical organisation who are seeking a Product Surveillance Reporting Analyst to join their team in Marlow. Purpose of the role The Reporting Specialist is responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. Responsibilities: Decision maker for all reportability decisions Lead for all vigilance reporting, including local and global submissions Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate Ensures that relevant stakeholders have visibility to the reporting and where they are in the process Manages regular reporting needs and external requests (i.e. from the FDA etc.) Manage the timeline for end-to-end reporting Owns translation services for reporting Qualifications/experience: Bachelor's Degree required, preferably in the life sciences, pharmacy, nursing, or other scientific background 5+ years of work experience in a cGMP related industry or in a clinical setting (preferred) Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products. Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred. Solid written/verbal communication and organizational skills. Knowledge and application of computer systems for word processing and complaint management. Ability to work with cross-functional teams and to interact effectively with peers, management, and customers. Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
Mar 23, 2024
Seasonal
Product Surveillance Reporting Analyst 12 months 17.96 p/h Marlow - hybrid (3 days on site) SRG are partnered with a pharmaceutical organisation who are seeking a Product Surveillance Reporting Analyst to join their team in Marlow. Purpose of the role The Reporting Specialist is responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. Responsibilities: Decision maker for all reportability decisions Lead for all vigilance reporting, including local and global submissions Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate Ensures that relevant stakeholders have visibility to the reporting and where they are in the process Manages regular reporting needs and external requests (i.e. from the FDA etc.) Manage the timeline for end-to-end reporting Owns translation services for reporting Qualifications/experience: Bachelor's Degree required, preferably in the life sciences, pharmacy, nursing, or other scientific background 5+ years of work experience in a cGMP related industry or in a clinical setting (preferred) Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products. Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred. Solid written/verbal communication and organizational skills. Knowledge and application of computer systems for word processing and complaint management. Ability to work with cross-functional teams and to interact effectively with peers, management, and customers. Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
The Role The role is within a growing and dynamic centralised Insolvency Delivery Team ("IDT") supporting all Teneo offices on all insolvency assignments. The role will be within sub-teams with each team dealing with c.50 cases and managing the day to day aspects of all new and existing insolvency cases. The Financial Advisory Team at Teneo Teneo's global Financial Advisory business advises corporates, creditors and other financial stakeholders in situations of financial stress and distress. No two situations are the same. Our advice and approach is tailored to each situation and each client. At Teneo, we believe such occurrences present new opportunities for our clients. Opportunities to restore value, raise new capital, pivot in a new direction and ultimately, identify certainty amidst chaos. Teneo partners with clients to find viable opportunities that will protect and enhance value and help them to build strategies that will most benefit their business and/or investment goals. Integrating the disciplines of Financial Advisory, financial advisory, management consulting, investor relations, strategic communications, government affairs, risk analysis and talent advisory, Teneo's global Financial Advisory team guides companies and their stakeholders through periods of uncertainty and stress. We help address the challenges a business faces, whether that is targeted performance improvement to Financial Advisory, or delivering a route to recover value, our focus is delivering certainty from uncertainty Key Responsibilities As an Insolvency Case Administrator, the primary nature of work that you will get involved with will likely include: All day to day case administrator responsibilities including: Supporting case managers and supervisors with case strategy and delivering case strategy; Completing statutory diary lines, compliance returns, case reviews etc.; Assisting with trading and processing receipts and payments; Drafting letters and statutory documents; Preparing progress reports for creditors including receipts and payment accounts and estimated outcome statements; Drafting reports to secured creditors where relevant; Other exercises will include: Responding to creditors queries and answering correspondence; Preparing and drafting CDDA submissions; Agreeing creditor claims and calculating creditor distributions; and Preparing receipt and expenses vouchers and journals. Supervising the work of secondees from other departments. Working with our Joint Venture team to complete tasks. Attending site & providing ongoing site support as the local office teams may require. Liaising with internal stakeholders (IPs and senior local office team staff) to provide updates on case progression matters and to assist more senior members of the IDT with planning for the delivery of new work. Ensuring best practice/firm/regulatory requirements are adhered to and that the firm's commitment to quality is reflected in all written output for creditors/other external stakeholders. Key Skills & Experience Corporate insolvency experience gained within the restructuring department of a firm or in a specialist insolvency practice, and in particular experience of managing tasks across a case load and using a case management system (e.g. IPS). A good understanding of key statutory requirements through the lifecycle of different corporate insolvency procedures. 'Qualified by experience' and/or holding relevant professional qualifications such as ATT, CPI etc. Strong risk awareness, with the knowledge/confidence to escalate risk issues appropriately. Excellent communication and interpersonal skills, as you would be dealing with all kinds of internal and external stakeholders. Experience in delegating tasks and reviewing the work of more junior staff. Experienced in using Word, Excel and Power Point. A strong and flexible work ethic. A confident and enthusiastic team player. What can we offer you? New joiners are supported by an induction programme. As well as this we offer a whole host of benefits and reward including; Market-leading Salary 25 days holiday Discretionary Bonus Scheme Company Pension Scheme Extensive investment in personal development & learning Enhanced maternity and paternity leave (depending on length of service) and shared parental leave Private medical insurance Life assurance Group income protection Cycle to work schemes Regular social, cultural and charitable activities About Teneo Teneo advises business leaders, enabling them to achieve goals faster and at lower cost by earning trust, navigating disruption and removing barriers. We are built to help businesses succeed in a world no longer defined by boundaries and disciplines. Working exclusively with the CEOs and senior executives of the world's leading companies, Teneo provides strategic counsel across their full range of key objectives and issues. Our clients include a significant number of the FTSE 100 and Fortune 100, as well as other global public and private corporations. We're an ambitious, global consultancy which allows candidates unmatched opportunities to develop and work with inspiring, motivated people. Our teams bring together the disciplines of strategic communications, investor relations, restructuring, management consulting, physical & cyber risk, financial advisory, corporate governance advisory, ESG, DE&I, political & policy risk, and talent advisory, to solve for the most complex business challenges and opportunities. We aim to make companies and institutions stronger and more valuable. We are capable of advising at the most senior levels across the world's leading businesses and organisations and we're proud to work with some of the strongest brands in the world. Across the globe, Teneo employs more than 1,200 people, offering global reach from a light infrastructure, built out of regional hubs. Our culture is critical to our success. We have a flat management structure with an open and supportive office atmosphere. To support progression and learning, we foster a supportive environment with a focus on mental health and wellbeing as well as adopting an inclusive environment that allows all employees to flourish. We recognise that diversity is essential for our business and encourage applicants from all backgrounds. At Teneo, we have fully embraced hybrid working and redefined the way we work such that it facilitates collaboration, optimises productivity and promotes the health and wellbeing of our people. We are also happy to discuss other forms of flexible working so please let us know if this is something you would like to discuss.
Sep 23, 2022
Full time
The Role The role is within a growing and dynamic centralised Insolvency Delivery Team ("IDT") supporting all Teneo offices on all insolvency assignments. The role will be within sub-teams with each team dealing with c.50 cases and managing the day to day aspects of all new and existing insolvency cases. The Financial Advisory Team at Teneo Teneo's global Financial Advisory business advises corporates, creditors and other financial stakeholders in situations of financial stress and distress. No two situations are the same. Our advice and approach is tailored to each situation and each client. At Teneo, we believe such occurrences present new opportunities for our clients. Opportunities to restore value, raise new capital, pivot in a new direction and ultimately, identify certainty amidst chaos. Teneo partners with clients to find viable opportunities that will protect and enhance value and help them to build strategies that will most benefit their business and/or investment goals. Integrating the disciplines of Financial Advisory, financial advisory, management consulting, investor relations, strategic communications, government affairs, risk analysis and talent advisory, Teneo's global Financial Advisory team guides companies and their stakeholders through periods of uncertainty and stress. We help address the challenges a business faces, whether that is targeted performance improvement to Financial Advisory, or delivering a route to recover value, our focus is delivering certainty from uncertainty Key Responsibilities As an Insolvency Case Administrator, the primary nature of work that you will get involved with will likely include: All day to day case administrator responsibilities including: Supporting case managers and supervisors with case strategy and delivering case strategy; Completing statutory diary lines, compliance returns, case reviews etc.; Assisting with trading and processing receipts and payments; Drafting letters and statutory documents; Preparing progress reports for creditors including receipts and payment accounts and estimated outcome statements; Drafting reports to secured creditors where relevant; Other exercises will include: Responding to creditors queries and answering correspondence; Preparing and drafting CDDA submissions; Agreeing creditor claims and calculating creditor distributions; and Preparing receipt and expenses vouchers and journals. Supervising the work of secondees from other departments. Working with our Joint Venture team to complete tasks. Attending site & providing ongoing site support as the local office teams may require. Liaising with internal stakeholders (IPs and senior local office team staff) to provide updates on case progression matters and to assist more senior members of the IDT with planning for the delivery of new work. Ensuring best practice/firm/regulatory requirements are adhered to and that the firm's commitment to quality is reflected in all written output for creditors/other external stakeholders. Key Skills & Experience Corporate insolvency experience gained within the restructuring department of a firm or in a specialist insolvency practice, and in particular experience of managing tasks across a case load and using a case management system (e.g. IPS). A good understanding of key statutory requirements through the lifecycle of different corporate insolvency procedures. 'Qualified by experience' and/or holding relevant professional qualifications such as ATT, CPI etc. Strong risk awareness, with the knowledge/confidence to escalate risk issues appropriately. Excellent communication and interpersonal skills, as you would be dealing with all kinds of internal and external stakeholders. Experience in delegating tasks and reviewing the work of more junior staff. Experienced in using Word, Excel and Power Point. A strong and flexible work ethic. A confident and enthusiastic team player. What can we offer you? New joiners are supported by an induction programme. As well as this we offer a whole host of benefits and reward including; Market-leading Salary 25 days holiday Discretionary Bonus Scheme Company Pension Scheme Extensive investment in personal development & learning Enhanced maternity and paternity leave (depending on length of service) and shared parental leave Private medical insurance Life assurance Group income protection Cycle to work schemes Regular social, cultural and charitable activities About Teneo Teneo advises business leaders, enabling them to achieve goals faster and at lower cost by earning trust, navigating disruption and removing barriers. We are built to help businesses succeed in a world no longer defined by boundaries and disciplines. Working exclusively with the CEOs and senior executives of the world's leading companies, Teneo provides strategic counsel across their full range of key objectives and issues. Our clients include a significant number of the FTSE 100 and Fortune 100, as well as other global public and private corporations. We're an ambitious, global consultancy which allows candidates unmatched opportunities to develop and work with inspiring, motivated people. Our teams bring together the disciplines of strategic communications, investor relations, restructuring, management consulting, physical & cyber risk, financial advisory, corporate governance advisory, ESG, DE&I, political & policy risk, and talent advisory, to solve for the most complex business challenges and opportunities. We aim to make companies and institutions stronger and more valuable. We are capable of advising at the most senior levels across the world's leading businesses and organisations and we're proud to work with some of the strongest brands in the world. Across the globe, Teneo employs more than 1,200 people, offering global reach from a light infrastructure, built out of regional hubs. Our culture is critical to our success. We have a flat management structure with an open and supportive office atmosphere. To support progression and learning, we foster a supportive environment with a focus on mental health and wellbeing as well as adopting an inclusive environment that allows all employees to flourish. We recognise that diversity is essential for our business and encourage applicants from all backgrounds. At Teneo, we have fully embraced hybrid working and redefined the way we work such that it facilitates collaboration, optimises productivity and promotes the health and wellbeing of our people. We are also happy to discuss other forms of flexible working so please let us know if this is something you would like to discuss.
About the job Summary Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. Would you like to be part of a vibrant group focused on the development and assessment of medical countermeasures which will keep our Armed Forces safe? Can you help make a difference to the UK's safety and security by applying your regulatory and scientific knowledge in this critical area? Are you keen to seek new challenges and work collaboratively with colleagues and partners across the world to deliver solutions? The work of the Toxicology, Trauma and Medicine Group within the Chemical, Biological and Radiological (CBR) Division is aimed at understanding and mitigating the lethal and incapacitating effects of various chemical and biological insults on the human body. Suitable medical countermeasures (small molecule drugs or biologicals) are identified within the research space, with successful candidate products taken forward into the Advanced Development Programme (ADP) to work towards a MAA. Candidate pharmaceutical products which progress to the Advanced Development Programme are rigorously tested to ensure they meet the quality, safety and efficacy standards required for licensure by the regulatory authorities. The research and development outcomes may inform a range of strategic and policy decisions across MOD and wider government. We are seeking a Pharmaceutical Regulatory Affairs Specialist to join the Advanced Development Programme (ADP) team. You will join a small, busy, multi-disciplinary team comprising of subject matter experts, to deliver safe and efficacious medical countermeasure products licensed by the regulatory authorities. The primary focus for the successful candidate will be a range of regulatory activities across the lifecycle of the Dstl pharmaceutical product portfolio, which includes a diverse range of products in development. Dstl recognises the importance of diversity and inclusion as people from diverse backgrounds bring fresh ideas. We are committed to building an inclusive working environment in which each employee fulfils their potential and maximises their contribution. We particularly welcome female and ethnic minority applicants and those from the LGBTQI community, as they are under-represented within Dstl at these levels. Job description In this role you will: Prepare and drive regulatory development plans for each product to ensure seamless transition between development phases Prepare/contribute to TPPs, IBs and IMPDs Prepare/manage CTAs and related supporting activities Ensure robust regulatory plans are established and followed in order to support future pharmaceutical licensing applications Work collaboratively across interdisciplinary teams to ensure robust studies are planned, carried out to the required regulatory standards and reported appropriately Provide robust and reliable regulatory advice to MOD stakeholders to enable informed decision making Exercise good judgement to reach evidence-based decisions and be confident and clear in presenting your ideas and work to a variety of technical and non-technical audiences Develop regulatory documentation and make timely submissions to regulatory authorities Support the production of marketing authorisation applications (externally delivered) Manage and conduct interactions with external regulatory authorities and ensure positive and trusted relationships are developed. Assist in building electronic document structures to aid future electronic CTD compilation Maintain currency in regulatory affairs regulations and requirements affecting pharmaceutical product development activities at Dstl Promote and raise the importance of regulatory affairs issues within the organisation and amongst stakeholders Maintain and communicate regulatory intelligence. Work effectively in a team Organise your time and be able to prioritise activities across a number of diverse activities Work safely in accordance with Dstl policies and procedures Responsibilities We are looking for an individual who has a significant level of experience applying expert regulatory knowledge to the pharmaceutical development lifecycle to join the ADP team. You will have prior experience in applying regulatory legislation and will have had previous interactions with the regulatory authorities, especially the MHRA. The successful candidate will work across teams, scientists and project managers to enable delivery of the projects. Your responsibilities will include driving the regulatory requirements, decisions and actions, in support of marketing authorisation applications (MAAs) for medical countermeasures. You will be required to engage at all levels within the organisation and externally with the MOD and other organisations, including regulatory authorities. You will have: Extensive experience of applying expert regulatory knowledge to the pharmaceutical development lifecycle Experience in a pharmaceutical company or CRO A good working knowledge of all current regulatory guidelines and regulations Strong understanding of CMC requirements Experience of constructing regulatory plans/strategies for pharmaceutical development projects Experience of contributing to/preparing Target Product Profiles (TPPs), Investigator's Brochures (IBs) and Investigational Medicinal Product Dossiers (IMPDs) Experience of preparing/managing Clinical Trial Applications (CTAs) Experience of interacting with regulatory authorities At least 3 years of regulatory affairs experience in pharmaceutical development A proven track record of working collaboratively within teams The ability to organise, plan and implement projects to deadlines Strong written and verbal communication skills A commitment to undertake continuing professional development throughout their career. Essential Skills and Experience You will have extensive experience of regulatory affairs experience in pharmaceutical development (pharmaceutical company or CRO) You will have a good working knowledge of current regulatory guidelines and regulations You will have a good working knowledge of the pharmaceutical development lifecycle You will have good working knowledge of the clinical trials regulations You will have demonstrable experience of contributing to/preparing TPPs, IBs and IMPDs You will have demonstrable experience of preparing and/or managing CTAs You will have demonstrable experience of interactions with regulatory authorities You will have the ability to work methodically with good attention to detail You will have good IT skills. Leadership As a leader in Defence you will help shape, role model and bring to life the 'One Defence' mindset that will enable us to deliver our vision and strategic objectives. Your leadership style must be inspiring, confident and empowering. Working at every level of our organisation to break down silos, unite teams and create a culture that is trusting, collaborative, innovative, diverse and inclusive. Enabling us to deliver with pace and agility through the skills, commitment and empowerment of our employees and military colleagues. Important Information Our work in defence, security and intelligence requires our employees to be UK Nationals who are able to gain a high level of security clearance to undertake the projects we are involved in to protect us from security threats. For this reason, only UK Nationals will be able to apply for this role. If you are an international or dual-national candidate, and you think you have the skills we need, please consider applying to any of our government, security or defence partners. This role will require full UK security clearance and you should have resided in the UK for the past 5 years. For some roles Developed Vetting will also be required, in this case you should have resided in the UK for the past 10 years. Behaviours We'll assess you against these behaviours during the selection process: Making Effective Decisions Working Together Delivering at Pace Leadership
Sep 23, 2022
Full time
About the job Summary Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. Would you like to be part of a vibrant group focused on the development and assessment of medical countermeasures which will keep our Armed Forces safe? Can you help make a difference to the UK's safety and security by applying your regulatory and scientific knowledge in this critical area? Are you keen to seek new challenges and work collaboratively with colleagues and partners across the world to deliver solutions? The work of the Toxicology, Trauma and Medicine Group within the Chemical, Biological and Radiological (CBR) Division is aimed at understanding and mitigating the lethal and incapacitating effects of various chemical and biological insults on the human body. Suitable medical countermeasures (small molecule drugs or biologicals) are identified within the research space, with successful candidate products taken forward into the Advanced Development Programme (ADP) to work towards a MAA. Candidate pharmaceutical products which progress to the Advanced Development Programme are rigorously tested to ensure they meet the quality, safety and efficacy standards required for licensure by the regulatory authorities. The research and development outcomes may inform a range of strategic and policy decisions across MOD and wider government. We are seeking a Pharmaceutical Regulatory Affairs Specialist to join the Advanced Development Programme (ADP) team. You will join a small, busy, multi-disciplinary team comprising of subject matter experts, to deliver safe and efficacious medical countermeasure products licensed by the regulatory authorities. The primary focus for the successful candidate will be a range of regulatory activities across the lifecycle of the Dstl pharmaceutical product portfolio, which includes a diverse range of products in development. Dstl recognises the importance of diversity and inclusion as people from diverse backgrounds bring fresh ideas. We are committed to building an inclusive working environment in which each employee fulfils their potential and maximises their contribution. We particularly welcome female and ethnic minority applicants and those from the LGBTQI community, as they are under-represented within Dstl at these levels. Job description In this role you will: Prepare and drive regulatory development plans for each product to ensure seamless transition between development phases Prepare/contribute to TPPs, IBs and IMPDs Prepare/manage CTAs and related supporting activities Ensure robust regulatory plans are established and followed in order to support future pharmaceutical licensing applications Work collaboratively across interdisciplinary teams to ensure robust studies are planned, carried out to the required regulatory standards and reported appropriately Provide robust and reliable regulatory advice to MOD stakeholders to enable informed decision making Exercise good judgement to reach evidence-based decisions and be confident and clear in presenting your ideas and work to a variety of technical and non-technical audiences Develop regulatory documentation and make timely submissions to regulatory authorities Support the production of marketing authorisation applications (externally delivered) Manage and conduct interactions with external regulatory authorities and ensure positive and trusted relationships are developed. Assist in building electronic document structures to aid future electronic CTD compilation Maintain currency in regulatory affairs regulations and requirements affecting pharmaceutical product development activities at Dstl Promote and raise the importance of regulatory affairs issues within the organisation and amongst stakeholders Maintain and communicate regulatory intelligence. Work effectively in a team Organise your time and be able to prioritise activities across a number of diverse activities Work safely in accordance with Dstl policies and procedures Responsibilities We are looking for an individual who has a significant level of experience applying expert regulatory knowledge to the pharmaceutical development lifecycle to join the ADP team. You will have prior experience in applying regulatory legislation and will have had previous interactions with the regulatory authorities, especially the MHRA. The successful candidate will work across teams, scientists and project managers to enable delivery of the projects. Your responsibilities will include driving the regulatory requirements, decisions and actions, in support of marketing authorisation applications (MAAs) for medical countermeasures. You will be required to engage at all levels within the organisation and externally with the MOD and other organisations, including regulatory authorities. You will have: Extensive experience of applying expert regulatory knowledge to the pharmaceutical development lifecycle Experience in a pharmaceutical company or CRO A good working knowledge of all current regulatory guidelines and regulations Strong understanding of CMC requirements Experience of constructing regulatory plans/strategies for pharmaceutical development projects Experience of contributing to/preparing Target Product Profiles (TPPs), Investigator's Brochures (IBs) and Investigational Medicinal Product Dossiers (IMPDs) Experience of preparing/managing Clinical Trial Applications (CTAs) Experience of interacting with regulatory authorities At least 3 years of regulatory affairs experience in pharmaceutical development A proven track record of working collaboratively within teams The ability to organise, plan and implement projects to deadlines Strong written and verbal communication skills A commitment to undertake continuing professional development throughout their career. Essential Skills and Experience You will have extensive experience of regulatory affairs experience in pharmaceutical development (pharmaceutical company or CRO) You will have a good working knowledge of current regulatory guidelines and regulations You will have a good working knowledge of the pharmaceutical development lifecycle You will have good working knowledge of the clinical trials regulations You will have demonstrable experience of contributing to/preparing TPPs, IBs and IMPDs You will have demonstrable experience of preparing and/or managing CTAs You will have demonstrable experience of interactions with regulatory authorities You will have the ability to work methodically with good attention to detail You will have good IT skills. Leadership As a leader in Defence you will help shape, role model and bring to life the 'One Defence' mindset that will enable us to deliver our vision and strategic objectives. Your leadership style must be inspiring, confident and empowering. Working at every level of our organisation to break down silos, unite teams and create a culture that is trusting, collaborative, innovative, diverse and inclusive. Enabling us to deliver with pace and agility through the skills, commitment and empowerment of our employees and military colleagues. Important Information Our work in defence, security and intelligence requires our employees to be UK Nationals who are able to gain a high level of security clearance to undertake the projects we are involved in to protect us from security threats. For this reason, only UK Nationals will be able to apply for this role. If you are an international or dual-national candidate, and you think you have the skills we need, please consider applying to any of our government, security or defence partners. This role will require full UK security clearance and you should have resided in the UK for the past 5 years. For some roles Developed Vetting will also be required, in this case you should have resided in the UK for the past 10 years. Behaviours We'll assess you against these behaviours during the selection process: Making Effective Decisions Working Together Delivering at Pace Leadership
The Role The role is within a growing and dynamic centralised Insolvency Delivery Team ("IDT") supporting all Teneo offices on all insolvency assignments. The role will be within sub-teams with each team dealing with c.50-70 cases and managing the day to day aspects of all new and existing insolvency cases. The Financial Advisory Team at Teneo Teneo's global Financial Advisory business advises corporates, creditors and other financial stakeholders in situations of financial stress and distress. No two situations are the same. Our advice and approach is tailored to each situation and each client. At Teneo, we believe such occurrences present new opportunities for our clients. Opportunities to restore value, raise new capital, pivot in a new direction and ultimately, identify certainty amidst chaos. Teneo partners with clients to find viable opportunities that will protect and enhance value and help them to build strategies that will most benefit their business and/or investment goals. Integrating the disciplines of Financial Advisory, financial advisory, management consulting, investor relations, strategic communications, government affairs, risk analysis and talent advisory, Teneo's global Financial Advisory team guides companies and their stakeholders through periods of uncertainty and stress. We help address the challenges a business faces, whether that is targeted performance improvement to Financial Advisory, or delivering a route to recover value, our focus is delivering certainty from uncertainty Key Responsibilities As an Insolvency Purchase/Sales Ledger Assistant, the primary nature of work that you will get involved with will likely include: All day to day case supervisor responsibilities including: Supporting case managers with case strategy and delivering case strategy; Managing and completing statutory diary lines, compliance returns, case reviews etc.; Assisting with supervising trading and processing receipts and payments; Drafting letters and statutory documents; Preparing progress reports for creditors including receipts and payment accounts and estimated outcome statements; Drafting reports to secured creditors where relevant; Other exercises will include: Responding to creditors queries and answering correspondence; Preparing and drafting CDDA submissions; Agreeing creditor claims and calculating creditor distributions; and Preparing receipt and expenses vouchers and journals. Supervising the work of case administrators and secondees from other departments. Developing talent through delegating work appropriately and providing support and feedback to case administrators and secondees, to help them progress their careers. Working with our Joint Venture team to complete tasks. Attending site & providing ongoing site support as the local office teams may require. Liaising with internal stakeholders (IPs and senior local office team staff) to provide updates on case progression matters and to assist more senior members of the IDT with planning for the delivery of new work. Ensuring best practice/firm/regulatory requirements are adhered to and that the firm's commitment to quality is reflected in all written output for creditors/other external stakeholders. Key Skills & Experience Corporate insolvency experience gained within the restructuring department of a firm or in a specialist insolvency practice, and in particular experience of managing tasks across a case load and using a case management system (e.g. IPS). A good understanding of key statutory requirements through the lifecycle of different corporate insolvency procedures. 'Qualified by experience' and/or holding relevant professional qualifications such as ATT, CPI etc. Strong risk awareness, with the knowledge/confidence to escalate risk issues appropriately. Excellent communication and interpersonal skills, as you would be dealing with all kinds of internal and external stakeholders. Experience in delegating tasks and reviewing the work of more junior staff. Experienced in using Word, Excel and Power Point. A strong and flexible work ethic. A confident and enthusiastic team player. What can we offer you? New joiners are supported by an induction programme. As well as this we offer a whole host of benefits and reward including; Market-leading Salary 25 days holiday Discretionary Bonus Scheme Company Pension Scheme Extensive investment in personal development & learning Enhanced maternity and paternity leave (depending on length of service) and shared parental leave Private medical insurance Life assurance Group income protection Cycle to work schemes Regular social, cultural and charitable activities About Teneo Teneo advises business leaders, enabling them to achieve goals faster and at lower cost by earning trust, navigating disruption and removing barriers. We are built to help businesses succeed in a world no longer defined by boundaries and disciplines. Working exclusively with the CEOs and senior executives of the world's leading companies, Teneo provides strategic counsel across their full range of key objectives and issues. Our clients include a significant number of the FTSE 100 and Fortune 100, as well as other global public and private corporations. We're an ambitious, global consultancy which allows candidates unmatched opportunities to develop and work with inspiring, motivated people. Our teams bring together the disciplines of strategic communications, investor relations, restructuring, management consulting, physical & cyber risk, financial advisory, corporate governance advisory, ESG, DE&I, political & policy risk, and talent advisory, to solve for the most complex business challenges and opportunities. We aim to make companies and institutions stronger and more valuable. We are capable of advising at the most senior levels across the world's leading businesses and organisations and we're proud to work with some of the strongest brands in the world. Across the globe, Teneo employs more than 1,200 people, offering global reach from a light infrastructure, built out of regional hubs. Our culture is critical to our success. We have a flat management structure with an open and supportive office atmosphere. To support progression and learning, we foster a supportive environment with a focus on mental health and wellbeing as well as adopting an inclusive environment that allows all employees to flourish. We recognise that diversity is essential for our business and encourage applicants from all backgrounds. At Teneo, we have fully embraced hybrid working and redefined the way we work such that it facilitates collaboration, optimises productivity and promotes the health and wellbeing of our people. We are also happy to discuss other forms of flexible working so please let us know if this is something you would like to discuss.
Sep 23, 2022
Full time
The Role The role is within a growing and dynamic centralised Insolvency Delivery Team ("IDT") supporting all Teneo offices on all insolvency assignments. The role will be within sub-teams with each team dealing with c.50-70 cases and managing the day to day aspects of all new and existing insolvency cases. The Financial Advisory Team at Teneo Teneo's global Financial Advisory business advises corporates, creditors and other financial stakeholders in situations of financial stress and distress. No two situations are the same. Our advice and approach is tailored to each situation and each client. At Teneo, we believe such occurrences present new opportunities for our clients. Opportunities to restore value, raise new capital, pivot in a new direction and ultimately, identify certainty amidst chaos. Teneo partners with clients to find viable opportunities that will protect and enhance value and help them to build strategies that will most benefit their business and/or investment goals. Integrating the disciplines of Financial Advisory, financial advisory, management consulting, investor relations, strategic communications, government affairs, risk analysis and talent advisory, Teneo's global Financial Advisory team guides companies and their stakeholders through periods of uncertainty and stress. We help address the challenges a business faces, whether that is targeted performance improvement to Financial Advisory, or delivering a route to recover value, our focus is delivering certainty from uncertainty Key Responsibilities As an Insolvency Purchase/Sales Ledger Assistant, the primary nature of work that you will get involved with will likely include: All day to day case supervisor responsibilities including: Supporting case managers with case strategy and delivering case strategy; Managing and completing statutory diary lines, compliance returns, case reviews etc.; Assisting with supervising trading and processing receipts and payments; Drafting letters and statutory documents; Preparing progress reports for creditors including receipts and payment accounts and estimated outcome statements; Drafting reports to secured creditors where relevant; Other exercises will include: Responding to creditors queries and answering correspondence; Preparing and drafting CDDA submissions; Agreeing creditor claims and calculating creditor distributions; and Preparing receipt and expenses vouchers and journals. Supervising the work of case administrators and secondees from other departments. Developing talent through delegating work appropriately and providing support and feedback to case administrators and secondees, to help them progress their careers. Working with our Joint Venture team to complete tasks. Attending site & providing ongoing site support as the local office teams may require. Liaising with internal stakeholders (IPs and senior local office team staff) to provide updates on case progression matters and to assist more senior members of the IDT with planning for the delivery of new work. Ensuring best practice/firm/regulatory requirements are adhered to and that the firm's commitment to quality is reflected in all written output for creditors/other external stakeholders. Key Skills & Experience Corporate insolvency experience gained within the restructuring department of a firm or in a specialist insolvency practice, and in particular experience of managing tasks across a case load and using a case management system (e.g. IPS). A good understanding of key statutory requirements through the lifecycle of different corporate insolvency procedures. 'Qualified by experience' and/or holding relevant professional qualifications such as ATT, CPI etc. Strong risk awareness, with the knowledge/confidence to escalate risk issues appropriately. Excellent communication and interpersonal skills, as you would be dealing with all kinds of internal and external stakeholders. Experience in delegating tasks and reviewing the work of more junior staff. Experienced in using Word, Excel and Power Point. A strong and flexible work ethic. A confident and enthusiastic team player. What can we offer you? New joiners are supported by an induction programme. As well as this we offer a whole host of benefits and reward including; Market-leading Salary 25 days holiday Discretionary Bonus Scheme Company Pension Scheme Extensive investment in personal development & learning Enhanced maternity and paternity leave (depending on length of service) and shared parental leave Private medical insurance Life assurance Group income protection Cycle to work schemes Regular social, cultural and charitable activities About Teneo Teneo advises business leaders, enabling them to achieve goals faster and at lower cost by earning trust, navigating disruption and removing barriers. We are built to help businesses succeed in a world no longer defined by boundaries and disciplines. Working exclusively with the CEOs and senior executives of the world's leading companies, Teneo provides strategic counsel across their full range of key objectives and issues. Our clients include a significant number of the FTSE 100 and Fortune 100, as well as other global public and private corporations. We're an ambitious, global consultancy which allows candidates unmatched opportunities to develop and work with inspiring, motivated people. Our teams bring together the disciplines of strategic communications, investor relations, restructuring, management consulting, physical & cyber risk, financial advisory, corporate governance advisory, ESG, DE&I, political & policy risk, and talent advisory, to solve for the most complex business challenges and opportunities. We aim to make companies and institutions stronger and more valuable. We are capable of advising at the most senior levels across the world's leading businesses and organisations and we're proud to work with some of the strongest brands in the world. Across the globe, Teneo employs more than 1,200 people, offering global reach from a light infrastructure, built out of regional hubs. Our culture is critical to our success. We have a flat management structure with an open and supportive office atmosphere. To support progression and learning, we foster a supportive environment with a focus on mental health and wellbeing as well as adopting an inclusive environment that allows all employees to flourish. We recognise that diversity is essential for our business and encourage applicants from all backgrounds. At Teneo, we have fully embraced hybrid working and redefined the way we work such that it facilitates collaboration, optimises productivity and promotes the health and wellbeing of our people. We are also happy to discuss other forms of flexible working so please let us know if this is something you would like to discuss.
Proclinical are recruiting a Senior Regulatory Executive for a biotech corporation. This role is on a contract basis and is located in Surrey. The client is focused on improving people's everyday health. Responsibilities: Handle country labelling variations and assist the CLS process rendering to approved standards. Evolve replies to regulatory authorities with regional regulatory affairs assistance and crucial shareholders. You will update the GDS aligned with the formed processes and systems. Offer labelling knowledge for RA actions such as renewal, PBRERs. Guarantee compliance of their activities by adhering to forms procedures, policies, SOPs and working instructions. Produce and review the assisted documentation needed for GDS sanction at CHSLC. The deal candidate might serve as a representative to external groups on specific task forces with labelling knowledge, such as digital e-leaflet, etc. Other duties may be assigned to this role. If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
Sep 22, 2022
Full time
Proclinical are recruiting a Senior Regulatory Executive for a biotech corporation. This role is on a contract basis and is located in Surrey. The client is focused on improving people's everyday health. Responsibilities: Handle country labelling variations and assist the CLS process rendering to approved standards. Evolve replies to regulatory authorities with regional regulatory affairs assistance and crucial shareholders. You will update the GDS aligned with the formed processes and systems. Offer labelling knowledge for RA actions such as renewal, PBRERs. Guarantee compliance of their activities by adhering to forms procedures, policies, SOPs and working instructions. Produce and review the assisted documentation needed for GDS sanction at CHSLC. The deal candidate might serve as a representative to external groups on specific task forces with labelling knowledge, such as digital e-leaflet, etc. Other duties may be assigned to this role. If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
Compass Life Science have partnered with one of the world's leading CROs in their search to appoint a Senior Regulatory Affairs Consultant focused on CMC (Biologics). You will be part of a broad Regulatory Affairs group, across the EMEA region. Our client is a specialist in Oncology, CNS and Rare diseases and is rapidly expanding, due to a hugely successful track record delivering excellence for their customers. This is a key hire for the organisation and as such the right candidate must be an experienced Regulatory Affairs Consultant with experience in CMC within a Biotech/Pharma environment. You will need to have the ability to interact as part of a dynamic group that operates the region, so experience of cross region communication with peers, management of clients and project teams and a hands-on approach to leading from the front is key. This is a great opportunity for an experienced Regulatory Affairs Consultant who is looking to progress, take on new projects and see-through development of new breakthroughs in clinical research. Knowledge and Experience The position will be focused on CMC and will need a Good understanding of CMC lifecycle maintenance activities across EU and ROW markets Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data Prepare and coordinate the review and approval of submission-ready documents Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations Strict adherence to timelines (both internal and HA deadlines) Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory submissions throughout the product life cycle (IND, IMPD, NDA, MAA) Location Office based or fully homebased. Travel Only ad-hoc and not as much as the moment due to pandemic Contact Details Offering a very competitive base salary and benefits package, if you are interested in learning more please contact me directly today as we are looking to appoint as soon as possible. For further information please contact me , or phone (0). If you would like a call back please email or text (0) Referrals Compass Associates Ltd trading as Compass Life Sciences are acting as a Recruitment Consultancy for this Permanent Vacancy; We offer up to £1,000 worth of Amazon vouchers for each successful recommendation.
Sep 22, 2022
Full time
Compass Life Science have partnered with one of the world's leading CROs in their search to appoint a Senior Regulatory Affairs Consultant focused on CMC (Biologics). You will be part of a broad Regulatory Affairs group, across the EMEA region. Our client is a specialist in Oncology, CNS and Rare diseases and is rapidly expanding, due to a hugely successful track record delivering excellence for their customers. This is a key hire for the organisation and as such the right candidate must be an experienced Regulatory Affairs Consultant with experience in CMC within a Biotech/Pharma environment. You will need to have the ability to interact as part of a dynamic group that operates the region, so experience of cross region communication with peers, management of clients and project teams and a hands-on approach to leading from the front is key. This is a great opportunity for an experienced Regulatory Affairs Consultant who is looking to progress, take on new projects and see-through development of new breakthroughs in clinical research. Knowledge and Experience The position will be focused on CMC and will need a Good understanding of CMC lifecycle maintenance activities across EU and ROW markets Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data Prepare and coordinate the review and approval of submission-ready documents Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations Strict adherence to timelines (both internal and HA deadlines) Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory submissions throughout the product life cycle (IND, IMPD, NDA, MAA) Location Office based or fully homebased. Travel Only ad-hoc and not as much as the moment due to pandemic Contact Details Offering a very competitive base salary and benefits package, if you are interested in learning more please contact me directly today as we are looking to appoint as soon as possible. For further information please contact me , or phone (0). If you would like a call back please email or text (0) Referrals Compass Associates Ltd trading as Compass Life Sciences are acting as a Recruitment Consultancy for this Permanent Vacancy; We offer up to £1,000 worth of Amazon vouchers for each successful recommendation.
* SUMMARY: This is a seasoned leadership role accountable for site activation project management and delivery in the Site Activation and Regulatory (SAR) department. Project activities include site identification, investigator and site contracts, central and local EC submissions, Competent Authority submissions and any other country and/or study specific activities necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). It may also include proposal and budget management or feasibility/site identification activities. Reports to the Site Activation and Regulatory Therapeutic Lead or may report to a Site Activation Portfolio Manager if assigned to a portfolio or program of studies * *RESPONSIBILITIES:* * Serve as the primary point of communication and accountability for start-up and maintenance (if applicable) activities on assigned projects * Lead and manage assigned SAR project teams to achieve successful delivery of milestone achievements and any key performance indicators * May perform line management activities with; responsibility for direct report performance, development and administrative compliance * Oversee project activities of Regulatory Affairs Specialists and Site Activation Specialists to ensure critical path activities completed on time * Ensure accurate compilation, management, tracking and analysis of site activation activities in timely manner * Work closely with assigned team members to expedite the Site Qualification and Selection process * Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team * Lead risk assessment and mitigation plans relating to departmental deliverables with input from other roles * Work with and lead project team members to develop site activation related project plans, such as the study-specific Site Activation Plan which includes all activities required to activate sites for a specific study ensuring each task has a clear owner and due date. Liaise with other functional contributors and vendors as needed. * Help develop, review, and maintain SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation department * Lead/provide input to departmental process improvement initiatives * Recommend, establish and interpret site activation metrics; drive corrective action to achieve deliverables, milestones and KPIs * May participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals budgets, and other country and/or study specific activities related to Site Activation * Report and/or escalate issues to Site Activation & Regulatory Therapeutic Lead as necessary to ensure resolution and minimize risks to on-time deliverables * Comply with SOPs, ICH GCP and national regulations as applicable * May lead or support feasibility or site identification activities * Liaise with other functional contributors and vendors as needed * OTHER SKILLS AND ABILITIES: * * Proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing * Demonstrated ability to exercise sound judgment and consistently make decisions independently to proactively prevent and solve problems * Demonstrated ability to consistently positively impact initiatives relating to interacting with sites and/or customers * Demonstrated ability to motivate, lead and engage a team to consistently and successfully achieve meaningful goals * Demonstrated ability to perform and thrive in ambiguous situations * Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment * Strong oral and written communication skills to clearly and concisely present information * Demonstrated ability to collaborate across the business * Team-oriented work style; seeks and gives guidance * Thorough understanding of regulatory processes, guidelines, and the application of local regulatory requirements * Thorough understanding of initiation, planning, and execution of clinical projects and overall project planning * Thorough awareness of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications) * Demonstrated ability to handle multiple tasks in a fast-paced and constantly changing environment * Demonstrated ability to work in an organized, methodical and self-motivated manner * Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude * REQUIREMENTS: * * A minimum four-year college curriculum or equivalent with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR... * Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and four years' experience within clinical research (e.g. CRA, Reg Affairs.) * Plus a minimum of 7 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience * Proficient in cross-cultural communication * Proficient in both spoken and written English #LI-MP1 #LI-Remote
Feb 25, 2022
Full time
* SUMMARY: This is a seasoned leadership role accountable for site activation project management and delivery in the Site Activation and Regulatory (SAR) department. Project activities include site identification, investigator and site contracts, central and local EC submissions, Competent Authority submissions and any other country and/or study specific activities necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). It may also include proposal and budget management or feasibility/site identification activities. Reports to the Site Activation and Regulatory Therapeutic Lead or may report to a Site Activation Portfolio Manager if assigned to a portfolio or program of studies * *RESPONSIBILITIES:* * Serve as the primary point of communication and accountability for start-up and maintenance (if applicable) activities on assigned projects * Lead and manage assigned SAR project teams to achieve successful delivery of milestone achievements and any key performance indicators * May perform line management activities with; responsibility for direct report performance, development and administrative compliance * Oversee project activities of Regulatory Affairs Specialists and Site Activation Specialists to ensure critical path activities completed on time * Ensure accurate compilation, management, tracking and analysis of site activation activities in timely manner * Work closely with assigned team members to expedite the Site Qualification and Selection process * Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team * Lead risk assessment and mitigation plans relating to departmental deliverables with input from other roles * Work with and lead project team members to develop site activation related project plans, such as the study-specific Site Activation Plan which includes all activities required to activate sites for a specific study ensuring each task has a clear owner and due date. Liaise with other functional contributors and vendors as needed. * Help develop, review, and maintain SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation department * Lead/provide input to departmental process improvement initiatives * Recommend, establish and interpret site activation metrics; drive corrective action to achieve deliverables, milestones and KPIs * May participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals budgets, and other country and/or study specific activities related to Site Activation * Report and/or escalate issues to Site Activation & Regulatory Therapeutic Lead as necessary to ensure resolution and minimize risks to on-time deliverables * Comply with SOPs, ICH GCP and national regulations as applicable * May lead or support feasibility or site identification activities * Liaise with other functional contributors and vendors as needed * OTHER SKILLS AND ABILITIES: * * Proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing * Demonstrated ability to exercise sound judgment and consistently make decisions independently to proactively prevent and solve problems * Demonstrated ability to consistently positively impact initiatives relating to interacting with sites and/or customers * Demonstrated ability to motivate, lead and engage a team to consistently and successfully achieve meaningful goals * Demonstrated ability to perform and thrive in ambiguous situations * Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment * Strong oral and written communication skills to clearly and concisely present information * Demonstrated ability to collaborate across the business * Team-oriented work style; seeks and gives guidance * Thorough understanding of regulatory processes, guidelines, and the application of local regulatory requirements * Thorough understanding of initiation, planning, and execution of clinical projects and overall project planning * Thorough awareness of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications) * Demonstrated ability to handle multiple tasks in a fast-paced and constantly changing environment * Demonstrated ability to work in an organized, methodical and self-motivated manner * Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude * REQUIREMENTS: * * A minimum four-year college curriculum or equivalent with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR... * Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and four years' experience within clinical research (e.g. CRA, Reg Affairs.) * Plus a minimum of 7 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience * Proficient in cross-cultural communication * Proficient in both spoken and written English #LI-MP1 #LI-Remote
Newton Colmore Consulting Ltd
Cambridge, Cambridgeshire
Post-Doc Chemist - Battery Technology - Cambridge A rapidly growing scientific technology house based in Cambridge are in the process of expansion and are actively looking to strengthen their in-house research team by bringing on a Post-Doc Chemist to work on battery technologies. As a Post-Doc Chemist, you will be charged with developing the company's next generation energy storage materials. This will include working within a multidisciplinary team or scientist and engineers to maximise the performance of battery materials and contribute to developing a deep understanding of the key structure - property relationships in functional battery materials and materials formulations. Some other key parts to the role will include; Formulation of functional material inks and pastes and their pre-device fabrication physical characterisation. Creative contributions to brainstorms, studies, and project meeting discussions. Proposal and design of novel materials and recommendations to solve chemical synthetic issues. To be considered for this role we are looking for people with strong knowledge of synthetic organic chemistry and polymers that complements a PhD in Chemistry. Any experience with battery technologies or electrochemical techniques would be a significant advantage. In return for your hard work the company offer a highly competitive salary and benefits package as well providing excellent career progression opportunities and the chance to work on leading edge technologies. This is a 2 year fixed term contract with possibilities for future roles in within the organisation. For more information contact Matthew Lowdon of Newton Colmore Consulting on . To enter the recruitment process click apply now and if you have the right skills and expertise I will be in touch to discuss the opportunity further. Newton Colmore Consulting is a highly specialist recruitment consultancy operating within the medical devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors throughout Europe and the US. Keywords: Senior Chemist, Energy Storage Systems, Synthetic Chemistry, OLED, Materials Engineering, organometallic.
Feb 22, 2022
Full time
Post-Doc Chemist - Battery Technology - Cambridge A rapidly growing scientific technology house based in Cambridge are in the process of expansion and are actively looking to strengthen their in-house research team by bringing on a Post-Doc Chemist to work on battery technologies. As a Post-Doc Chemist, you will be charged with developing the company's next generation energy storage materials. This will include working within a multidisciplinary team or scientist and engineers to maximise the performance of battery materials and contribute to developing a deep understanding of the key structure - property relationships in functional battery materials and materials formulations. Some other key parts to the role will include; Formulation of functional material inks and pastes and their pre-device fabrication physical characterisation. Creative contributions to brainstorms, studies, and project meeting discussions. Proposal and design of novel materials and recommendations to solve chemical synthetic issues. To be considered for this role we are looking for people with strong knowledge of synthetic organic chemistry and polymers that complements a PhD in Chemistry. Any experience with battery technologies or electrochemical techniques would be a significant advantage. In return for your hard work the company offer a highly competitive salary and benefits package as well providing excellent career progression opportunities and the chance to work on leading edge technologies. This is a 2 year fixed term contract with possibilities for future roles in within the organisation. For more information contact Matthew Lowdon of Newton Colmore Consulting on . To enter the recruitment process click apply now and if you have the right skills and expertise I will be in touch to discuss the opportunity further. Newton Colmore Consulting is a highly specialist recruitment consultancy operating within the medical devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors throughout Europe and the US. Keywords: Senior Chemist, Energy Storage Systems, Synthetic Chemistry, OLED, Materials Engineering, organometallic.
Regulatory Affairs Senior Associate / Project Manager - Change Lead. Are you already a Senior Regulatory Associate focusing on Life-cycle management? If so, this is the opportunity you have been waiting for. This Regulatory Affairs Change Lead, Life-cycle Change Management, is for a fast-growing Specialist Pharma Company in the Middlesex/Northwest London area; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas. Reporting to the Regulatory Affairs Change Team Leader, you will Project Lead and Manage in Post approval activity. You will be responsible for the Life-cycle Changes. You will ensure prioritisation, planning and execution of Post Marketing activity across the Product Portfolio. You will liaise with Regulatory Managers and Service providers to ensure effective implementation and effect plans to harmonise how Regulatory Projects are managed and improved. Technically, you will have good working knowledge and experience of Registrations and Post marketing activity/Life-cycle management; CTD/Dossiers for MAA's (ideally, all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Your geographic scope will be Pan-European and some International territories. An excellent salary package awaits the successful candidate. Northwest London Location but hybrid working arrangements. Candidates from a Pharma or Biologics background in European & International Regulatory Life-cycle management with approximately 5 years' experience, and good mentoring skills should be suitable for this position. You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail. If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on / or by clicking Apply Now.
Feb 22, 2022
Full time
Regulatory Affairs Senior Associate / Project Manager - Change Lead. Are you already a Senior Regulatory Associate focusing on Life-cycle management? If so, this is the opportunity you have been waiting for. This Regulatory Affairs Change Lead, Life-cycle Change Management, is for a fast-growing Specialist Pharma Company in the Middlesex/Northwest London area; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas. Reporting to the Regulatory Affairs Change Team Leader, you will Project Lead and Manage in Post approval activity. You will be responsible for the Life-cycle Changes. You will ensure prioritisation, planning and execution of Post Marketing activity across the Product Portfolio. You will liaise with Regulatory Managers and Service providers to ensure effective implementation and effect plans to harmonise how Regulatory Projects are managed and improved. Technically, you will have good working knowledge and experience of Registrations and Post marketing activity/Life-cycle management; CTD/Dossiers for MAA's (ideally, all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Your geographic scope will be Pan-European and some International territories. An excellent salary package awaits the successful candidate. Northwest London Location but hybrid working arrangements. Candidates from a Pharma or Biologics background in European & International Regulatory Life-cycle management with approximately 5 years' experience, and good mentoring skills should be suitable for this position. You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail. If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on / or by clicking Apply Now.
Newton Colmore Consulting Ltd
Cambridge, Cambridgeshire
Surface Chemistry Scientist - Electrochemistry - Cambridge I am working with an exciting biotechnology instrument developer in Cambridge who are looking for an electrochemistry scientist to join their lab-based team of scientists. This exciting new role will give you an excellent opportunity to work on cutting edge products at the forefront of the sector. As this is a relatively tight-knit team, you will need to take a hands-on approach and will be utilising your surface chemistry expertise to develop novel solutions to complex scientific problems alongside physicists, engineers, and scientists. This will include using your knowledge of electrodes characterisation and electrochemical techniques. You will play a key role in developing and scaling up the company's key components which integrate into a product that sits at the intersection of science and engineering. Because of the nature of this company, you will always have new projects/products on the horizon meaning you will never get bored. To be considered for this exciting role you will need to have the following; Experience with the characterisation of electrodes coupled with knowledge of electrochemistry. Ideally educated to PhD level in chemistry Familiarity with microfluidics and microarray printing. In exchange for your skills and expertise, the company offer a highly competitive package tailored to you which includes a salary to match your expectations as well as share options. For more information, please call Matthew Lowdon of Newton Colmore Consulting on or make an application and one of our team will be in touch. Newton Colmore Consulting is a highly specialist recruitment consultancy operating within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors throughout Europe and the US. Key words: Biotechnology, Chemistry, Electrode Design, Electrochemistry, Cambridge
Jan 10, 2022
Full time
Surface Chemistry Scientist - Electrochemistry - Cambridge I am working with an exciting biotechnology instrument developer in Cambridge who are looking for an electrochemistry scientist to join their lab-based team of scientists. This exciting new role will give you an excellent opportunity to work on cutting edge products at the forefront of the sector. As this is a relatively tight-knit team, you will need to take a hands-on approach and will be utilising your surface chemistry expertise to develop novel solutions to complex scientific problems alongside physicists, engineers, and scientists. This will include using your knowledge of electrodes characterisation and electrochemical techniques. You will play a key role in developing and scaling up the company's key components which integrate into a product that sits at the intersection of science and engineering. Because of the nature of this company, you will always have new projects/products on the horizon meaning you will never get bored. To be considered for this exciting role you will need to have the following; Experience with the characterisation of electrodes coupled with knowledge of electrochemistry. Ideally educated to PhD level in chemistry Familiarity with microfluidics and microarray printing. In exchange for your skills and expertise, the company offer a highly competitive package tailored to you which includes a salary to match your expectations as well as share options. For more information, please call Matthew Lowdon of Newton Colmore Consulting on or make an application and one of our team will be in touch. Newton Colmore Consulting is a highly specialist recruitment consultancy operating within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors throughout Europe and the US. Key words: Biotechnology, Chemistry, Electrode Design, Electrochemistry, Cambridge