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    7 Contract Pharmaceutical jobs found in South East

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      • high wycombe, south east
      • contract
      • randstad cpe
      Are you an experienced Regulatory Clinical Trial Application Submission manager? We are recruiting for a CTA Submission Manager to work for a leading Pharma client at their site based in High-Wycombe on a contract basis for 6 months initially. The successful candidate will be managing regulatory Clinical Trial Applications submission activities for assigned clinical trials Phase 1 - Phase 4 spanning across six therapeutic areas including Oncology, Neuroscience, Cardiovascular and Metabolism, Pulmonary Hypertension, Immunology, and Infectious Diseases. You will have experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.Responsibilities:Ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.The CTA submission manager ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking systemIf CRO's are contracted to handle aspects as outlined above, the submission manager will be responsible for liaising with and overseeing CRO staffIdentifies and proactively responds to issues, problems, or opportunities as it relates to the leading the CTA workgroupIndependently identifies the need for and collects information to better understand and resolve issues/challenges and seize opportunitiesIntegrates information from a variety of sources, detects trends, associations, and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriateMakes decisions independently for day-to-day activities of CTA workgroupDecisions as they relate to changing processes that affect external stakeholders require consultation with supervisor and CTA Process OwnerExperience: Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is requiredKnowledgeable with scientific terminologyIdeal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industryAn understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also requiredMust have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occurMust have strong project management skills Ability to lead complex projects and a high degree of problem solving capability requiredMust have a high level of Self-Awareness and Adaptability and strong impact and influencing skillsMust have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organizationMust be able to work independently, strong initiative Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
      Are you an experienced Regulatory Clinical Trial Application Submission manager? We are recruiting for a CTA Submission Manager to work for a leading Pharma client at their site based in High-Wycombe on a contract basis for 6 months initially. The successful candidate will be managing regulatory Clinical Trial Applications submission activities for assigned clinical trials Phase 1 - Phase 4 spanning across six therapeutic areas including Oncology, Neuroscience, Cardiovascular and Metabolism, Pulmonary Hypertension, Immunology, and Infectious Diseases. You will have experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.Responsibilities:Ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.The CTA submission manager ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking systemIf CRO's are contracted to handle aspects as outlined above, the submission manager will be responsible for liaising with and overseeing CRO staffIdentifies and proactively responds to issues, problems, or opportunities as it relates to the leading the CTA workgroupIndependently identifies the need for and collects information to better understand and resolve issues/challenges and seize opportunitiesIntegrates information from a variety of sources, detects trends, associations, and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriateMakes decisions independently for day-to-day activities of CTA workgroupDecisions as they relate to changing processes that affect external stakeholders require consultation with supervisor and CTA Process OwnerExperience: Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is requiredKnowledgeable with scientific terminologyIdeal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industryAn understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also requiredMust have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occurMust have strong project management skills Ability to lead complex projects and a high degree of problem solving capability requiredMust have a high level of Self-Awareness and Adaptability and strong impact and influencing skillsMust have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organizationMust be able to work independently, strong initiative Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
      • oxford, south east
      • contract
      • £27,000 - £28,000 per year
      • randstad business support
      Job Title: Data Management Analyst Location: Witney - Hybrid (2 days at home)Pay rate: £28,000 p,aContract: 12 Months (potential for permanent) Able to quickly learn and retain knowledge about new domains, technologies and approaches? Are you tech savvy and competent in excel? Is your work thorough and organised?Our client is a global healthcare organisation, who's main site in Witney is a hub of innovation and creativity. They are looking for a detail oriented person, with a positive attitude, to join the team as a Data Management Analyst. Key Responsibilities:Perform upload and verification of data from multiple sources.Track the entry and migration of clinical data and work with study team to identify erroneous, missing or incomplete data.Generate and track data queries to address data issues identified during verification.Document and verify transfer of clinical data.Perform qualification testing for in-house software.Perform data back-up when study laptops are returned.Report generation and preparing supporting documentationRequirements:A recent graduate or someone with a couple of years experience will be consideredMust be familiar with Microsoft packages - good knowledge of Excel. An analytical mindExperience working with multiple data sets would be an advantagePositive attitude and a willingness to learn Please apply with an up to date CV today and someone from the team will be in touch!Randstad Business Support is acting as an Employment Business in relation to this vacancy.
      Job Title: Data Management Analyst Location: Witney - Hybrid (2 days at home)Pay rate: £28,000 p,aContract: 12 Months (potential for permanent) Able to quickly learn and retain knowledge about new domains, technologies and approaches? Are you tech savvy and competent in excel? Is your work thorough and organised?Our client is a global healthcare organisation, who's main site in Witney is a hub of innovation and creativity. They are looking for a detail oriented person, with a positive attitude, to join the team as a Data Management Analyst. Key Responsibilities:Perform upload and verification of data from multiple sources.Track the entry and migration of clinical data and work with study team to identify erroneous, missing or incomplete data.Generate and track data queries to address data issues identified during verification.Document and verify transfer of clinical data.Perform qualification testing for in-house software.Perform data back-up when study laptops are returned.Report generation and preparing supporting documentationRequirements:A recent graduate or someone with a couple of years experience will be consideredMust be familiar with Microsoft packages - good knowledge of Excel. An analytical mindExperience working with multiple data sets would be an advantagePositive attitude and a willingness to learn Please apply with an up to date CV today and someone from the team will be in touch!Randstad Business Support is acting as an Employment Business in relation to this vacancy.
      • high wycombe, south east
      • contract
      • randstad cpe
      Are you an experienced Translational Science Lead? We are recruiting for a consumer healthcare client at their site based in High-Wycombe on a contract basis for 6 months initially. The successful candidate will be supporting the shaping of future clinical protocols. This is a part time role, working 25 hours a week, outside IR35. Responsibilities:Work with R&D team and franchise team to shape short and long term KOL advocacy strategy in EMEARepresentation at key congresses and roundtables with KOLsPublication strategyWork with R&D team to influence shaping of future clinical protocolsDevelopment of key scientific claimsCapability plan to activate in key marketsExperience: Masters Degree or EquivalentTeamwork experienceProject management skillsOral & written communication skillsOrganisational & multi-tasking skillsKnowledge of guidelines and practice of EMEA regions Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
      Are you an experienced Translational Science Lead? We are recruiting for a consumer healthcare client at their site based in High-Wycombe on a contract basis for 6 months initially. The successful candidate will be supporting the shaping of future clinical protocols. This is a part time role, working 25 hours a week, outside IR35. Responsibilities:Work with R&D team and franchise team to shape short and long term KOL advocacy strategy in EMEARepresentation at key congresses and roundtables with KOLsPublication strategyWork with R&D team to influence shaping of future clinical protocolsDevelopment of key scientific claimsCapability plan to activate in key marketsExperience: Masters Degree or EquivalentTeamwork experienceProject management skillsOral & written communication skillsOrganisational & multi-tasking skillsKnowledge of guidelines and practice of EMEA regions Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
      • high wycombe, south east
      • contract
      • randstad cpe
      Are you an experienced Regulatory Affairs Professional? We are recruiting for an EMEA Regulatory Professional to work for a Pharmaceutical client at their site based in High-Wycombe on a contract basis for 12 months initially. The successful candidate will be able to support the regional regulatory strategy for products in their oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations. Responsibilities:Input in development, post-approval and Life cycle managementAdvise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assignedHave an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic areaLiaison with Regulatory Agencies and Local Operating CompaniesDraft cover letters for Regulatory Agency communicationAssist in the preparation of meetings with Regulatory AgenciesLiaise with LOCs, track and respond to queries in a timely mannerAssist in development of processes related to regulatory submissionsDraft and review some document content (depending on level of regulatory knowledge / expertise)Provide input to documentation to ensure they thoroughly and accurately answer the questions being posedTrack dates of submissions and Regulatory Agency responsesClinical Trial Applications (CTA)Review protocols and ensure alignment with regulatory requirementsAdvise team on required documents and submission strategies in preparation of CTAsEnsure CTA submission packages are complete and available according to agreed timelinesReview and approve clinical trial supply plansMarketing Authorization Applications (MAA)Provide regulatory support throughout registration processProvide regulatory support throughout life-cycle managementAdvise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activitiesAssist with submission and acceptance of MAAEnsure country-specific submission packages are made available to the LOCs in accordance with agreed plansExperience: University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experienceExperience in regulatory affairsTeamwork experienceProject management skillsOral & written communication skillsOrganization & multi-tasking skillsKnowledge of the regulatory environment, guidelines and practice of EMEA regions Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
      Are you an experienced Regulatory Affairs Professional? We are recruiting for an EMEA Regulatory Professional to work for a Pharmaceutical client at their site based in High-Wycombe on a contract basis for 12 months initially. The successful candidate will be able to support the regional regulatory strategy for products in their oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations. Responsibilities:Input in development, post-approval and Life cycle managementAdvise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assignedHave an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic areaLiaison with Regulatory Agencies and Local Operating CompaniesDraft cover letters for Regulatory Agency communicationAssist in the preparation of meetings with Regulatory AgenciesLiaise with LOCs, track and respond to queries in a timely mannerAssist in development of processes related to regulatory submissionsDraft and review some document content (depending on level of regulatory knowledge / expertise)Provide input to documentation to ensure they thoroughly and accurately answer the questions being posedTrack dates of submissions and Regulatory Agency responsesClinical Trial Applications (CTA)Review protocols and ensure alignment with regulatory requirementsAdvise team on required documents and submission strategies in preparation of CTAsEnsure CTA submission packages are complete and available according to agreed timelinesReview and approve clinical trial supply plansMarketing Authorization Applications (MAA)Provide regulatory support throughout registration processProvide regulatory support throughout life-cycle managementAdvise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activitiesAssist with submission and acceptance of MAAEnsure country-specific submission packages are made available to the LOCs in accordance with agreed plansExperience: University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experienceExperience in regulatory affairsTeamwork experienceProject management skillsOral & written communication skillsOrganization & multi-tasking skillsKnowledge of the regulatory environment, guidelines and practice of EMEA regions Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
      • witney, south east
      • contract
      • £25,000 - £35,000 per year
      • randstad business support
      JOB TITLE: StatisticianCONTRACT LENGTH: 12 Months (Potential Perm)PAY RATE: £25K to £35K Per Annum (DOE)LOCATION: Witney - Office based Purpose of this role To support clinical study activities and the development of products and testing procedures through the application of statistical methods to products and processes. Your new responsibilities Demonstrate the ability to apply knowledge of statistical concepts into practice.Provide statistical support in the development of new products through to launch under direction of senior colleagues.Support the statistical development, evaluation and verification of stability, calibration and product release methods by useof appropriate statistical methodologies.Analyse results from clinical studies aimed at demonstrating product efficacy and safety.Maintain appropriate records of activities and tasks carried out in compliance with the appropriate Quality Systems.Provide technical support to clinical studies, product development and/or Operations activities to ensure continued smooth running and interaction between departments.Must take responsibility for their individual tasks and understand the impact of their actions on the overall business and other functions.Ideal background and education The minimum education is a BSc in Mathematics or Statistics (or equivalent) to ensure that the jobholder has sufficient technical knowledge to understand and use statistics. Must be accurate and organised in work approach and have good attention to detail in order to ensure that data and analyses are accurate and meet the requirements of the project. Must have good written communication skills to be able to prepare appropriate reports. Must have good oral communication skills to be able to provide management with feedback on development needs and report and present progress. Must have a basic technical and theoretical understanding of projects to be able to extrapolate initial results to predict outcomes and take appropriate actions. Experience in SAS is preferred, must have experience in using word processor applications and spreadsheets to perform suitable data analysis and report writing.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
      JOB TITLE: StatisticianCONTRACT LENGTH: 12 Months (Potential Perm)PAY RATE: £25K to £35K Per Annum (DOE)LOCATION: Witney - Office based Purpose of this role To support clinical study activities and the development of products and testing procedures through the application of statistical methods to products and processes. Your new responsibilities Demonstrate the ability to apply knowledge of statistical concepts into practice.Provide statistical support in the development of new products through to launch under direction of senior colleagues.Support the statistical development, evaluation and verification of stability, calibration and product release methods by useof appropriate statistical methodologies.Analyse results from clinical studies aimed at demonstrating product efficacy and safety.Maintain appropriate records of activities and tasks carried out in compliance with the appropriate Quality Systems.Provide technical support to clinical studies, product development and/or Operations activities to ensure continued smooth running and interaction between departments.Must take responsibility for their individual tasks and understand the impact of their actions on the overall business and other functions.Ideal background and education The minimum education is a BSc in Mathematics or Statistics (or equivalent) to ensure that the jobholder has sufficient technical knowledge to understand and use statistics. Must be accurate and organised in work approach and have good attention to detail in order to ensure that data and analyses are accurate and meet the requirements of the project. Must have good written communication skills to be able to prepare appropriate reports. Must have good oral communication skills to be able to provide management with feedback on development needs and report and present progress. Must have a basic technical and theoretical understanding of projects to be able to extrapolate initial results to predict outcomes and take appropriate actions. Experience in SAS is preferred, must have experience in using word processor applications and spreadsheets to perform suitable data analysis and report writing.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
      • witney, south east
      • contract
      • £75,000 - £80,000 per year
      • abbott
      JOB TITLE: Procurement ManagerSTART DATE: ASAPContract: 12 Months - Perm PotentialPAY RATE: £75,000+ Per Annum LOCATION: Witney, Oxfordshire - Hybrid The Client Specialising in the emerging market of medical devices and diagnostics agents. Our client has a large product area in Diabetes, Arthritis, Spesis, Pregnancy and many more. They are a global client that makes and sells technologically advanced devices that are used within hospitals, homes and other private groups. The Project Due to continued business growth and internal progression, we have an exciting opportunity for a Procurement Manager to join our team based in Witney, Oxfordshire. Your experience Degree qualified and bring a breadth of experience across both operational and strategic procurement in the manufacturing environment. You have CIPS and/or Project Management certifications are advantageous but not essential.You are a self-starter/results focused individual who brings the ability to build effective relationships with colleagues and other functional teams, and excellent interdisciplinary, intercultural, influence/negotiation and networking skills. You are adept at managing change, with experience gained in a large sized organisation, and comfortable managing teams at the strategic level. Your new responsibilities The Procurement Manager will be accountable for leading and developing the procurement process to support both UK and Ireland operations. Driving ownership and accountability in your team, the focus will be on supporting the ongoing development of both process and people, whilst delivering on large upcoming tender opportunities, on-time, and on-budget.Responsible for the management of strategic relationships, both internally and externally, you will be experienced in both Direct Material and Indirect procurement, and able to implement the business vision for Indirect Procurement.Leading a team of 5 direct reports, you will develop and deploy our vision and strategy with amulti-year roadmap to establish the function in the European sites and ensure implementation and leverage of best practices and compliance across all purchasing areas.You will continually look for opportunities for cost reductions, cost avoidance and provision of overall value improvements, whilst measuring and tracking team performance.Focusing on motivating factors to develop the strong team already in place in Witney, you will establish processes and standards that will elevate the procurement team. With a focus on talent development, coaching, and mentoring, you will build skills in the people of the team and support continued delivery of business objectives.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
      JOB TITLE: Procurement ManagerSTART DATE: ASAPContract: 12 Months - Perm PotentialPAY RATE: £75,000+ Per Annum LOCATION: Witney, Oxfordshire - Hybrid The Client Specialising in the emerging market of medical devices and diagnostics agents. Our client has a large product area in Diabetes, Arthritis, Spesis, Pregnancy and many more. They are a global client that makes and sells technologically advanced devices that are used within hospitals, homes and other private groups. The Project Due to continued business growth and internal progression, we have an exciting opportunity for a Procurement Manager to join our team based in Witney, Oxfordshire. Your experience Degree qualified and bring a breadth of experience across both operational and strategic procurement in the manufacturing environment. You have CIPS and/or Project Management certifications are advantageous but not essential.You are a self-starter/results focused individual who brings the ability to build effective relationships with colleagues and other functional teams, and excellent interdisciplinary, intercultural, influence/negotiation and networking skills. You are adept at managing change, with experience gained in a large sized organisation, and comfortable managing teams at the strategic level. Your new responsibilities The Procurement Manager will be accountable for leading and developing the procurement process to support both UK and Ireland operations. Driving ownership and accountability in your team, the focus will be on supporting the ongoing development of both process and people, whilst delivering on large upcoming tender opportunities, on-time, and on-budget.Responsible for the management of strategic relationships, both internally and externally, you will be experienced in both Direct Material and Indirect procurement, and able to implement the business vision for Indirect Procurement.Leading a team of 5 direct reports, you will develop and deploy our vision and strategy with amulti-year roadmap to establish the function in the European sites and ensure implementation and leverage of best practices and compliance across all purchasing areas.You will continually look for opportunities for cost reductions, cost avoidance and provision of overall value improvements, whilst measuring and tracking team performance.Focusing on motivating factors to develop the strong team already in place in Witney, you will establish processes and standards that will elevate the procurement team. With a focus on talent development, coaching, and mentoring, you will build skills in the people of the team and support continued delivery of business objectives.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
      • maidenhead, south east
      • contract
      • £60.00 - £80.00, per hour, Depending on experience
      • randstad cpe
      As the Global Labelling Lead, you would be responsible for developing the strategy and leading the development and update of core labelling documents and for overseeing implementation at a local and regional level. Specifically:Leading the development of a Target Label Profile for a development productLeading the development of the internal process for TLPLeading the Core Data Sheet updates for several approved products What You'll DoCreate and update core labelling documents:Lead timely creation/management of regulatory compliant, competitive and up to date core labelling documents throughout the product life cycle Lead cross functional product Global Labelling Team to reach consensus on core labelling matters, accurately capture and communicate decisions, and obtain endorsement by senior management To be considered for this role, you will have:5 years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labellingSolid knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug developmentProven experience with document management and regulatory tracking systemsProven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impactsMust Have Core Data Sheet experince 6 Month Contract, based in Maidenhead. Start June 2022.Full time - 37.5 hours per weekUmbrella or PAYE. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
      As the Global Labelling Lead, you would be responsible for developing the strategy and leading the development and update of core labelling documents and for overseeing implementation at a local and regional level. Specifically:Leading the development of a Target Label Profile for a development productLeading the development of the internal process for TLPLeading the Core Data Sheet updates for several approved products What You'll DoCreate and update core labelling documents:Lead timely creation/management of regulatory compliant, competitive and up to date core labelling documents throughout the product life cycle Lead cross functional product Global Labelling Team to reach consensus on core labelling matters, accurately capture and communicate decisions, and obtain endorsement by senior management To be considered for this role, you will have:5 years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labellingSolid knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug developmentProven experience with document management and regulatory tracking systemsProven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impactsMust Have Core Data Sheet experince 6 Month Contract, based in Maidenhead. Start June 2022.Full time - 37.5 hours per weekUmbrella or PAYE. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

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