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Global Labelling Lead
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Proclinical Staffing City of London, United KingdomJob DescriptionAbout This Role · The purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally. ...
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Global Labelling Lead
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Proclinical Staffing City of London, United KingdomAbout This RolenThe purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally. · As the Global L ...
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Global Labelling Lead
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Proclinical Staffing City of London, Greater London, United KingdomBefore applying for this role, please read the following information about this opportunity found below.About This Role The purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the ...
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Proclinical Staffing City of London, Greater London, United KingdomThe purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally. · As the Global Labelling Lead, ...
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Proclinical Staffing City of London, Greater London, United KingdomIs your CV ready If so, and you are confident this is the role for you, make sure to apply asap. · The purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective us ...
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Proclinical Staffing City of London, Greater London, United KingdomAbout This Role The purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally.As the Global Labe ...
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Team Lead
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Proclinical Group City of London, Greater London, United KingdomPhone Number * · Proclinical is committed to protecting and respecting your privacy, and we'll only use your personal information to administer your account and to provide the products and services you requested from us. From time to time, we would like to contact you about our ...
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Global Labelling Lead - City of London, Greater London, United Kingdom - Proclinical Staffing
Description
About This Role The purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally.
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.
What You'll DoCreate and update core labelling documents:
Lead the timely creation/management of regulatory compliant, competitive and up to date core labelling documents throughout the product lifecycle including the Company Core Data Sheet (CDS), Global Patient Leaflet and Target Label ProfileLead cross functional product Global Labelling Team to reach consensus on core labelling matters, accurately capture and communicate decisions, and obtain endorsement by senior managementPropose the strategy to be followed in core labelling documents, ensuring alignment with global regulatory strategiesOversee distribution and tracking of CDS updates, ensuring compliance is maintained within the EDMS and the Regulatory Tracking System Oversee regional implementation:Oversee timely implementation of CDS updates in regional labels and monitor compliance to labelling processesSupport Regional and Local Regulatory Leads in responding to Health Authority queries related to labelling and collaborate with Regulatory Leads to identify and track Country Labelling DifferencesCore labelling supporting documentation:Oversee preparation of supporting documents for core labelling changes, in collaboration with Medical Writing, ensuring alignment to the core labelling strategy and global regulatory strategyMaintain labelling complianceMaintain labelling compliance for assigned products ensuring version control and tracking of CDS implementation in relevant company systemsCreate, maintain and update regulatory labelling procedures and SOPs and support relevant audits and inspectionsMaintain knowledge of current rules and regulations governing global labelling activitiesProvide training to internal stakeholders, new joiners on labelling process requirements and content standardsBasic to advanced level of skill in key labeling capabilities including:Understand scientific concepts to critically assess clinical data, enable proactive interactions with appropriate stakeholders, influence the clinical development planDevelop and implement strategy for global labeling contentIdentify underlying processes and principles for developing product claims representing the risks and opportunities to the project teamPartner with key stakeholders to ensure product labeling is the most current, accurate, relevant and competitive to inform prescribers and patientsProvide tactical guidance to product labeling review teams regarding labeling content developmentRecognize potential regulatory issues, solutions and opportunitiesShows the value labeling brings to the business by owning labeling content Required Skills3 to 7 years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labellingProven experience with document management and regulatory tracking systemsDemonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterpartsDemonstrate strong organizational skills, including the ability to prioritize personal workloadAbility to deal effectively with a variety of personnel including medical, scientific, and manufacturing staffStrong sensitivity for a multicultural/multinational environmentWell organized, detail oriented, highly effective written and oral communication skills Preferred SkillsBachelor's degree in a scientific or medically related discipline preferredProclinical 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.
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