Global Labeling Specialist (Operations)

Job Description

Global Labeling Specialist (Operations)

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1+ year contract with high probability of extensions

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About This Role

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The purpose of the Global Labeling group is to drive the client’s labeling strategy and ensure that labeling 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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As the Global Labeling Specialist (Operations), you will be responsible for:

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• Artwork coordination between Regulatory/Labeling and Artwork/Change Management teams
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• Structured Product Labeling (SPL) management
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• Supporting the development and maintenance of core, EU and/or US labeling documents
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• Tracking core labeling implementation at a regional/country level
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What You’ll Do

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Labeling Operations:

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• Act as intermediary between Regulatory/Labeling and Artwork/Change Management Teams to ensure changes to the planned artwork activity and implementation timelines are communicated
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• Record regulatory assessments and ensure Change Management System is appropriately linked to the Regulatory Tracking System
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• Support the Regulatory/Labeling team to provide the SPL version of the USPI to the FDA via a vendor
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Create and update labeling documents:

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• Support the development/maintenance of regulatory-compliant, competitive and high-quality labeling documents throughout the product lifecycle, including the Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI) and US Prescribing Information (USPI)
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• Support the cross-functional product labeling team on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management
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• Distribute and track CDS updates, maintaining compliance within the Electronic Document Management System and the regulatory tracking system
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• Support the delivery of EUPI and USPI according to company strategy, Health Authority regulations and timelines
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Oversee regional/country implementation:

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• Track implementation of CDS updates, maintaining compliance within the EDMS and the Regulatory Tracking System
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• Support Regional and Local Regulatory Leads in responding to Health Authority queries related to labeling and collaborating with Regulatory Leads to identify and track Country Labeling Differences
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Maintain labeling compliance

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• Maintain labeling compliance, ensuring version control and tracking of labeling documents in relevant company systems
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• Create, maintain and update regulatory labeling procedures and SOPs and support relevant audits and inspections
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• Maintain knowledge of current rules and regulations governing global labeling activities
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• Provide training to internal stakeholders and new joiners on labeling process requirements
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Who You Are

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You will have a passion for regulatory labeling and an excellent eye for detail. You will also have a demonstrated understanding of the importance of labeling governance and compliance.

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Required Skills

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• 3+ years pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations supporting innovative medicines
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• Direct experience with products developed through the full drug development and registration lifecycle in an innovator company environment
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• Knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development
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• Proven experience with document management, regulatory tracking and change management systems
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Preferred Skills

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• Bachelor's degree in a scientific or medically related discipline preferred
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