Senior Global Labeling Expert
Vor 4 Tagen
This Senior Global Labeling Expert role is an exciting opportunity to join our team at Aequor Consulting GmbH. As a seasoned professional in global labeling activities, you will be responsible for leading all labeling-related activities and ensuring compliance with regulatory standards.
Your primary focus will be on maintaining up-to-date global labeling documents, including Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS) for assigned products. You will present proposed CDS changes to the Global Labelling Committee (GLC) and organize the Expert Labelling Task Force (ELTF) to define labeling strategies and finalize labeling texts.
In this role, you will represent Global Labelling (GL) in Regulatory Affairs (RA) Sub-teams and Safety Management Teams (SMTs). Conducting research on labeling topics, including competitor labels, regulatory requirements, and market-specific variations, is a crucial aspect of this position. You will develop high-quality documents supporting CDS updates and responses to health authority inquiries.
Collaboration with country organizations (COs) is essential to ensure timely and compliant implementation of global labeling changes. The position requires support for regulatory activities related to safety risk communications and portfolio stewardship. Leading or contributing to labeling-related presentations at key committees and forums is also a key responsibility.
To succeed in this role, you will need to possess a strong understanding of medical and scientific terminologies, as well as a good grasp of drug safety information. Strong interpersonal, project management, communication, negotiation, and problem-solving skills are also essential.
Responsibilities- Lead labeling-related activities: Ensure compliance with regulatory standards.
- Maintain global labeling documents: Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS) for assigned products.
- Present CDS changes: To the Global Labelling Committee (GLC).
- Organize ELTF: Define labeling strategies and finalize labeling texts.
- Represent GL: In Regulatory Affairs (RA) Sub-teams and Safety Management Teams (SMTs).
- Conduct research: On labeling topics, including competitor labels, regulatory requirements, and market-specific variations.
- Develop high-quality documents: Supporting CDS updates and responses to health authority inquiries.
- Collaborate with COs: Ensure timely and compliant implementation of global labeling changes.
- Support regulatory activities: Related to safety risk communications and portfolio stewardship.
- Lead or contribute to presentations: At key committees and forums.
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