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REMOTE Global Labeling Lead Consultant - CCDS, SmPC, USPIs

Global Labeling Lead Consultant for pharmaceutical client, remote option.
ClinChoice
Remote
Poland
Undisclosed salary
Job Description
ClinChoice is seeking a Global Labeling Lead Consultant to work directly with a major pharmaceutical client on a 12-month contract basis. This role offers a remote work option and the opportunity to contribute to a global CRO with a focus on quality and professional development. The Global Labeling Lead (GLL) will be responsible for the creation and updates of labeling documents, driving strategy, and ensuring compliance with regulatory requirements.

Role involves:
  • Providing strategic support and leadership to the labeling team.
  • Guiding the team in developing and maintaining Company Core Data Sheets (CCDS), Package Inserts (PI), and Summary of Product Characteristics (SPC).
  • Keeping up-to-date with labeling guidelines and regulations.
  • Managing labeling projects from request to stakeholder notification.
  • Acting as a reviewer and approver of labeling documents.
  • Collaborating with cross-functional teams.
  • Monitoring industry trends and regulatory changes.
  • Providing expert advice and guidance on labeling requirements.

Requirements:
  • Bachelor's degree in a scientific or related field.
  • Minimum 7 years of experience in pharmaceutical labeling operations.
  • Strong knowledge of regulatory requirements and guidelines (FDA, EMA, ICH).
  • Demonstrated knowledge of CCDS and labeling team objectives.
  • Excellent project management skills.
  • Strong attention to detail and accuracy.
  • Effective leadership and communication skills.
  • Proficiency in Microsoft Office Suite.

Role offers:
  • Remote work option.
  • Opportunity to work directly with a single sponsor.
  • Career opportunities within a global CRO.
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ClinChoice

ClinChoice is a global provider of regulatory and scientific services, specializing in preparing and submitting compliant Material Safety Data Sheets (MSDS/SDS). The company supports multinational chemical manufacturing companies, offering hazard analysis, SDS authoring, and regulatory compliance expertise across US, EU, and other international markets. ClinChoice focuses on establishing structured processes for SDS preparation, and delivers comprehensive hazard assessments and SDS phrases based on global regulatory standards. They provide mentorship and review services.

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