Senior Manager, Global Labeling Compliance – Connectivity

Posted 17ds ago

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Job Description

Senior Manager overseeing global labeling compliance and connectivity at biotech firm. Driving compliance initiatives and supporting labeling process improvements in the global regulatory team.

Responsibilities:

  • Monitor and update labeling provision of SDEA labeling contracts
  • Conduct data remediation activities
  • Drive cross-functional working groups to identify process efficiencies
  • Assist with development, revision, and maintenance of departmental SOPs
  • Prepare training and communication for stakeholders
  • Report on metrics and KPIs for labeling process compliance
  • Serve as strategic regulatory partner and liaison with IT

Requirements:

  • Minimum 6 years pharmaceutical or industry related labeling experience
  • Direct working experience with labeling process and document management
  • Strong aptitude for authoring documentation
  • Familiarity with Regulatory Information Management systems
  • Effective communication skills (verbal and written)
  • Strong organizational skills
  • Proficiency in MS Office and Project Management tools

Benefits:

  • Professional development opportunities

BeOne Medicines

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