REMOTE Global Labeling Lead Consultant - CCDS, SmPC, USPIs

Job Description

ClinChoice is seeking a Global Labeling Lead Consultant for a 12-month remote contract. The consultant will work directly for a single sponsor while benefiting from the security and career opportunities of a global CRO. This role involves initial creation and updates to labeling documents, driving strategy, and ensuring compliance with regulatory requirements.

Responsibilities include:
• 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 related to US and EU labeling.
• Managing projects from request to stakeholder notification.
• Acting as the primary point of contact for labeling team members.
• Reviewing and approving labeling documents to ensure compliance.
• Collaborating with cross-functional teams.
• Monitoring industry trends and regulatory changes.
• Providing expert advice on labeling requirements and best practices.

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

ClinChoice offers:
• Opportunity to work directly with a major pharmaceutical client.
• A supportive and collaborative work environment.
• Professional development opportunities.