REMOTE Global Labeling Lead Consultant - CCDS, SmPC, USPIs

Job Description

ClinChoice is seeking a Global Labeling Lead Consultant to work directly for 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.As the Global Labeling Lead, the consultant will be responsible for the creation and updates of labeling documents for assigned projects. They will drive strategy by providing guidance and advising the Labeling Team on internal labeling policies, raising awareness of key factors to consider when revising labels, 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 related to US and EU labeling.
• Acting as the primary point of contact for the labeling team members.
• Reviewing and approving labeling documents to ensure compliance.
• Collaborating with cross-functional teams.
• Monitoring industry trends and regulatory changes.

Requirements:

• Bachelor's degree in a scientific or related field (Advanced degree is a plus).
• 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 for a major pharmaceutical client.
• Chance to contribute to a global CRO.