(US - REMOTE) Global Labeling Lead Consultant - CCDS, SmPC, USPIs

Job Description

ClinChoice is seeking a Global Labeling Lead Consultant to join one of their pharma clients. This is a client-facing role that requires a confident individual who can work independently and establish a high-trust environment with the client's counterparts. The role is remote-based in the US.Responsibilities:

• Providing strategic support and leadership to the labeling team.
• Guiding the team in developing and maintaining Company Core Data Sheets (CCDS), Package Inserts (PI), Summary of Product Characteristics (SPC), and associated patient labeling documents.
• Keeping up-to-date with labeling guidelines and regulations related to US and EU labeling.
• Providing project management to the labeling team.
• 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.
• Collaborating with clients and providing expert advice.

Requirements:

• Bachelor's degree in a scientific or related field (Advanced degree is a plus).
• Minimum 7 years of experience in pharmaceutical labeling operations within a pharmaceutical industry setting.
• Strong knowledge of regulatory requirements and guidelines (FDA, EMA, ICH).
• Demonstrated knowledge of CCDS.
• Excellent project management skills.
• Strong attention to detail and accuracy.
• Effective leadership and team management abilities.
• Proven problem-solving skills.
• Proficiency in Microsoft Office Suite.
• Excellent oral and written communication skills.

The role offers:

• Opportunity to work directly for a single sponsor while having the security of a global CRO.
• Professional development and a supportive culture.
• Remote work option.