Global Labeling Lead Consultant - CCDS, SmPC, USPIs - Remote

Overview

As a Global Labeling Lead Consultant, you will work directly with a major pharmaceutical client, providing strategic support and leadership in the development and maintenance of labeling documents. This role requires a deep understanding of regulatory compliance and the ability to guide a labeling team effectively.

In Short

• Work remotely for a global CRO while collaborating with a single pharmaceutical sponsor.
• Lead the labeling team in creating and updating labeling documents.
• Ensure compliance with regulatory requirements.
• Provide project management support throughout the labeling process.
• Act as the primary point of contact for labeling team members.
• Monitor industry trends and regulatory changes in pharmaceutical labeling.
• Collaborate with cross-functional teams including Regulatory Affairs and Quality Assurance.
• Train and guide other Global Labeling Leads as needed.
• Contribute to business strategy and client engagement.
• Deliver high-quality work that meets client expectations.

Requirements

• Bachelor's degree in a scientific or related field; advanced degrees preferred.
• Minimum 7 years of experience in pharmaceutical labeling operations.
• Strong knowledge of FDA, EMA, and ICH guidelines.
• Excellent project management skills.
• Strong attention to detail and accuracy.
• Effective leadership and communication skills.
• Proficiency in Microsoft Office Suite.
• Ability to manage multiple projects simultaneously.
• Demonstrated problem-solving skills.
• Ability to liaise effectively with stakeholders.

Benefits

• Work with a global team in a supportive culture.
• Opportunities for professional development.
• Engage in meaningful work that contributes to health and safety.
• Flexible working arrangements.
• Inclusive and diverse workplace.