REMOTE Global Labeling Lead Consultant- CCDS, SmPC, USPIs

Job Description

ClinChoice is seeking a Global Labeling Lead Consultant for a 12-month contract with a remote option, to join one of its major pharmaceutical clients. The Global Labeling Lead (GLL) will be responsible for the creation and updates of labeling documents for assigned projects. He/She will drive strategy through guidance and advising of the Labeling Team on internal labeling guidance and policies and will raise awareness of key factors to consider when revising labels. The GLL will ensure that the impact on Country Labeling Documents is considered during labeling discussions and will advise the labeling team on the content of other labels in the same therapeutic class. He/She will play a crucial role in ensuring compliance with regulatory requirements and delivering high-quality labeling solutions.

• Providing strategic support and leadership to the labeling team.
• Guiding the labeling team to develop and maintain Company Core Data Sheets (CCDS), Package Inserts (PI), Summary of product Characteristics (SPC), and their associated patient labeling documents.
• Acting as the primary point of contact for the labeling team members and provide day-to-day direction to Labeling Operations Managers.
• Acting as a reviewer and approver of labeling documents.
• Collaborating with cross-functional teams.
• Monitoring industry trends and regulatory changes.
• Collaborating with clients and provide expert advice and guidance on labeling requirements.

• Bachelor's degree in a scientific or related field.
• Minimum 7 years of experience in pharmaceutical labeling operations within a pharmaceutical industry setting.
• Strong knowledge of regulatory requirements and guidelines related to pharmaceutical labeling, including FDA, EMA, and ICH guidelines.
• Excellent project management skills.
• Effective leadership and team management abilities.
• Excellent oral and written communications skills.

• Opportunity to work directly for a single sponsor while having the security and career opportunities of a global CRO.
• Remote work option.