Global Labeling Lead Consultant - CCDS, SmPC, USPIs

As the Pharmaceutical Global Labeling Lead (GLL), you will be responsible for initial creation and related updated to labeling documents for assigned projects. You will be responsible for driving 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. You will play a crucial role in ensuring compliance with regulatory requirements and delivering high-quality labeling solutions to our clients. Provide strategic support and leadership to the labeling team, providing guidance, coaching, and feedback. Guide the labeling team to develop and maintain Company Core Data Sheets (CCDS), Package Inserts (PI), Summary of product Characteristics (SPC), and their associates patient labeling documents. Keep up-to-date with labeling guidelines and regulations related to the development and maintenance of US and EU labeling. Provide project management to the labeling team throughout the process from request to stakeholder notification. Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines.