Sr Manager/Team Lead, Labeling Operations

ROLE SUMMARY:

The Labeling Operations Manager/Team Lead will provide back up to Global & International Labeling Operations Head and will serve as a Global Labeling, Artwork, and U.S. Advertising & Promotion subject matter expert in areas related to general above country labeling operations. Will train and provide guidance and mentorship to other Labeling Operations Managers. The senior manager/team lead LOM will have direct reports or oversight of contractors and/or vendors. The Senior Manager/Team Lead LOM will have accountability for setting direction, leading pay, performance, goal setting, and development discussions for direct reports and manage vendor or contractor relationships for those contractors/vendors under their direct supervision.

The Labeling Operations Manager (LOM) will lead and provide operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. The Labeling Operations Manager, Senior Manager/Team Lead is capable of managing a large volume of projects which can be highly complex, including new development -NCE/NME, product enhancements, and updates that require extensive labeling discussions.

The LOM can lead teams tasked with development of continuous improvement of business practices and/or technology innovations. The LOM will be a change champion and advocate for new labeling initiatives to labeling stakeholders across the portfolio and across the organizations.

ROLE RESPONSIBILITIES:

Lead and manage the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. Serve as the subject matter expert in areas related to general above country labeling operations. The Labeling Operations Manager, Senior Manager/Team Lead is capable of managing a large volume of projects which can be highly complex, including new development -NCE/NME, product enhancements, and updates that require extensive labeling discussions.

The LOM will provide operational support:

• Edit and format labeling documents according to internal and external guidance.

• Independently manage updates for related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.

• Prepare comparison tables for labeling team discussions.

• Coordinate and manage the Quality review process ensuring timelines are met and drive right first time principles. 

• Generate necessary renditions (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.

• Communicate with and notify key stakeholders of the labeling updates and/or availability of labeling documents.

• Create content of labeling xml (e.g. SPL for USPIs) and coordinate meta data/artwork sections with supporting lines.

• Draft/update related labeling document updates e.g., for products within a similar class, of different dosage forms, and for generics.

• Set clear targets for review and approval timelines for labeling documents using effective project management.

• Communicate with stakeholders to ensure deadlines are met.

• Consolidate and coordinate multiple labeling versions with different submission or HA review status.

• Responsible for ensuring compliance to Company’s submission standards, policies and procedures.

• Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.

The Senior Manager/Team Lead, LOM will provide the following leadership support:

• Have direct accountability for onboarding, training, goal setting, deployment, and leading pay, performance, and development discussions of the direct reports.

• Have direct accountability for onboarding, training, and deployment, of the vendors and/or contractors under their responsibility.

• Manage vendor or contractor relationships for those contractors/vendors under their direct supervision.

• Promote the development of, and training opportunities for, the direct report/junior personnel, vendors and/or contractors as required.

• Responsible for project monitoring and ensuring that LOM tasks are performed per quality expectations, as per target timelines & in compliance with company standards, policies and procedures.

• Identify and direct teams to overcome barriers in achieving quality and compliance.

• Guide and as