Senior Specialist, Labeling

Label Strategist

The purpose of the Label Strategist is to drive labeling strategy and provide high-quality and compliant labeling documents, ensuring the safe and effective use of products for patients and healthcare providers globally. The Label Strategist is accountable for developing and maintaining the target product labeling for developmental products, the core labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and most of the world labeling.

The Label Strategist is responsible for managing labeling of assigned products for developmental and marketed products, globally. This includes collaboration with the cross-functional labeling team to develop and maintain the core labeling and US labeling, including associated patient labeling documents, and the target product labeling. The Label Strategist is also responsible for supporting local country affiliates on the development and maintenance of the EU and most of the world labeling.

Responsibilities

• Is accountable for initial creation and updates of labeling documents for company products, including core, US and supporting country regulatory affiliates for consistency of labeling documents around the world.
• Works cross-functionally and leads meetings to develop, review and approve labeling documents to ensure consistency and the safe and effective use of products around the world.
• Operates as the primary point of contact on assigned products for all internal and external stakeholders to ensure timely regulatory submissions, quality and compliant labeling documents, and to support business objectives. Includes support required for audits / inspections related to assigned products.
• Provides project management throughout the entire process, from the request to update Core / US labeling through notification to stakeholders, to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements.
• Ensures that country labeling documents are aligned with the core or reference labeling documents.
• Controls the consistency of US labeling content through alignment with the Core Labeling, across product families where necessary, and with all applicable best practices and regulatory requirements.
• Leads the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
• Manages communication plans, distribution of labeling documents, updates to labeling tracking reports and databases, and provides status updates to Global Labeling management.
• Provides regulatory expertise and guidance for the development and submission of US labeling components.
• Assists with creation / update of local product labeling (EU and most of world) for assigned products and interfaces with local country affiliate colleagues to support timely and quality regulatory submissions and approvals globally.

Required Education, Experience and Skills

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our vision is clear : A better and healthier every day for every woman.