As part of the US Labeling, Advertising and Promotions (Ad Promo) team, and under the supervision of the US Labeling Ad Promo Science Lead, the Labeling Strategist Manager is responsible for the facilitation and management of the end-to-end labeling and artwork processes for pre- and post- marketed products over the product’s lifecycle. The Labeling Strategist Manager will manage the development of the United States Package Insert (USPI) in accordance with company labeling processes for assigned therapeutic area(s).
You like to work in an environment where you can:
• Own the development, review, approval, and maintenance of labeling for designated products. Lead the Cross Functional Labeling Team and manage labeling projects for the USPI and local labeling. This will include active research of competitive labels as well as identifying support for associated promotional claims (80%).
• Actively participate on product development teams to provide labeling leadership and help identify labeling concept targets (5%).
• Mentor junior staff members to help build robust internal labeling expertise (5%).
• Prepare the submission ready labeling documents, including the SPL and packaging artwork. Maintains and tracks labeling documents in the labeling repository and electronic system, as appropriate (5%).
• Maintain expertise in worldwide regulation changes pertaining to labeling regulations and maintain the labeling SOP and work instructions (5%).
You will contribute by:
• Participating in the development of the labeling objectives early in product development to assist teams in creating development strategies.
• In conjunction with regional leads, representing regional and local perspective during the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS).
• Leading the development, review, approval and maintenance of core US labeling documents including Prescribing Information, Medication Guide, Instructions for Use, packaging artwork.
• In conjunction with the US Lead, leading the cross-functional Labeling Team and managing labeling projects for local labeling effectively and independently.
• Providing US strategic guidance on labeling regulations and requirements.
• Assisting in preparation of responses to labeling-related FDA questions (labeling negotiations).
• Supporting development of labeling for HF studies.
• Representing the labeling function on product-specific global regulatory teams.
• Maintaining and appropriately archiving submitted and approved labeling documents and packaging component labeling.
• Assisting in the creation or revision of the labeling SOP or work instructions.