Labeling Group Lead 9/8/2016
* Independently works or directs staff member(s) in the preparation, reviews, revisions, and approvals of content that are required for development and maintenance of labeling and label components including for container and carton labels.
* Utilizes regulatory/product/therapeutic area knowledge to provide support and strategic input in structuring labeling components, and ensures that labeling materials meet regulatory and company requirements, and timelines.
* Contributes to and ensures implementation of global labeling product development strategy including the development of target product profiles per product development plan.
* Responsible for the creation, development, and maintenance of primarily internal use labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (USPI, Med Guide, SmPC, PIL, Canadian Monograph, Instructions for Use). This is done in conjunction with multidisciplinary teams which include members from CMC, preclinical, clinical, clinical pharmacology, pharmacovigilance (PV), etc.
* Coordinates the review and approval of internal use and outward facing labeling documents (by the relevant labeling review committees (Cross-functional Labeling Team and Committee)
* Leads and directs activities related to the updating, implementing and enhancing the Global Labeling system and its usage
* Closely collaborates with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provides labeling to Advertising and Promotion, for marketing pieces, and works with Commercial for website postings
* Ensures the dissemination and tracking of approved labelling documents and supporting documentation.
* Follows FDA postings on websites e.g. DailyMed, Drugs@FDA. Supports drugs listing and establishment registration.
* Ensures quality of labelling deliverables i.e., alignment of labelling text with data and regional regulatory requirements, consistency between labelling documents and QC of labels and labelling
* Contributes to the continuous improvement of the end-to-end labelling process
* Global Labeling system
* Enhancements of complete labelling process in collaboration with Japan and other regional groups.
* Ensures that all labelling components (for new and existing product labels and labelling) are appropriately developed and maintained according to relevant laws and regulations.
* Responds to labelling request changes in an efficient manner to meet required timelines.
* Analyses and interprets new regulations and Guidances as well as monitors and determines their impact on product labelling.
* Manages contracts for contractors and consultants
* Monitors and informs others of changes in US labelling regulations as well as corporate policies and procedures, as appropriate.
* Solid understanding and interpretation of US regulatory requirements
* Well versed in clinical medicine and clinical pharmacology
* Solid understanding of the structure and function of the product labelling, drug development process
* Global Business Knowledge
* Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, and Outlook and Adobe products including: Acrobat, InDesign and Illustrator.