Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components.
They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies.
May be assigned additional responsibilities as deemed necessary.
Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada)
Evaluate and communicate risks associated with CCDS content updates and implementation strategies
Understand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategies
Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions
Understand implications for promotional and HTAs from local labeling
Support global HA interaction strategy to discuss key labeling elements
During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies
Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval
Contributes to the continuous improvement of the end-to-end labeling process
Ensures that all labeling components (for new and existing product labels and labeling) are appropriately developed and maintained according to relevant laws and regulations.
Responds to labeling request changes in an efficient manner to meet required timelines.
Support all tracking, planning and storage activities related to labeling including any computer or manual system related activities
Support inspection readiness activities related to all global labeling components
Follows and formulate improvements to labeling policies, processes, quality, and system tools.
Ensure policies and practices are maintained to ensure local labels are consistent with global labeling
Present to Labeling Oversight Committee: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile.
Leads or contributes to cross functional teams: Labeling Committees, Labeling Teams, and provides direction and support and leadership to Product Review Council teams, Legal and other groups as needed.
Analyses and interprets new regulations and Guidances as well as monitors and determines their impact on product labeling. Provides strategic advice on implementing new regulations as well as provides input for development of promotional messages as needed.
PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.
5+ years of relevant experience in pharmaceutical regulatory/labeling environment. Role level to be determined by years and type of experience
Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.
Solid understanding of global labeling regulatory requirements and industry practice
Excellent understanding of medical concepts and terminology
Strong written and oral communication skills
Strong computer skills including experience with Regulatory Information Management System (RIMS), EDMS, XML including SPL systems and MS Office: Word, Excel, PowerPoint, SharePoint and Outlook
Action oriented, customer focused, ability to manage workloads, set priorities, and ability to build effective teams. Must be able to deal with ambiguity.
Ability to generate problem solving innovative solutions Must deal with ambiguity and be action oriented.