• 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.
• Ability to recognize and escalate issues
• Managing and Measuring Work
• Presentation Skills
• Interpersonal Skills
At Otsuka, we defy limitation, so that others can too.
We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.
Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.