Position Summary

Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components.Provides leadership, people management and tactical input on the planning and execution of labeling initiativesFormulates improvements to labeling policies, processes, quality, and system tools.Lead continuous improvement efforts of the end-to-end labeling processDevelop and implement strategies to enhance global labeling awareness and trackingDemonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies.Support inspection readiness activities related to all global labeling componentsMay 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 strategiesUnderstand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategiesAssess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussionsSupport global HA interaction strategy to discuss key labeling elementsDuring HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategiesDevelop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval

Key job responsibility

Ensures all labeling components (for new and existing product labels and labeling) are appropriately developed and maintained according to relevant laws and regulations – including the response to labeling request changes in an efficient manner to meet required timelines.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.Present to Labeling Oversight Committee: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile.Follows and formulates improvements to labeling policies, processes, quality, and system tools.Ensure policies and practices are maintained so that local labels are consistent with global labeling.Contribute, develop & implement solutions to build awareness and global strategic mindsetSupport all tracking, planning and storage activities related to labeling including any computer or manual system related activitiesSupport inspection readiness activities related to all global labeling componentsAnalyses 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.

Knowledge, Skills, and Competencies

Solid understanding of global labeling regulatory requirements and industry practiceSolid understanding of medical concepts and terminologyStrong written and oral communication skillsExcellent computer skills including experience with Regulatory Information Management System (RIMS), EDMS, XML including SPL systems and MS Office: Word, Excel, PowerPoint, SharePoint and OutlookAbility to generate problem solving innovative solutions and motivate others to be innovativeAbility to recognize and escalate issuesManaging and Measuring WorkPresentation SkillsInterpersonal and Negotiation Skills

The ideal candidate should be action oriented, customer focused, able to manage workloads, set priorities, and have demonstrated the ability to build effective teams. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams and show strong business acumen.

Education and Related Experience Required

PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.10+ years of relevant experience in pharmaceutical regulatory/labeling environment.Experience writing CCDS and USPI documents for new products.Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.

Physical Demands and Work Environment

Travel (approximately 10%)

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:  

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

 

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

 

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

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