Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local labeling from early-stage development through to product maintenance. Facilitate strategic development of labeling and labeling components, by leading a diverse cross-functional labeling subteam through discussion and decisions. Evaluate and communicate strategies and anticipate risks associated with CCDS content updates and implementation. Key role of providing labeling leadership, mentoring peers, driving strategic label development and execution of core labeling information.
Job Description
- Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide.
- Leads or contributes to cross functional teams: Labeling Committees, Labeling Teams, and provide direction and support to Product Review Council teams, Legal and other groups, as needed.
- Develop and maintain Target Product Label, Company Core Data Sheet (CCDS) and local labels.
- Ensure that all labeling (for development and marketed products) is appropriately developed and maintained according to relevant laws and regulations.
- High-level understanding of the dynamics and purpose of the Target Product Label and CCDS and the associated implications on labeling globally.
- Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
- Ability to assess regional labeling to ensure compliance with CCDS.
- Assess competitor labeling - understanding precedents & opportunities.
- Ability to assimilate key clinical, scientific, and medical information and present it in a concise manner.
- Ability to understand and address payer needs and commercial differentiation strategies.
- During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies.
- Support global HA interaction strategy to discuss key labeling elements.
- Lead response to Health Authority (HA) questions for labeling. Respond to labeling related inquiries from global Health Authorities in an efficient manner to meet required timelines.
- Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval.
- Present to Global Labeling Review Team: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile.
- Ensure that deliverables are met, and labeling claims are consistent across programs.
- Develop and implement strategies to enhance global labeling awareness – use of core data sheets, strategic global mindset.
- Support all tracking, planning and storage activities related to labeling, including any computer or manual system related activities.
- Follow 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.
- Analyze and interpret new regulations and Guidance, as well as monitor and determine impact on product labeling. Identify opportunities to influence regulatory policy and climate.
- Provide strategic advice on implementing new regulations, as well as providing input for development of promotional messages, as needed.
- Contribute to the continuous improvement of the end-to-end labeling process and support labeling inspection / audit readiness activities.
- Provide leadership and mentoring to team members and motivate others to be innovative.
- May be assigned additional responsibilities, as deemed necessary.
Qualifications
Required
- BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
- 10+ years of relevant pharmaceutical Labeling/Regulatory experience.
- Thorough understanding of scientific principals and regulatory systems, relevant to drug development.
- Experience writing CCDS and USPI documents for new products.
Preferred
Knowledge and skills
- Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice.
- Exceptional understanding of medical concepts and terminology.
- Strong written and oral communication skills, including presentation skills.
- Considerable experience in managing high to medium complex projects.
- Strong aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; willing to learn additional applications.
- Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.
- Proven matrix leader with excellent problem-solving innovative solutions.
- Demonstrated ability to provide leadership and development for junior team members.
- Solid ability to recognize and escalate issues.
- The ideal candidate should be action oriented, client-driven, ability to manage workloads and set priorities and 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.
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.
Application Deadline: This will be posted for a minimum of 5 business days.
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.
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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Top Skills
What We Do
There are two Otsuka pharmaceutical industry companies in the U.S.:
Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America.
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.
