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Otsuka Pharmaceutical Companies (U.S.) · 2 hours ago

Director, Global Labeling Strategy

Princeton, NJ

Full-time

Onsite

Director/Executive

$183K/yr - $274K/yr

10+ years exp

Otsuka Pharmaceutical Companies (U.S.) is focused on driving innovation in the pharmaceutical industry. The Director of Global Labeling Strategy will lead the development and execution of labeling strategies, ensuring compliance with regulations and providing leadership to cross-functional teams.

Health CareMedical

Comp. & Benefits

Responsibilities

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

Qualification

Pharmaceutical Labeling ExperienceRegulatory Affairs KnowledgeCCDSUSPI WritingMedical TerminologyRegulatory ComplianceProject ManagementClient-Driven ApproachLeadershipCommunication SkillsTeam CollaborationProblem Solving

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

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