Director, Global Labeling Strategy

Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), Target Product Label, 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 sub team 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 Strategy experience.
• Thorough understanding of scientific principals and regulatory systems, relevant to drug development.
• Experience writing CCDS, TPL 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.

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.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives.  They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov,  or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.