Associate Director, Global Labeling
Otsuka America Pharmaceutical Inc.
Atlanta, GA
Job SummaryResponsible for working with cross-functional teams across the organization to drive and align the development and maintenance of global labeling (e.g. CCDS, regional product labels, and patient labeling) for assigned compounds. Makes recommendations and provides labeling advice and feedback for labeling content, processes, and timelines to ensure compliance with labeling regulations and guidance. Delivers high-quality submission labeling and artwork for complex drug products, specific therapeutic/disease areas, and cross functional teams. Actively contributes to continuous improvement of end-to-end labeling processes and systems.Job DescriptionAct as Global Labeling Strategy Lead, supporting preparation, review, and update of content for the development and maintenance of Company Core Data Sheet (CCDS), local labeling and labeling components.Lead the cross-functional labeling team for assigned compounds to drive alignment of labeling content and strategy.Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging.Evaluate and communicate risks associated with CCDS content updates and implementation strategies.Drive labeling for package labeling (artwork) development, update, and maintenance through collaboration with a cross-functional team.Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations.Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant.Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labelingSupport creation, compliance, update, and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment Directory, etc).Manage and maintain labeling documents in document management systems; Manage label review and approval.Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.).Support inspection readiness activities related to all global labeling components.Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed.Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval.Review and propose continuous improvements to Global Labeling policies, end-to-end processes, quality, and system tools.May be assigned additional responsibilities, as deemed necessary.QualificationsRequiredMS/BS in life sciences or other scientific field.6-8 years of relevant experience in pharmaceutical regulatory/labeling environment and/or drug developmentKnowledge of scientific principals and regulatory systems, relevant to drug developmentExperience writing CCDS and local labeling documents for new products.PreferredKnowledge and skillsSolid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance requiredSolid understanding of implications of global labeling across the organization and globallySolid understanding of the structure of product labelingExperience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneouslyAbility to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company.Effective written and oral communication and organizational skillsStrong attention to detailSolid 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 applicationsAbility to think strategically, communicate risks, and recommend problem solving innovative solutionsAbility to recognize and escalate issuesThe ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams.CompetenciesAccountability 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 $164,530.00 - Maximum $245,985.00, plus incentive opportunity:The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.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 .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 (EEAccommodations@otsuka-us.com) .Statement Regarding Job Recruiting Fraud ScamsAt 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.
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