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Principal Global Labeling Specialist
Principal Global Labeling Specialist-March 2024
Arden Hills
Mar 30, 2026
About Principal Global Labeling Specialist

  Additional Location(s):US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. Purpose The purpose of the Principal Global Labeling Specialist (eLabeling) is to be a dedicated electronic labeling (eLabeling) Process Subject Matter Expert (SME), managing the strategy and governance of eLabeling requirements, documentation, and quality system decisions for all BSC divisions and programs. The role will also be the localization operations process SME for eLabeling, along with supporting general Global Labeling needs as part of the Global Labeling Process & Development Team. This role partners heavily with the eLabeling Project Lead, eLabeling Technology Lead, Global Labeling Process Steward, Global RA Ops, and the Global Labeling Process Leads. Responsibilities eLabeling Process Strategist- Develop and drive strategic roadmap for the eLabeling ecosystem, considering the interconnectivity of BSC systems and processes with eLabeling (e.g. Localization, Windchill, Design Controls, Distribution, Regulatory Requirements, PDD, and others). Support Labeling Configuration and Lifecycle Management and the provision of literature electronically. Drive continuous improvement of eLabeling process. Institute the scalability of the eLabeling process in alignment with BSC growth and expansionary goals. eLabeling Compliance owner- Manage the review of new regulations/standards and the integration of new requirements into the BSC eLabeling process with Global RA Ops Labeling Lead and Global Labeling Process Steward. Lead periodic gap and risk assessments of the eLabeling process to identify trends and/or areas of concern that may affect eLabeling operations and corroborate with necessary functions to assess mitigation strategies for maintaining compliance to standards. Own NCEPs and CAPAs associated with the global eLabeling process and manage escalation tasks for NCEPs associated with global eLabeling. Collaborate with eLabeling team to facilitate global and divisional communications for process and requirements updates. eLabeling Process & Audit SME- Support internal/external audits for the Global Quality System to demonstrate compliance of BSC's eLabeling processes. Consult with project teams on complex eLabeling challenges to identify solutions and, as required, drive updates to the Quality System. Support internal/external audits at BSC sites if complex questions arise and local labeling function requests support. Engage with sites concerning internal audit findings, NCEPs, and CAPAs associated with the labeling process. Focus on education for project teams, labeling practitioners, etc. Documentation Updates Strategist - Manage the release strategy, communication delivery, and implementation roll-out for all eLabeling procedural documentation. Owner of eLabeling document suite, collaborating with eLabeling team on documentation needs. Review and assess current eLabeling documentation and provide strategies for continuous process improvements. Apply corporate and regulatory documentation requirements. General requirements: Ability to summarize and convert complex information and process flows, into clear and concise documentation that supports BSC labeling processes. Manage, organize, and communicate initiative information, project activities and status. Partner with the eLabeling Team to create storyboards and communication strategies to support the roll out of new or revised eLabeling processes. Provide training to divisional labeling staff on new processes. Manage priorities strategically and tactically t assure execution and alignment of functional and project goals. Work with the eLabeling team and other stakeholders to understand priorities, and plan resource and time allocation accordingly. Coordinate complex process changes through effective management of own activities and those that are delegated to other contributors. Manage, organize, and communicate project information and project activities for critical or multi-site initiatives. Manage project execution by executing tasks, tracking project schedules, identifying risks, and developing contingency plans. Communicate project status by preparing standard status reports, and by participating in project status update meetings. Support literature configuration lifecycle management strategies, teams, and projects; resource support alignment across various literature requirements, sub-processes, and the development of capabilities. Prepare visual presentations and present live with Labeling and/or Cross Functional Teams in multiple forums as required to provide visibility to, share, and discuss eLabeling requirements and documentation updates. Management Requirements Effectively communicate objectives and strategies to secure confidence and alignment for future organizational goals. Ability to work independently with minimal oversight and supervision. Demonstrates confidence and knowledge required to influence others, resulting in the ability to drive work to completion (not as a direct report, but as a team member and/or peer). Job Scope and Leveling Guidelines * Knowledge: A seasoned, experienced professional with wide-ranging experience and expertise in the labeling field. Applies comprehensive knowledge to resolve complex issues in creative ways. Broad knowledge of other related disciplines. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships. Is recognized as an expert in the work group. * Problem Solving: Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique and solutions may serve as precedent for future decisions. * Planning and Organization: Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones. Discretion/Latitude; Supervision Received; Decision Making: Works without appreciable direction. Works independently on highly specialized projects with long range objectives. Exercises considerable latitude in determining objectives of assignment. Selects methods and techniques to lead a project to completion. Work is reviewed from a relatively long-term perspective, for desired results. Requisition ID:576753 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if... For full info follow application link. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

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