Global Labeling Project Manager I

Additional Locations:  N/A

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.

Location: Arden Hills, MN

Work Mode: Hybrid, 3 days required onsite. No Remote Employees for this role.

About the role:

Manage the development and implementation of Global Labeling processes to increase efficiency and process improvements. This role will work with cross divisional labeling leadership and partnering with other Global Labeling employees/groups to ensure successful outcomes. 

Your responsibilities will include:

• Ability to summarize and convert complex information and process flows, into clear and concise documentation that supports BSC labeling processes.
• Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
• Lead, manage, organize, and communicate project information, project activities and status on a routine basis.
  • Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.  
• Resolves project issues by working with team members, project customers, and others as appropriate.
  • Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
• 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.
• Follow up with sites (as necessary) to ensure IRR tasks are completed in a timely manner.
• Engage Learning and Development to ensure global training curriculums have the appropriate documents and task-based questions.
• Review data from reports and other sources to identify and implement process improvements for labeling documents that better support global labeling function.
• Consults with internal project groups by sharing project management knowledge and assisting or mentoring more junior project leaders in project management processes and techniques.
• Manage priorities strategically and tactically to assure execution and alignment of functional and project goals. Work with labeling council and other stakeholders to understand priorities, and plan resource and time allocation accordingly.
• Apply corporate and regulatory documentation requirements.
• Provide practical guidance to product teams through challenges they encounter in labeling processes and systems.
• Engage with acquisition integration teams to develop integration strategies for labeling.
• Support internal/external audits for the Global Quality System to demonstrate compliance of BSC's labeling processes.
• Participate in the review of new regulations/standards and the implementation of new requirements into the BSC labeling process.
• Perform periodic compliance assessments of the labeling process to identify trends or areas of concern.
• Own NCEPs and CAPAs associated with the global labeling process and manage escalation tasks for NCEPs associated with global labeling.
• Support literature configuration lifecycle management strategies, teams, and projects; resource support alignment across various literature requirements, sub-processes, and the development of capabilities
• Support the expanded use of elabeling processes and requirements, partnering with the elabeling Process SME

Required qualifications:

• Bachelor’s degree.
• 5+ years of work experience within Medical Device Labeling specialty.
• Requires specialized and comprehensive technical and/or functional knowledge in Labeling function.   
• Minor travel depending on home BSC site may be required.  Typically, one trip per year. 

Preferred qualifications and competencies:

• Ability to lead projects with manageable risks and resource requirements, often broader, cross-functional projects
• Ability to solve complex and diverse problems, takes a new perspective on existing solutions and exercises judgment based on the analysis of multiple sources of information using specialized knowledge of various alternatives and their impact on the business

• Knowledge of business and industry best practices and how Labeling function integrates with others to achieve objectives to drive results.
• Proven ability to lead discussions and makes presentations in cross-functional meetings, effectively presenting information to explain recommendations and implications

Requisition ID: 590644

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 you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!