Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
About the Role
The Project Management Lead, working with cross-functional team members from R&D, Design Assurance, Packaging, Labeling, Regulatory, Operations and IT, will simultaneously handle multiple projects and initiatives of various sizes. This includes leading the development and execution of an eLabeling strategy and supporting related work stream activities for eLabeling of medical device products at Boston Scientific. The Project Management Lead is a global position which will support all BSC business units.
The location for this role is open and flexible. The person in the role can sit remotely and does not need to be based in Minnesota or Massachusetts
* Develops, establishes and owns the business process for effective patient and professional use eLabeling. * Manages BSC's eLabeling documentation infrastructure (procedures, work instructions, supporting documents, and websites). * Implements eLabeling specific training to cross-functional teams to raise awareness of eLabeling processes. * Partners with IT and other functions to define user requirements for the eLabeling website while enhancing the user experience. * Provides strategic communication through stakeholder engagement. * Assesses new and changing regulations, standards, and requirements for impact to existing eLabeling processes. * Supports updates of International processes when new allowances for eLabeling are made. * Facilitates introduction of eLabeling to new countries. * Defines projects for implementing eLabeling changes and provides input to project planning for product-level execution of eLabeling updates. * Works cross-functionally to appropriately address external and internal change drivers, and their impact to existing systems, infrastructure, projects, and products. * Serves as an eLabeling regulations and requirements expert, providing insight to cross-functional initiatives and guidance to product-level teams. * Serves as a peer on BSC Communities of Practice related to labeling. * Teams with the Labeling Quality Systems Steward and Labeling SMEs. * 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. * Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans. * Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings. * Resolves project issues by working with team members, project customers, and others as appropriate. * Participates in external labeling standards development organizations, conferences and seminars to keep current with industry knowledge and implementing a professional development plan with focus on labeling and project management. * Identify, communicate, and manage moderate levels of business and compliance risk. * Make occasional presentations to upper management
* Bachelor's degree with 4+ years of relevant project leadership experience in Regulatory, Labeling, or other related areas leading projects or as a team member leading significant segments of projects. * Strong familiarity with medical device labeling regulations and standards. * Demonstrated project management experience, ideally related to generating high-level plans, communications, and schedules on larger projects/initiatives. * Demonstrated ability to effectively organize and communicate complex information. * Strong organization and execution skills will be required, as well as a demonstrated ability to confidently handle the top responsibility for project/initiative oversight. * Exceptional oral and written communication skills, comfortable engaging with any size and level of audience. * Demonstrated ability to manage complex change cycles impacting multiple functions and processes, including a proven ability to effectively prioritize interconnected and/or competing tasks. * Ability to act as a change agent, supporting the identification, integration, and implementation of new requirements and improvements to existing systems and processes. * Ability to work cross-functionally with peer and customer groups, and to develop positive partnerships. * Ability to influence broader organization in the adoption of new requirements and improvements, including comfort in presenting to and influencing senior-level audiences. * Exceptional attention to detail, and the ability to connect-the-dots across a complicated network of external and internal requirements, processes, and systems. * Strong facilitation skills, and ability to drive others to produce results absent a direct reporting relationship. * Ability to be resourceful and self-sufficient, driving toward objectives with limited direction and/or no pre-defined conclusions. * Strong MS Office proficiency.
* Experience with interpreting Standards, Regulations and country requirements pertaining to Labeling requirements. Strong knowledge and understanding of BSCs internal labeling processes; including localization. * Broad product knowledge across multiple franchises is preferred over individual product expertise. * Strong analytical and problem-solving skills, including the ability to identify and implement novel solutions to meet business needs.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer - Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 447916
About Boston Scientific
Boston Scientific is a developer, manufacturer, and marketer of medical devices.