Lead, Project Management – Labeling at Boston Scientific

Remote
Boston Scientific

Lead, Project Management (Labeling) Job

  • Location: Maple Grove, MN, US, 55311
  • Additional Locations: Marlborough, MA or Any remote location with USA

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 eLabeling website day to day activities and involvement in longer term website development and execution. This position will also be partnering with the Labeling SME role and supporting related work stream activities for internal labeling process, WI and other documentation. The Project Management Lead is a global position which will support all BSC business units and geographies.

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

Key Responsibilities

  • Primary contact for assessment and disposition of triage/support tickets for the Global eLabeling website.
  • Perform all site maintenance and administrative functions for the electronic labeling website, including maintaining adequate documentation.
  • Cross-functionally suggest, assess, investigate, and prioritize backlog of website tickets to provide strategic recommendations on prioritization.
  • Closely interface with development/IT Teams on a regular basis to support ongoing and improvement activities.
  • Partner with the Labeling Quality Systems Steward, Labeling SMEs and eLabeling SME.
  • Respond to requests for data analysis from the website, including for audits and NCEP support.
  • Act as the website SME on strategy discussions about electronic labeling and data governance as a whole.
  • As needed, provide eLabeling website system training and onboarding to employees.
  • Support the business process for effective patient and professional use eLabeling.
  • Assess new and changing regulations, standards, and requirements for impact to existing eLabeling processes.
  • Work cross-functionally to appropriately address external and internal change drivers, and their impact to existing systems, infrastructure, projects, and products.
  • Support BSC labeling Communities of Practice.
  • Estimate 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.
  • Direct project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
  • Communicate project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
  • Resolve project issues by working with team members, project customers, and others as appropriate.
  • Participate 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 and councils (Packaging, Labeling, etc.).
  • Assist with documentation updates, routing docs in WC and ownership of labeling WI’s.
  • Provide labeling expertise on global labeling projects.
  • Help co-ordinate and drive document updates and process changes with GLS and GLSg groups.
  • NCEP/CAPA ownership for Corp Labeling related issues.

Basic Qualifications:

  • Bachelor’s degree with 4+ years of relevant project leadership experience in Regulatory, Labeling, Engineering, IT, 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.
  • Desire to grow in their position and develop as successors to either the eLabeling or Labeling SME positions.
  • Strong MS Office proficiency and experience learning new technical systems.

Preferred Qualifications:

  • Experience with interpreting Standards, Regulations and country requirements pertaining to Labeling requirements. Strong knowledge and understanding of BSCs internal labeling processes; including localization and eLabeling.
  • 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.

About us

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

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID: 474025

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