Boston Scientific Principal Acquisition Labeling Lead 

United States, Minnesota, Arden Hills 

212503502

About the Role:

The Acquisition Labeling Lead plays a critical role in managing labeling deliverables for global acquisition efforts. This individual oversees yearly projects, working closely with assigned practitioners and Project Management to develop effective strategies. Their responsibilities include ensuring that labeling content adheres to all applicable procedures, maintaining high-quality standards, and managing schedules for labeling deliverables. As the resident expert, they serve as the primary point of contact for all matters related to acquisition product literature and labeling.

Your Responsibilities will Include:
Leadership Responsibilities:

• Works with executive management, management, and team members to set project strategy, priorities, and scope
• Works closely with project and functional managers to develop pre and post integration plan and strategy
• Works closely with Acquisition Packaging & Labeling Managers during yearly AOP resource planning
• Be the first point of contact to address issues with program labeling, labeling content, and labeling processes
• Provide work direction, mentor, and train less experienced labeling practitioners (with possibility of direct reports if interested, but not required)
• Initiate, coordinate, and lead cross-functional conversations, as necessary to communicate project status, issues, and resolutions to stakeholders
• Help manage labeling deliverables by ensuring practitioners understand timeline expectations
• Monitor and lead project progress and identify and mitigate risks

Practitioner Responsibilities:

• Responsible for coordination of all labeling deliverables (will vary by acquisition), including labels, IFUs/DFUs, and carton and pouch artwork, etc.
• Manage and coordinate creation/revision of deliverables from project initiation through completion
• Advocate and gain approval to use Global Labeling Systems prior to LMMB
• Assess the scope of each project and work with team members and project management to create labeling plans and secure necessary resources
• Point of contact for all project labeling issues and available for to support critical project launch milestones
• Develop deliverable schedules and establish milestones for tracking progress. Ensure on-time completion of deliverables, and communicate project status, challenges, and successes on a regular basis to project and functional management
• Understand and coordinate/monitor completion of key dependencies from other functions
• Monitor and, when necessary, work with functional and project management to address issues that could negatively impact schedule or quality
• Understanding, asking questions, digging for information to help communication to leadership, stakeholders, reviewers, etc the requirements, issues, resolutions, explanations, to allow the team to focus on the deliverables
• Lead cross functional teams through content development for labeling deliverables by managing the drafts, collecting input and source data, making changes, tracking revisions, and keeping teams on schedule
• Foster and improve content consistency across labeling
• Facilitate team reviews of labeling deliverables to ensure content is accurate, complete, fully compliant to relevant regulations and requirements, and meets the needs of the customer
• Coordinate desktop publishing and labeling artwork generation
• Coordinate implementation/release activities of labeling deliverables
• Manage content changes (and mitigate their impact on schedule and consistency) by pushing teams to focus on accuracy and completeness
• Implement product labeling via Boston Scientific’s Document Control System
• Leverage expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors
• Identify and implement opportunities for continuous improvement and innovation
• Enforce the Boston Scientific Quality Standards

Required Qualifications:

• University degree or the equivalent combination of education and experience
• 5+ years work experience in regulated industry
• 5+ years Labeling experience
• Medical Electrical Equipment/Capital Equipment experience
• Medical Device experience
• Adobe Creative Suite experience

Preferred Qualifications:

• Direct labeling or technical writing experience desired
• Bachelor’s degree
• Adobe Suite Creative Suite experience strongly preferred
• MS Office and MS Project experience strongly preferred
• Technical or non-technical writing experience

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.