Boston Scientific Labeling Project Specialist II 

United States, Minnesota, Arden Hills 

961549242

Your Responsibilities will Include:

• Responsible for coordination of all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, etc.
• Manage and coordinate creation/revision of deliverables from project initiation through completion.
• Assess the scope of each project and work with team members and project management to create labeling plans and secure necessary resources.
• 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.
• 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.

Required Qualifications:

• Associate’s Degree
• 4+ years’ work experience in regulated industry.
• Medical Device Experience
• 2+ years Labeling experience

Preferred Qualification:

• Direct labeling or technical writing experience desired.
• Bachelor’s degree
• Medical Electrical Equipment/ Capital Equipment experience
• Adobe Suite Creative Suite experience strongly preferred.
• MS Office and MS Project experience strongly preferred.
• Project Management

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.