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Labeling Project Specialist II Job

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Date: Nov 18, 2020

Location: Minnetonka, MN, US, 55343

Company: Boston Scientific

Additional Locations: Marlborough, MA

 

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 primary mission for the Labeling Project Specialist (LPS) is to plan, manage, and direct the creation/revision of product literature and labeling. The LPS works closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures. They develop schedules and ensure labeling deliverables are executed to them while maintaining a high standard of quality. The LPS is the resident expert and primary point of contact for all things related to product literature and labeling.  
 
Your responsibilities 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. 

 

What we’re looking for: 
 Basic Qualifications 

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

 Preferred Qualifications

  • 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 

 

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.

 

 


Nearest Major Market: Minneapolis

Job Segment: Medical, Electrical, Medical Technology, Document Control, Medical Device, Healthcare, Engineering, Administrative