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Specialist II, Labeling Project Specialist Job

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Date: Mar 7, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations:

 

 

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 Labeling Project Specialist II is the primary point of contact for all things labeling (DFUs, labels, artwork, source reference verification, etc.). Individuals in this role are responsible for planning, managing, and executing creation of new, or updates to existing, BSC and external supplier’s product DFUs and labeling. Labeling Coordinators ensure that labeling is fully compliant to all relevant requirements and that deliverables are completed on schedule while maintaining the highest quality standard.

 

Your responsibilties include:

  • Responsible for the following deliverables which will vary by project: DFU, eDFU, patient guide, implant card, labels, carton and pouch artwork, label stock artwork, internal labeling system template design, and all other labeling related deliverables.
  • Manage and coordinate creation/revision of deliverables from project initiation through completion.
  • Assess the scope of assigned labeling projects and work with project and functional management to create labeling strategy.
  • Develop deliverable schedules (Gantt if required) and establish milestones for tracking progress.
  • Ensure on-time completion of deliverables, including externally sourced, 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, such as mechanical drawings, schematics, testing reports, etc.
  • Monitor and, when necessary, escalate issues that could negatively impact schedule or quality.
  • Lead cross functional teams through DFU content development by managing draft DFUs, collecting input, verifying supporting documentation, making changes, tracking revisions, and keeping the team on schedule.
  • Foster and improve content consistency across DFUs and labels.
  • Facilitate team review of DFUs to ensure content is accurate, complete, fully compliant to relevant regulations and requirements, and meets the needs of the customer.
  • Collect labeling source data and populate labeling system templates (LSTs). Facilitate thorough team review of LSTs and final output labels.
  • Coordinate DFU desktop publishing, labeling artwork generation, and manage the controlled change process for these deliverables.
  • Manage DFU and label content changes, and mitigate their impact on schedule and consistency, by pushing teams to focus on accuracy and completeness early in the process.
  • Leverage expertise with labeling procedures, requirements, and quality systems to ensure all deliverables are fully compliant and free of errors.
  • Be an active participant at regular project team meetings and be proactive when speaking about labeling deliverables.

Additional Responsibilities and Expectations

  • Passion for understanding what Boston Scientific products do and how they improve the quality of patient care.
  • Provide support, guidance, and expertise in the labeling realm to project teams.
  • Develop best practices to leverage across projects and with other labeling coordinators.
  • Be constantly on the lookout for opportunities and ways to improve process and procedures

 

What we're looking for in you:

Basic Qualifications

  • Exceptional communication, facilitation, interpersonal, and relationship-building skills.
  • Extremely detail-oriented and organized.
  • Ability to clearly communicate complex information across multiple functions
  • Facilitate buy-in from team members and negotiate disagreements productively.
  • Confidence to disagree in a professional manner and humility to back down when appropriate.
  • Excellent computer skills including Adobe Creative Suite, Microsoft Office, labeling software, and document control systems,
  • Strong knowledge of labeling processes and complexities including up-front label content requirements, translation management, document review, regulatory agency practices and requirements, medical device manufacturing operations and distribution, and expertise when liaising with external vendors.
  • Skillful in English language, grammar, and writing.

 

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

 

Requisition ID: 443147

 


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