Labeling Project Specialist II

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.                

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 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

Requisition ID: 590630

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance 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.

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.