Labeling Project Specialist II
About The Position
The Labeling Project Specialist plays a crucial role in ensuring product labels and Instructions for Use (IFUs) are accurate and compliant with all relevant regulatory requirements. Under general supervision, this role serves as the primary point of contact responsible for planning, managing, and executing labeling projects to ensure deliverables are completed on schedule, while maintaining the highest quality standards for new and existing BSC and external supplier products. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.
Requirements
- Associate’s degree with a minimum of 2 years of experience in product labeling
- Proficient with MS Office applications (i.e. Teams, Word, PowerPoint, Project etc.)
- Ability to travel up to 5%
Nice To Haves
- Bachelor’s Degree
- Experience working in medical device, pharmaceutical or similar industry
- Knowledge of labeling processes and complexities including up-front label content requirements, translation management, document review, regulatory agency practices and requirements.
- Experience with Adobe Creative Suite, labeling software, and document control systems.
- Ability to work independently to meet project timelines
- Results-oriented with strong critical-thinking and problem-solving skills
- Strong organizational skills with ability to manage multiple projects and prioritize competing tasks
- Strong interpersonal and communication skills; ability to collaborate effectively with individuals at all levels
Responsibilities
- Coordinating timelines and deliverables for product labeling projects (i.e labels, IFUs, carton and pouch artwork, source reference verification, etc.) and establish milestones; communicate project status, challenges, and successes to project leads and functional management
- Leveraging knowledge of labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors
- Leading and supporting cross-functional teams through content development for labeling deliverables; implement and track revisions, manage drafts and collect input and source data
- Coordinating desktop publishing and labeling artwork creation; generate and review labeling specifications, peer reviews, and other documentation
- Coordinating with translation vendors to complete translations for labeling components
- Implementing product labeling via Boston Scientific’s document control system; perform change notice activities for the review, approval and release of labeling components and documentation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
5,001-10,000 employees
