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Boston Scientific · 2 days ago

Labeling Project Specialist II

Marlborough, MA

Full-time

Hybrid

Entry, Mid Level

$63K/yr - $119K/yr

2+ years exp

Boston Scientific is a leader in medical science dedicated to solving significant health challenges. The Labeling Project Specialist II is responsible for planning, managing, and executing labeling projects to ensure compliance with regulatory requirements and high-quality standards for product labels and Instructions for Use (IFUs).

Health CareMedicalMedical Device

No H1B

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

Qualification

Product labeling experienceLabeling software proficiencyAdobe Creative SuiteDocument control systemsMS Office proficiencyCritical thinkingProblem-solvingOrganizational skillsInterpersonal skillsCommunication skills

Required

Minimum 2 years of experience in product labeling with knowledge of labeling processes including up-front label content requirements, translation management, document review, regulatory agency practices and requirements

Experience with Adobe Creative Suite, labeling software, and/or document control systems

Proficient with MS Office applications (i.e. Teams, Word, PowerPoint, Project etc.)

Ability to travel up to 5%