Labeling Project Specialist II at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

115900.0

Posted On

07 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Labeling Procedures, Project Management, Cross-Functional Collaboration, Desktop Publishing, Regulatory Compliance, Translation Management, Document Control Systems, Adobe Creative Suite, MS Office, Critical Thinking, Problem Solving, Organizational Skills, Interpersonal Skills, Communication Skills, Results-Oriented, Independent Work

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): US-MA-Marlborough 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 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. Your responsibilities will include: 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 Required qualifications: 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% Preferred qualifications 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 Requisition ID: 617494 Minimum Salary: $ 61000 Maximum Salary: $ 115900 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. 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 identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. 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. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Responsibilities

The Labeling Project Specialist coordinates timelines and deliverables for product labeling projects, ensuring compliance with regulatory requirements. This role also leads cross-functional teams in content development and manages the creation of labeling artwork.