Integra LifeSciences Coordinator, Labeling Project in Plainsboro, New Jersey
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
The Marketing Operations Labeling Project Coordinator is responsible for driving, tracking, and following-up on the development of medical device labeling in accordance with internal corporate and external requirements. Coordinates label artwork development, review, and approval processes to support new product launches and update existing product labeling. Collaborates with cross-functional partners and key stakeholders in Marketing, Regulatory, Quality Assurance, R&D and Global Operations to help define project requirements, artwork specifications and verify content. The Labeling Project Coordinator works with Project Leaders, Graphic Designers, Technical Writers, and Labeling Specialists to deliver labeling projects at the desired quality necessary to satisfy regulatory compliance requirements, manage process efficiency, and meet project timeline objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Support strategic product launches and ongoing maintenance of existing products by coordinating the creation, approval, and implementation of core product labeling
Work with project teams to define and consolidate label content requirements
Drive artwork approval of product labeling to ensure accuracy, consistency and compliance with internal policies and procedures and external Regulatory requirements and guidelines
Monitor and potential risk scenarios and support resolution activities to mitigate project timeline risk
Create tracking tools and dashboards to monitor all labeling change deliverables across multiple manufacturing facilities and projects
Ensure adherence to agreed project timelines for labeling deliverables
Coordinate label content translation and verification process
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education: Bachelors degree
Experience: 2-4 years of experience, ideally in medical device or pharmaceutical labeling development and management
Knowledge of medical device industry barcode trends and requirements
Strong attention to detail
Ability to collaborate well with cross-functional business partners across a large matrix organization
Strong organizational and project management skills
Aptitude for learning new software and systems
Ability to acknowledge issues or problems and work quickly to identify solutions
Knowledge of core Microsoft Office software including Word, PowerPoint, Excel and Project
Knowledge of graphic design processes and software including InDesign, Photoshop, and Illustrator a plus
Vacancy ID 2018-26739
Position Type Regular Full-Time