R&D Document Management Coordinator 1

Job Description

Job Summary:

• The Associate works with the Labeling team to design, test, and manage labeling for Client Surgery products.
• The associate will work with label software and product labeling documentation within Client Surgery, for both new and sustaining products.
• Activities may include, but are not limited to, project management, labeling design and development, translation service coordination, and implementation of labeling at any of the manufacturing sites.

Duties and Responsibilities:

• Develops and modifies labeling for product labels, cartons graphics, inserts, and other related material with supervision.
• Works with cross-functional teams to verify labeling compliance.
• Supports labeling team collecting or transferring labeling information between templates or software systems.
• Develops and manages labeling changes within the approved document management system.
• Designs product labeling with guidance from senior labeling team members but is able to troubleshoot such factors as product identification, aesthetic quality, printing, and production needs.
• Manages multiple concurrent deadlines and prioritizes work as needed.
• Complies with the U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company Policies, Standard Operating Procedures (SOP), working instructions, and task assignments.
• Performs other related duties and responsibilities, on occasion, as assigned.

Education and Experience:

• Bachelor’s degree in Art/Graphic Design preferred (Associates and/or experience will be considered in place of degree).
• 1+ year experience working in a regulated industry with exposure to manufacturing (e.g., medical device or pharma).
• Experience with a label software (e.g., EasyLabel, NiceLabel, BarTender, or enLabel).
• Experience designing and maintaining clinical labeling or marketing materials for a regulated industry will be considered towards design experience.
• Experience utilizing design software and graphic tools such as Adobe Illustrator, Photoshop, InDesign, Adobe Pro, and other related software.

Knowledge, Skills and Abilities:

• Should have excellent organization, problem-solving/troubleshooting skills, along with the openness to raise questions and ideas.
• Ability to communicate timely and effectively with team members and supporting services, regardless of location.
• Customer-service oriented with demonstrated ability to work on cross-functional teams with internal and external personnel.
• Basic English writing and editing skills, along with good verbal communication skills.
• Flexibility to accommodate and manage changing priorities, deadlines, and project needs.