R&D Document Management Coordinator -1

Company: Katalyst Healthcares & Life Sciences
Location: Vernon Hills
Posted on: May 24, 2023

Job Description:

Job Description

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.
• Design 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.
• Manage 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. Requirement:
  • Bachelor's degree in Art/Graphic Design preferred (Associates and/or experience will be considered in place of degree).
  • 1+ year experience working in 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 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.
  • Should have excellent organization, problem solving / troubleshooting skills, along with the openness to raise questions and ideas.
  • bility to communicate timely and effectively with team members and supporting services, regardless of location.
  • Customer-service orientated with demonstrated ability to work on cross-functional teams with internal and external personnel.
  • Basic English writing, editing skills along with good verbal communication skills.
  • Flexibility to accommodate and manage changing priorities, deadlines, and project needs.

Keywords: Katalyst Healthcares & Life Sciences, Arlington Heights , R&D Document Management Coordinator -1, Executive , Vernon Hills, Illinois