Sr. Labeling Business Partner

Irvine, CA

Post Date: 06/08/2018 Job ID: JN -062018-25448 Industry: Manufacturing & Engineering
We are currently seeking a Sr. Labeling Business Partner to be the subject matter expert (SME) that collaborates with Business Unit customers and cross-functional stakeholders (Regulatory, Packaging, Quality, Marketing, NPD etc.) to deliver successful labeling changes and requested new labeling. The Global Business Labeling Specialist will be responsible for consolidating labeling requirements and scope, and timelines for labeling changes required for new product project teams and for other sustaining business needs.

Global Business Unit Labeling Specialist Responsibilities:
  • Drive labeling activities to initiate and deliver to Operations labeling content changes through updates to product labels, instructions for use (IFU) and other forms of regulated labeling materials, in compliance with global and regional standards and regulations.
  • Responsible for engaging cross-functional teams to resolve obstacles, meet key labeling objectives, and collaborate on continuous improvement initiatives.
  • Support development of solutions for labeling initiatives
Sr. Labeling Business Partner Key Requirements:
  • Bachelors Degree (Science related preferred, but not required)
  • Minimum of 5 years labeling experience in either Medical Device Industry or Pharmaceutical
  • Minimum of 2 years experience developing labeling for medical devices for FDA and global markets and developing/improving documentation (i.E. SOPs) in an FDA regulated industry
  • Project Management Professional (PMP) Certificate preferred
  • Strong relationship management and communication skills, both oral and written, in order to influence others and operate effectively with ambiguous situations
Compensation & Benefits:
  • Salary between $90k-105k annually
  • Comprehensive Benefits package
  • Possible Relocation benefits for the ideal candidate

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