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Regulatory Labeling Associate
Ref No.: 18-11963
Location: Jacksonville, Florida
Start Date / End Date: 09/10/2018 to 05/12/2019
Provides support to the Labeling Center of Excellence (LCoE) team by supporting labeling initiatives, including and not limited to development and review of existing and new product labeling.

Must be able to:
  • Work independently and in a team environment on routine tasks
  • Demonstrates technical competency to perform job functions
  • Demonstrates compliance with departmental operations
  • Demonstrates interest and motivation to continue learning
  • Identifies and implements improvements on work assignments
  • Completes technical tasks in a timely manner
  • Interacts effectively with peers and supervisors
  • Adapts to changing priorities

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
  • Able to assist in reviewing, analyzing, and evaluating proposed worldwide labeling including, but not limited to Instructions for Use for accuracy against established standards (60%)
  • Gathers and analyzes data related to labeling and prepares associated metric reports (20%)
  • Assists in reviewing clinical labeling for accuracy against established standards (10%)
  • Other activities and tasks to support the LCoE or Global Regulatory Affairs department, as assigned by management (10%)

QUALIFICATIONS
  • Minimum education required for competent performance:
  • High school diploma required, Bachelor's degree preferred. Fluent in English required and fluency in written Spanish (nice to have, but not required)
  • Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
  • 0 years with bachelor's degree or 3 years of prior operations, RA, QA, or R&D experience preferred. Regulatory and/or labeling experience preferred.

Flexibility to work on multiple projects, attention to detail, very good organizational, communication and interpersonal skills.

Equipment usage and abilities needed:
Familiarity/working knowledge of the following software programs (Required):
  • Microsoft Outlook
  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint

Additional preferred software program experience includes:
  • Adobe Acrobat Professional
  • Adobe InDesign