Labeling Project Coordinator - II in Santa Monica, CA at Integrated Resources, Inc

Date Posted: 9/6/2020

Job Snapshot

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Job Description

Job Title: Labeling Project Coordinator - II  
Location: Santa Monica, CA 90404 
Duration: 18 Months 
Specific Job Requirements: 
  • Responsible for processing clinical labeling documents and completing activities associated with multiple clinical development programs. 
  • These include but are not limited to label generation and approval per regulatory guidelines. 
  • Interacts with client internal cross-functional teams to provide input into labeling options. 
  • Engages the clinical labeling group to meet company goals including department improvement projects. 
  • Works closely with ancillary groups to process and approve GMP documents 
  • Authors and reviews documents to ensure GMP compliance. 
  • Responsible for change control task closures and preliminary assessments. 
  • May participate in other Clinical Supply chain roles. 
  • Excellent verbal, written, and social communication skills are required. 
  • Strong computer and organizational skills required. 
  • Project and document management experience a plus. 
  • Experience with Change Control is beneficial. 
  • Able to anticipate client obstacles and difficulties and act upon this in order to meet goals. 
  • Ability to write clear, concise and error-free documents. 
  • Able to exercise discernment within defined procedures and policies in order to resolve and take appropriate action. 
  • Possess a knowledge of the GDP, cGMP, FDA standards as well as regulatory mentorship documents such as Annex 13. 
  • Prior experience with clinical labeling, including the technical aspects of label design, is preferred 
  • Requires a Bachelor's degree and a minimum 2 years of relevant industry experience preferably in clinical labeling or regulatory roles 
  • Please note this is more of a project management role rather than a labeling experience.