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Regulatory Compliance Lead

|  Posted On: Feb 21, 2025

Irvine, CA 92618

10 Months, Contract

Job Summary

Job Title:  
Regulatory Compliance Lead

Posted Date:  
Feb 21, 2025

Duration:  
10 Months, Contract

Shift(s):  

08:00 AM - 04:00 PM


Pay Rate: 
46.31 US /Hourly

Description

Fully Remote

Job Description:

  • Operates as primary content approval contact for Global Sales Education/ Professional Education/ US Marketing.
  • Prepares documents for VEEVA submissions; annotating and cross checking references, tagging/linking/loading all related documents into the system.
  • Serve as the liaison between the reviewers and content developers/SMEs to reach editorial solutions
  • Immersion in relevant project claims matrices and references to become a Subject Matter Expert (SME) to proficiently and proactively navigate reviewer comments and make content recommendations that remedy compliance issues, if and when possible
  • Ensures that all submissions accurately and consistently capture MLR comments and follow submissions through to approval.
  • Create an internal tracking process that captures the current status of all projects routing for compliance review.
  • Troubleshoots and guides submission workflow in challenging situations, supporting submission approval.
  • Meets with reviewers to develop relationships, build rapport, and influence without authority.
  • Develops best practices for content submission within Global Sales Education/ Professional Education/ US Marketing.

Top Three Skills:

  • Veeva, Medical, legal, and regulatory (MLR) experience, regulatory process and deliverables, project management
  • 3-5 years exp

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