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Regulatory Affairs Senior Associate (JP8306)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Regulatory Affairs Senior Associate (JP8306)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 9 months with likely extensions
Job posting date: 3.8.21
Note: Remote until COVID restrictions are lifted for local candidates, fully remote for non-local candidates.
 
3 Key Consulting is hiring a Project Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • Pharm/biotech experience required.
  • Administrative projects as backup support of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (Veeva RIM) archiving and other process documentation authoring support).
  • Create and maintain product regulatory documents and appropriately archive all regulatory documents and agency communications per process.
  • Coordinate QC of regulatory documentation for FDA submission (e.g. Request for Advisory Comments and other FDA communications).
  • Generate Digital Asset Management (DAM) reports for vendor management program.
  • Manage and host formal WebEx meetings with meeting minutes.
  • Creation of Infographics, slides, technical editing of process documents, and proofreading.
  • Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents.
  • Experience in labeling and Regulatory document management.
  • Experience in promotional review and approval process.
  • Experience in Tableau.
  • Remote position with flexible work hours to accommodate EST employees project needs.

    Basic Qualifications: Bachelor’s degree and 1-5 YOE.
 

Top Must have Skill Sets:
  • Intermediate to advanced MS Office (including pivot tables and vlookup), required.
  • Veeva vault preferred.
  • Technical editing and infographics creation
  • Digital asset management
  • Tableau experience preferred.
 
Day-To-Day Responsibilities:
Abbreviated Reviews, system updates for label changes, archiving and process documentation authoring support, Tableau reporting support.
 
Employee Value Proposition:
The person in this role will gain experience using Veeva Vault and work with operational change management. This team is globalizing their operations.
 
Red Flags:
  • Inability to work in a flexible changing environment.
  • Must be able to handle high volume of review workloads with high degree of attention to detail for reviews of promotional materials.
  • Must be able to work in MC Office advanced level.
 
Interview Process:

Hiring manager vet resumes, phone screen and 2-3 staff video panel interview of up to 4 candidates
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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