Parexel

Regulatory Affairs Associate – Artwork Coordinator

Parexel

full-time

Posted on:

Location Type: Remote

Location: Croatia

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About the role

  • Coordinate, track, and manage all artwork changes within Veeva RIMS from receipt of new artwork change requests until approval
  • Create and manage Artwork Projects in Veeva RIMS for customer artwork changes
  • Review artwork in accordance with client procedures
  • Manage changes to the lifecycle of artwork components in Veeva RIMS
  • Create Artwork Projects and AW Briefs in Veeva RIMS for technical changes without regulatory impact
  • Create new SKUs in Veeva RIMS
  • Update, maintain, and QC Artwork Project details, ensuring accuracy of: AW Implementation dates, Related object fields, Document metadata fields (as applicable)
  • Request Print Proofs and run comparator reports when needed
  • Manage new component item codes
  • Liaise with client stakeholders to progress artwork changes as applicable
  • Communicate implementation dates to manufacturing sites
  • Escalate issues as required to ensure artwork development deadlines are met
  • Provide information to Quality Assurance (QA) EN and Partners regarding approval and implementation dates of new artwork
  • Attend project-related meetings

Requirements

  • University degree in a life science discipline
  • Previous experience with managing artwork updates as part of Regulatory Affairs team
  • Strong coordination skills with team members and client stakeholders
  • Excellent planning skills with ability to follow up on timelines and meet KPIs
  • Strong communication skills and proven ability to work effectively within a team
  • Veeva RIMS knowledge (required)
  • Fluent English (written and verbal).
Benefits
  • Flexible work arrangements
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
artwork managementproject managementquality controlregulatory compliancelifecycle managementSKU creationdocument metadata managementcomparator reports
Soft Skills
coordinationplanningcommunicationteamworkstakeholder management
Certifications
university degree in life science