When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are seeking a detail-oriented Regulatory Affairs Associate to join our team as an Artwork Coordinator. In this role, you will be responsible for coordinating, tracking, and managing all artwork changes within Veeva RIMS, ensuring seamless progression from initial request through to final approval and implementation.

This is a client facing role and can be based in various European locations (home or office based).

Key Responsibilities

Artwork Management & Coordination

• 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

Quality Control & Documentation

• 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

Stakeholder Communication & Collaboration

• 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

Skills & Expertise required for the role:

• 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)