Purpose:

The Clinical Label Associate role is primarily responsible for critical review and approval of all clinical label

templates created by the labeling team for single panel and booklet labels. This responsibility includes

insuring compliance with all Regulatory requirements for each country included in the label.

This individual is the primary owner of the phrase library including approval of new phrases and will have

sole responsibility for phrase library change management. They will also assist the label manager in

maintenance and change management of country specific regulatory requirements for clinical labels.

Responsibilities:

• Perform detailed review and approval of global clinical templates for both single panel and booklet labels, ensuring global country regulatory requirements are followed.
• Perform detailed review and approval of label designs for both single panel and booklet labels in a specialized, validated label design program ensuring proper format and adherence to country specific regulatory requirements. These designs must be GMP compliant and compliant with appropriate country regulations for clinical studies around the world (US, EU, JAPAC, etc.).
• Place booklet label orders with third party manufacturers and perform review and approval of Specifications for booklet label proofs.
• Perform detailed review and approval of colleagues’ label designs ensuring content is compliant with all regulatory requirements.
• Review and assess regulatory requirements for global studies when a resupply of a booklet is required.
• Perform label inventory review on a regular schedule and assess impacted inventory, creating destruction requests for expired inventory as appropriate.
• Approve new phrases added to the controlled phrase library for use in creating clinical label templates and execute Change Management of the phrase library including impact assessments and implementation of changes.
• Execute annual review of the phrase library.
• Create new and update existing global Regulatory requirement templates.
• Support goals and projects within the labeling team, and represent the labeling team on cross-functional department initiatives.

Basic:

• Bachelor’s degree preferred.
• 3-5 years of experience with clinical trial design and packaging preferred.
• Key Critical skills:
  • Proven ability to work independently, diligent attention to detail, and maintain a highlevel of accuracy when completing all activities.
  • Leadership, analytical, project management, andorganizational skills.
  • Good verbal and written communication skills.
  • Must be proficient at multi-tasking,responsible for timelines, adapt to changing priorities, and provide status updates on an ongoing basis.
  • Computer proficient.