Job Title: Senior CTS Packaging & Labeling Specialist
Assignment Length: 6 months (initial)
Shift: Standard Business Hours
Location: Hybrid (Up to 50% onsite) — King of Prussia, PA (strongly preferred) or Holly Springs, NC (considered)

Travel Expectation: Limited travel (domestic and international) may be required.

About the Role

We are seeking a detail-oriented and experienced Senior CTS Packaging & Labeling Specialist to join our clinical trial supply (CTS) team. This role focuses on the operational execution of packaging and labeling clinical trial materials, supporting global study teams with expertise and guidance.

Key Responsibilities

• Apply for material numbers and maintain master data for clinical trial packaging materials.
• Consult global CTS study teams on packaging design development as the packaging expert.
• Create and maintain packaging plans based on clinical demand and timelines.
• Manage inventory and ordering of packaging components, ensuring alignment with delivery schedules.
• Generate packaging orders in SAP and coordinate with global departments through to order release.
• Prepare and process kit lists for unique identification of trial material containers.
• Coordinate global sample provision for release testing post-packaging.
• Ensure retention samples are collected, stored, or destroyed per regulatory standards.
• Initiate and manage packaging reworks and relabeling (e.g., expiry date updates).
• Develop and maintain packaging status reports and study-specific label text templates.
• Provide translated, regulatory-compliant label texts for submissions to participating countries’ authorities.
• Coordinate label printing with internal/external teams and service providers.
• Collaborate with global teams on label design and maintain client specific label translation databases.
• Support additional departments (e.g., Global Commercial Development, Medical Affairs) in packaging and shipping clinical trial materials.
• Develop, review, and revise SOPs, forms, and templates related to packaging and labeling.
• Process Global Change Control requests and participate in audits/inspections related to trial materials.
• Lead or participate in meetings with global CTS study teams and external providers to define packaging and labeling strategies.

Minimum Qualifications

• Bachelors Degree (Life Sciences preferred)
• 2+ years of experience in clinical research, clinical supply management, or global R&D project management in pharmaceuticals (3+ preferred).
• Solid knowledge of ICH-GCP regulations and clinical study conduct.
• Understanding of cGMP and GxP standards (GxP knowledge prioritized).
• Experience with SAP preferred.
• Basic knowledge of clinical study processes expected.
• Flexibility in working hours to accommodate global collaboration (some early hours required).
• Strong operational and execution skills; this is not a strategy or leadership role but a highly responsible hands-on position focused on packaging and labeling.
• Knowledge of clinical study regulatory environment strongly preferred.