Location: West Point, PA 19486 - Hybrid role: 4 days onsite/1 day remote.
Duration: 12+ months (Possibility of extension)
Job Summary
Responsible for independently coordinating all activities associated with timely packaging, packaging, and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies.
This individual is responsible for execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress, and review of documentation and procedures.
Core Responsibilities
Read comprehend and translate clinical trial protocols /packaging specifications into clinical label generation software.
Design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems. Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
Coordination of Translation Requests
Generation of Clinical Label Proofs with CLPG
Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, revise translations, update regulatory requirements, etc.
Maintain Label Translations library.
Interpret clinical study design and Clinical Supply Strategy (CSS)
Design and verify label models.
Seniority level
Associate
Employment type
Contract
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
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