Clinical Supplies Lead

Job Description

· Scheduling and oversight of labeling associates

· Work side-by-side with labeling associates to execute hands-on labeling and secondary packaging operations

· Perform pre-execution review of assembly records for clarity, feasibility, completeness and to ensure availability of needed materials

· Schedule packaging and labeling operations within the Skillman labeling suite

· Train packaging and labeling assistants on specifications and requirements of each project as appropriate

· Perform in-process checks of packaging and labeling activities to ensure execution of operation is as intended and meets both company and regulatory requirements

· Ensure execution of packaging and labeling activities occur according to written instructions and timelines

· Effectively interface with Clinical Supply managers to plan for and schedule clinical supply projects to meet business requirements

· Ensure compliance with applicable SOPs and EHS requirements by individuals working in the Skillman packaging and labeling suite

Critical Competencies

· Basic knowledge of clinical trial process

· Knowledge of cGMP and regulatory guidelines

· Attention to detail

· Quality focus

· Customer focus

· Ability to respond well to rapidly changing priorities, tight timelines, and evolving requirements

· Superior organization and time management skills

· Ability and willingness to perform repetitive tasks expediently and diligently

· Good communication and interpersonal skills

· Demonstrated ability to perform as a team player and willingness to provide support where and when needed