Senior Coordinator, Clinical Supply

Role Summary

Serves as the primary contract for project management of key Clinical Supply Chain documentation, tasks, and packaging activities in a GMP environment. Owns readiness activities for clinical supply packaging operations and the inventory management system setup required to drive packaging operations.

Responsibilities

• Ensures system set up components are available on time to support Clinical Packaging Production as needed. Owns design, creation, and approval processes for inventory management system activities
• Identify and lead opportunities for process improvements within and cross functions. Responsible for creating and maintaining processes and procedures related to group activities.
• Extract job specific information from planning system to independently create protocol-specific packaging work orders. Serves as primary representative for packaging job readiness in all packaging operations meetings.
• Provide support for pre-approval access and investigator-initiated studies.
• Act as a key interface between project management group, packaging operations, and QA, influencing when needed to ensure packaging activities are set up appropriately and efficiently
• Identifies, develops, communicates and tracks task completion dates, activities, logistics, and milestones in support of CSPMs to ensure the timely availability of investigational drug supplies.
• Serves as trainer to newer team members for all job responsibilities. Develop and maintain up-to-date Training Module for Center of Excellence. Review and update training matrix for all departmental employees as required.
• Translates stability and pre-packaging requests into an executed packaging design. Owns complete process from system set-up, to work order requests, to material transfers, as needed.

Qualifications

• Bachelor’s degree in the Life or Physical Sciences preferred. Will consider Business Administration, Math or Engineering with appropriate work experience.
• 3-5 total years of Pharmaceutical or Biotechnology industry or equivalent experience preferred.
• Must possess a thorough understanding of the overall clinical drug supply chain in a global operating enterprise.
• Must possess knowledge of regulations and standard affecting pharmaceutical products (i.e., CFR210/211, cGMP, etc.).
• Must have excellent problem solving and logical reasoning skills.
• Proactive approach to problem solving, thinking outside of the box, and ability to identify creative solutions to unique problems.
• Must be prepared to continually recognize the needs of Materials Management customers, prioritize as necessary, and trouble shoot abnormal or challenging situations.
• Proficient with standard computer software. Must be able to effectively manage multiple projects at one time.
• Strong Project Management skills.
• Strong communication skills (both written and oral). Ability to work independently or with a group.

Skills

• Problem solving and logical reasoning skills
• Proactive, creative problem solving
• Strong project management
• Strong written and oral communication
• Ability to work independently or in a team
• Proficiency with standard computer software
• Ability to manage multiple projects simultaneously