Clinical Pack & Label Outsourcing Coordinator

Job description

The outsourcing coordinator coordinates the packaging and labeling of high quality clinical supplies through third-party contractors, from planning through release, on time and on budget.

· Be part of the technical team and discuss packaging design with Clinical Supplies Integrator & manage timelines with Supply Chain Managers.
· Ensure financial and payment responsibilities are taken care of: Obtain quotes and ensure approval of the quotes. Review invoices and provide feedback to ensure PO's are covered
· Coordinate packaging projects with packaging contractors:
· Negotiate timelines and follow up on the progress of the project to assure timely release and distribution of the clinical material to the clinical site.
· Deliver all necessary documentation and information.
· Review packaging instructions and label copy, ensure availability of randomization information, obtain and/or coordinate pre- and post-packaging approvals.
· Escalate potential missed timelines and look for possible solutions to minimize impact.
· Assist periodically in monitoring contractor performance.
· Ensure availability of all material and documentation. Supervise packaging activities and obtain release through Quality Assurance. Act as J&J interface.
· Maintain knowledge of appropriate preparation, testing, storage and dispensing of drug products and components plus knowledge of regulatory and GMP requirements.
· Maintain good working relationships and steady contact with contractor, CSI/TSM, SCM ,QA, AD, and other business. partners
· Engage on audits & audit preparedness in collaboration with vendor & QA as needed.

Other duties :
· Create process a process map between Janssen and Catalent including all supporting sop's and documentation. This “play book” will provide outsourcing coordinators with work instructions on how to work with Catalent and ensure all training is aligned plus it will include special instructions for working with Ngencodac as a tool at vendor sites. These processes will be utilized to enhance the processes that are currently being executed by other packaging and labeling outsourcing vendors.
· Close contact and communication with both internal and external partners to coordinate P&L activities and resolve planning issues, aligned with the outsourcing process

Desired profile

Qualifications :

·  University/Bachelor Degree or Equivalent Experience, Generally requires (2-5) years related experience
·  Experienced in utilizing appropriate software to effectively manage a supply chain (e.g. inventory management system)
·  To work with different software systems depending on vendor
·  Basic knowledge on GMP or good documentation practices
·  Operational and data analysis skills