Function: This position is responsible for the day-to-day management of distribution activities related to specific projects and assuring overall cGMP compliance with all procedures affiliated with processing shipping documents and the distribution of clinical supplies.
Reporting to: Vice President of Operation
Duties and responsibilities: Initiate and/or participate in preliminary discussions with assigned client proposals regarding a plan for the distribution of study materials before shipping begins.
Act as liaison between the client and internal departments for the requisition of required documentation (i.e. Certificates of Analysis, MSDS, Certificate of Release, temperature excursion criteria for temperature-controlled products, etc.) for distribution only studies.
Responsible for the interpretation and preparation of preliminary Clinical Supply Shipment Invoice format, database spreadsheets, packaging configurations and processing directives to meet proposal specific shipment requirements.
Responsible for setting up spreadsheets to track inventory, product-specific item codes and shipments to meet SOP’s and cGMP requirements.
Liaison with the Interactive Web Response System vendor to establish distribution requirements before study start up.
Responsible for finalizing preliminary formats and spreadsheets when QA Clinical Supplies Release for Distribution is received from QA.
Responsible for update and maintenance of client specific spreadsheets and shipping document formats to track item codes, inventory and shipments. This is to include, but not limited to, the addition of QA released item codes, removal of depleted or expired item codes.
Submitting updated Clinical Supplies Shipment Invoices to Vice President of Operations or designee for approval for use before processing shipment documents using the revised format.
Manage foreign depot set-up process and act as the primary contact between client and depot.
Provide client or client representative with pro forma to assist in the permit application process for the exportation of study drug product as requested.
Monitor transit of International shipments and notify client of unanticipated delays.
Guide client in selection of monitors and/or packing materials based on temperature sensitivity of product.
Acquire materials for use in the distribution process: temperature monitors, insulated shippers, gel packs, etc. when applicable.
Collaborate with all departments to meet client timelines by coordinating activities between internal departments and clients.
Liaison with Warehouse personnel in meeting timelines for emergency same day shipments or large shipments to be processed for depots.
Monitor inventory levels. Report to Project Management and/or client when inventory is reducing to a predetermined level, when applicable.
Participate in client and/or FDA audits.
Other duties as required.
Knowledge, skills, and abilities: Bachelor’s degree or equivalent
Must have working knowledge of departmental practices and procedures
Excellent interpersonal skills
Excellent reading and writing skills
Excellent communication skills
Excellent mathematical skills
Computer literacy skills
Attention to detail
Knowledge of cGMPs
Familiarity with the pharmaceutical industry
Training methods: In-house training programs
On the job training with an experienced individual