Distribution Project Manager

Direct-Hire
New Jersey
Posted 1 month ago

Overview: 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.

Responsibilities:

  • Initiate and/or participate in preliminary discussions with assigned client proposals regarding a plan for the distribution of study materials before shipping begins
  • Include Vice President of Operations and the Distribution Associates in all email correspondence with assigned clients to assure distribution office personnel is current as to status of study requirements and distribution of study supplies
  • 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, item codes and shipments to meet SOP’s and cGMP requirements
  • Responsible for submitting the Authorization Signature Form to the client for completion and obtaining the completed version from the client before shipments begin, when applicable
  • Liaison with the IVRS vendor to establish distribution requirements before study start up
  • Finalizing preliminary formats and spreadsheets when QA Clinical Supplies Release for Distribution is received from QA
  • Responsible for submitting the QA release with a copy of the 4-part Clinical Supplies Shipment Invoice (CSSI) format to the Vice President of Operations or designee for approval before CSSI format is used in processing the first shipment
  • Responsible for update and maintenance of client specific spreadsheets and CSSI 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 VP of Operations or designee for approval for use before processing shipment documents using the revised format
  • Provide Client with Information concerning the importation of study drug if requested
  • For International studies, coordinates with client the country specific information concerning the exportation of study supplies if requested
  • Provide client 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 packaging materials based on temperature sensitivity of products
  • 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
  • Collaborate with Vice President of Operations and Distribution Shipment Auditor to review proposal specific shipment documentation requirements and complete or verify requirements have been added to the Auditing checklist
  • 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

Requirements:

  • 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
  • English literacy
  • Excellent mathematical skills
  • Computer literacy skills
  • Attention to detail
  • Knowledge of cGMP’s
  • Familiarity with the pharmaceutical industry

Job Features

Job CategoryOperations

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