Manager, Clinical Supply Planning and Logistics
A major global pharmaceutical corporation focused on the discovery, the development, and the commercialization of products for the treatment of cancer.
Position:Manager, Clinical Supply Planning and Logistics
Location: Basking Ridge, NJ
Duration: 4 months
* Develops and updates Study Supply Plans in close communication with CSO project Managers.
* Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.
* Manages CMO documentation reviews (i.e, packaging Batch Record) review and approval process with Quality Assurance and other CSO personnel.
* Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
* Oversees clinical site and depot inventories through the course of a study and ensures alignment with supply forecast and study requirements. Reviews IRT specifications, participates in UAT as requested and maintains settings in IRT to align with supply plans.
* Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.
* Vendor Management & supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship Assists in the creation of SOP's and work instructions specific to CSO Supply Planning as requested.
* Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents Supports the CSO PM in executing additional operational and logistical duties as discussed and agreed to by management.
* Acts as point of contact for operational clinical supply matters during the course of a clinical trial including facilitating the review of temperature excursions.
* Good understanding of Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international).
* Solid knowledge of clinical supply planning, manufacturing, packaging, and labeling.
* Experience in managing third-party contract clinical supply operations/CMO's.
* Experience managing multiple vendors per project required.
* Import/export knowledge desirable.
* Working in a matrixed environment
* Excellent communication, negotiating, and computer skills.
* Strong team orientation.
* Experience with IRT highly preferred
BS/BA required. Degree in pharmacy or related field preferred. MS or PharmD highly beneficial.
Sthree US is acting as an Employment Business in relation to this vacancy.