at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Manages all storage and distribution activities for assigned clinical customer projects to ensure critical shipment deadlines are met, global distribution tasks are completed within committed timelines, budget and in accordance with customer expectations and pharmaceutical regulatory requirements. Manage and play an integral part in developing strategic customer relationships and individual project success to provide PCI a competitive advantage and increased potential for long term customer relationship and business growth.. Fill role of Lead Global Project Manager between PCI Global facilities where required. Diligently manages significant matters pertaining to assigned projects to "Provide the industry's leading customer experience" supporting PCI Clinical Service's long term growth and success. Responsible for all activities associated with a Clinical Distribution project.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Primary customer contact to coordinate shipment of investigational drug product to Clinical dosing sites and testing facilities. Includes understanding of timing, temperature control and documentation needs for shipment destinations within the US as well as globally. Extensive external contacts on a professional level.
Prepare the Logistics Management Document/LI to serve as internal instructions for correct storage and shipping conditions, required documentation and any special instructions for accurate and timely execution of investigational drug shipment order per the customer's specific study.
Assist in the development of detailed pack construction to ensure that the packaging is designed in a way that allows for efficient storage and distribution.
Coordinates project activities by leading the Distribution Project Team and through working closely with the Clinical Packaging Project Management team as well as internal and external customers. Proactively anticipates customer needs and potential obstacles, independently problem solves and drives actions to resolve any issues that arise with a high level of responsiveness and urgency.
Interacts with customers, vendors, and internal PCI colleagues to deliver service excellence and ensure performance expectations are met or exceeded on a consistent basis. Includes participation in weekly or periodic PCI lead calls with customer to review project milestones, upcoming PCI and customer deliverables and discuss any potential obstacles to the storage or shipment processes.
Coordinates all distribution activities from order receipt, through shipment and billing per customer agreed upon requirements. Include set-up, communication and management of 3rd party global storage and distribution facilities for countries in which PCI does not have a distribution facility.
Sets up internal documentation to facilitate return of the investigational drug product from Clinical Trial sites, agreed upon accountability of drug product and corresponding drug product destruction at close of Clinical Trial.
Manages all Clinical Trial project close out activities.
Facilitates the billing of all activities involved with storage, distribution, returns, destruction, and project close-out activities.
Coordinates customer visits, participates in periodic customer business review meetings and facilitates activities as per customer needs.
Reviews Quotes to ensure scope is appropriate. Initiates change orders where necessary. Monitors project budget and scope creep.
Coach, mentor, and supervise the Associate Clinical Project Managers
Provide support to business development and estimation regarding new quotations and resupplies.
Provide the client with the highest level of professionalism, quality of work, communication/responsiveness, and status of deliverables.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor.
Special Demands:
Stationary Position: From 1/2 to 3/4 of the day.
Move, Traverse: Up to 1/4 of the day.
Operate, activate, use, prepare,... For full info follow application link.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
