at PCI Pharma Services 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, inspect, or place: Up to 1/4 of the day.
+ Install, place, adjust, apply, measure, use, or signal: None.
+ Ascend/Descend or Work Atop: None.
+ Position self (to) or Move (about or to): None.
+ Communicate or exchange information: 3/4 of the day and up.
+ Detect, distinguish, or determine: Up to 1/4 of the day.
On an average day, the individual can expect to move and/or transport up to 25 pounds
less than 1/4 of the day.
QUALIFICATIONS:
Required:
+ Bachelor’s Degree in a related field and/or 3-5 years related experience and/or training.
+ College Level Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
+ Ability to Travel
+ May have Supervisory Responsibilities
Preferred:
+ Ability to effectively present information to various people as the job requires.
+ Ability to identify and resolve problems in a timely manner.
+ Ability to display excellent time management skills.
+ Ability to work independently and/or as part of a team.
\#LI-RS1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled