CLINICAL SUPPLY SPECIALIST / PLANNER 100% Remote. TOP 3 " Must Haves "
Knowledge of IRT.
Ability to model in Excel.
Knowledge of clinical labeling/packaging operations.
Client is seeking a talented, independent, and highly motivated Clinical Supply Chain Manager with expertise in supply chain management to join our Pharmaceutical Sciences group.
Responsible for day-to-day activities related to managing the supply of Clinical Trial Material (CTM) through all stages of clinical development including packaging, labeling, and distribution.
This role will also support and advise Clinical Operations, Regulatory, Quality, and clinical sites on all aspects of CTM and comparator products as applicable.
Support clinical supply activities for on-going and new clinical trials for on-time delivery, including demand forecasting, trial monitoring & resupply planning, IRT set-up and distribution activities.
Design and execute packaging and labelling campaign activities including but not limited to; timeline management, documentation approval, and coordination with Contract Development and Manufacturing Organizations (CDMO).
Support management of Contract Development and Manufacturing Organizations (CDMO) and provide comprehensive information about clinical supplies.
Ensure continuous supply of clinical trial material for ongoing studies within the US and ex-US locations.
Ensure on time startup of new studies by having supplies available as required.
Manage and track manual on-time distribution to US and ex-US clinical sites.
Develop efficient process and tracking report for manual shipments.
Review clinical protocols and design appropriate supply chain strategy.
Oversee a variety of logistics issues, including but not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing.
Act as liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies.
Drive timelines of requested bulk manufacturing, packaging, labeling and final release to meet forecasted demand.
Develop, maintain and present Clinical Supply Chain dashboard to be shared with upper management.
Establish and maintain process with Accounts Payable and Legal to effectively manage on-time approvals of purchase orders, change orders and invoices of Contract Development and Manufacturing Organizations (CDMO).
Work collaboratively and transparently with Clinical Operations, Technical Sciences, Quality Assurance and Regulatory Affairs.
BS degree with 3-5 years' experience in a Supply Chain Planning role in a Biotechnology or Pharmaceutical environment.
Must Have Knowledge of IRT, Ability to model in Excel, Knowledge of clinical labeling/packaging operations.
Excellent project management, organizational and communication skills.
Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements is a plus.
Experience in cold-chain clinical supply distribution is a plus.
Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.
Experience working with QP, IRTs, depots with global IP distribution.
Project Management Professional certification is a plus.
Experience managing contract packaging and labeling organizations (strongly preferred).
Experience in pediatric packaging and labeling requirements is a plus.
Periodic travel to manufacturing and other partner sites is required (approximately 10% of time), in accordance with applicable COVID-related travel guidelines.
This 6+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-03253
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE