"Alerted.org

Job Details:

Duration:** **12** **months contract

Description:

+ The Global Study Planner (GSP) has a pivotal role and supports all aspects of Demand and Supply Planning processes. The GSP Ensures Finished Drug Product supplies from study start throughout last patient dose and is involved throughout the durations of the clinical studies and programs until study closure. The study planner is responsible for ensuring supply and monitoring inventory at all central locations and hospitals per study plan while minimizing product waste.

Responsibilities:

+ Under minimum direction, the GSP manages the following responsibilities for assigned clinical studies.

+ Manage forecast demand and supply for clinical studies worldwide

+ Translate Clinical Development product requirements into executable global supply plan, and updates planning systems to reflect the product requirements as applicable.

+ Responsibilities will include gathering demand requirements and driving production for Pre-Clinical and Clinical.

+ Utilize systems and tools autonomously to effectively manage studies, such as the Forecasting system, SAP, hospital inventory and dosing system, smart sheets, dashboard controls.

+ Lead forecast meetings, including key partner meetings, to ensure the adequacy of supply/re-supply strategies and agreements when vital

+ Develop project plans, timelines and presents as needed.

+ Actively participate in cross functional planning meetings to ensure that program/project priorities needs and timelines are met

+ Serve as the primary interface with Clinical Development, Quality, and Regulatory Affairs to ensure coordination of all activities necessary to maintain the forecast and ensure an adequate supply plan

+ Maintain inventory levels as required at the depots and the clinics to ensure uninterrupted supply

+ Initiate production and stock transfers request on-time to meet labeling, packaging, and shipment of supplies.

+ Effectively and accurately determines pack order ratios of various concentrations, volume and timing of labeling/packaging.

+ Determines shipments volumes and timing of supplies.

+ Effectively and consistently maintains determined levels of inventory at the depot and clinics.

+ Promptly identify and advance risks to study timelines or clinical supplies, from a supply chain perspective to all key partners and internal management

+ Monitors indicators (e.g., Safety, Quality, Delivery, Inventory, Productivity) to gauge performance make necessary adjustments and balance the right amount of inventory with the scrap risk and management guidance on inventory levels.

+ Resolve logistical conflicts impacting studies and R&D milestones ensuring that supplies are not on the critical path

+ Support the Supply Chain business process by identifying opportunities and providing key potential solutions that will provide automation, advanced analytics, and insights to support strategic decision making

+ Manages quality documents and records according to GxPs, SOPs, and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate) principles in a timely manner.

+ Identifies and communicates when controlled documents (e.g., TRNQs, GDEs, SOPs) need to be revised to comply with regulatory requirements or to clarify a work process

+ Prepare and communicate regular updates to key stakeholders including senior management

+ Serves as a subject matter expert on operational processes and systems within their area of expertise

+ Follows GxPs (Good Practices) and SOPs (Standard Operating Procedures) when performing tasks

+ Supports leadership and the team in preparing for internal, partner and regulatory audits

Top Must Have Skill Sets:

+ SCPM and smart sheet experience preferred

+ Excel is required

+ Experience in using ERP systems, preferably SAP

+ Demand Forecast, Supply Chain Planning experience, Pharmaceutical preferred

+ Experience working in a regulated environment, preferable pharmaceutical, GMP environment, and knowledge of regulatory guidelines impacting clinical supplies (i.e. GxP, GDP guidelines, GMP guidelines, ICH guidelines, Clinical Trial Directive)

+ Strong communication, verbal & written, presentation and analytical skills. Effective influencing and leadership skills.

+ Ability to operate in a team based environment

Day to Day Responsibilities:

+ Under minimal supervision, manage demand and supply of Pre-Clinical and Clinical studies/programs. Responsibilities will include gathering demand requirements and driving production of Pre-Clinical and Clinical Investigational products, as well as tracking usage and inventory. Create and provide multiple planning scenarios based on various combinations of inputs and variables, as required. Success will be determined by ensuring the correct levels of product demand is available at all depots globally and at the clinics while minimizing scrap risk.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.