Aditi Consulting
MCS Supply Chain Senior Associate
Aditi Consulting, Thousand Oaks, California, United States, 91362
Payrate:
$35.00 - $37.00 /hr.
Summary: 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
Qualifications:
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
Pay Transparency:
The typical base pay for this role across the U.S. is:
$35.00 - $37.00 /hr.
As a non-exempt position, this role will be eligible for overtime, at 1.5 times the base rate, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience. Full-time employees are eligible for benefits including medical, dental, and vision benefits, health savings account option for qualified medical plan enrollments, accrual of up to 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, travel reimbursement, accommodations for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement as required by state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC's use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying "STOP" to messages or by contacting privacy@aditiconsulting.com. For information about our collection, use, and disclosure of applicants' personal information as well as applicants' rights over their personal information, please see our Privacy Policy.
#AditiConsulting # 25 - 23552
$35.00 - $37.00 /hr.
Summary: 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
Qualifications:
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
Pay Transparency:
The typical base pay for this role across the U.S. is:
$35.00 - $37.00 /hr.
As a non-exempt position, this role will be eligible for overtime, at 1.5 times the base rate, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience. Full-time employees are eligible for benefits including medical, dental, and vision benefits, health savings account option for qualified medical plan enrollments, accrual of up to 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, travel reimbursement, accommodations for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement as required by state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC's use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying "STOP" to messages or by contacting privacy@aditiconsulting.com. For information about our collection, use, and disclosure of applicants' personal information as well as applicants' rights over their personal information, please see our Privacy Policy.
#AditiConsulting # 25 - 23552