Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS. * Works with cross-functional teams to develop specifications and support user testing of IRT ...
Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS. * Works with cross-functional teams to develop specifications and support user testing of IRT ...
Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS. * Works with cross-functional teams to develop specifications and support user testing of IRT ...
Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS. * Works with cross-functional teams to develop specifications and support user testing of IRT ...
Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS. * Works with cross-functional teams to develop specifications and support user testing of IRT ...
Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS. * Works with cross-functional teams to develop specifications and support user testing of IRT ...
Associate Director, Clinical Supply Chain (Remote)
$150K - $185K/yr
Work with Interactive Response Technology (IRT) vendors and systems along with relevant stakeholders to manage clinical trial supplies located at manufacturers, depots, and sites while ensuring ...
New
Associate Director, Clinical Supply Chain (Remote)
$150K - $185K/yr
Work with Interactive Response Technology (IRT) vendors and systems along with relevant stakeholders to manage clinical trial supplies located at manufacturers, depots, and sites while ensuring ...
New
Associate Director, Clinical Supply Chain Management
Bedford, MA · On-site +1
$182K - $199K/yr
Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design ...
Associate Director, Clinical Supply Chain Management
Bedford, MA · On-site +1
$182K - $199K/yr
Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design ...
Associate Director, Clinical Supply Chain
San Francisco, CA · On-site
$214K - $242K/yr
Develop and manage Interactive Response Technologies (IRT) systems * Oversight packaging, labeling, and distribution activities at multiple vendors * Generate and manage clinical labels * Identify ...
Associate Director, Clinical Supply Chain
San Francisco, CA · On-site
$214K - $242K/yr
Develop and manage Interactive Response Technologies (IRT) systems * Oversight packaging, labeling, and distribution activities at multiple vendors * Generate and manage clinical labels * Identify ...
Director, Business Development
$100K - $135K/yr
Endpoint is an interactive response technology (IRT ® ) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to ...
Director, Business Development
$100K - $135K/yr
Endpoint is an interactive response technology (IRT ® ) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to ...
Associate Director, Clinical Supply Chain
Boston, MA · On-site
$197K - $223K/yr
Develop and manage Interactive Response Technologies (IRT) systems * Oversight packaging, labeling, and distribution activities at multiple vendors * Generate and manage clinical labels * Identify ...
Associate Director, Clinical Supply Chain
Boston, MA · On-site
$197K - $223K/yr
Develop and manage Interactive Response Technologies (IRT) systems * Oversight packaging, labeling, and distribution activities at multiple vendors * Generate and manage clinical labels * Identify ...
Endpoint is an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help ...
Endpoint is an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help ...
Support Interactive Response Technology (IRT) design, set up, and maintenance * Participate in IRT Requirements gathering process and provide input for IRT specification documents * Perform User ...
Support Interactive Response Technology (IRT) design, set up, and maintenance * Participate in IRT Requirements gathering process and provide input for IRT specification documents * Perform User ...
Support Interactive Response Technology (IRT) configuration and testing activities, including specification review, UAT coordination, and go-live readiness in partnership with Clinical Operations and ...
Support Interactive Response Technology (IRT) configuration and testing activities, including specification review, UAT coordination, and go-live readiness in partnership with Clinical Operations and ...
Sr. Manager, Clinical Supply
Rockford, IL · On-site
Support Interactive Response Technology (IRT) design, set up, and maintenance * Participate in IRT Requirements gathering process and provide input for IRT specification documents * Perform User ...
Sr. Manager, Clinical Supply
Rockford, IL · On-site
Support Interactive Response Technology (IRT) design, set up, and maintenance * Participate in IRT Requirements gathering process and provide input for IRT specification documents * Perform User ...
Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality. Understands IRT standards and PMD requirements ...
Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality. Understands IRT standards and PMD requirements ...
Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality. Understands IRT standards and PMD requirements ...
Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality. Understands IRT standards and PMD requirements ...
Provide input into User Requirement Specifications of Interactive Response Technology (IRT) medication management module and complete User Acceptance Testing if required. * Review IRT strategy to ...
Provide input into User Requirement Specifications of Interactive Response Technology (IRT) medication management module and complete User Acceptance Testing if required. * Review IRT strategy to ...
Associate Director, Clinical Supplies
San Diego, CA · On-site +1
Experience with Interactive Response Technology (IRT) platforms. * Strong project management, vendor management, and cross-functional collaboration skills. * Excellent written and verbal ...
Associate Director, Clinical Supplies
San Diego, CA · On-site +1
Experience with Interactive Response Technology (IRT) platforms. * Strong project management, vendor management, and cross-functional collaboration skills. * Excellent written and verbal ...
Project Manager
$85K - $100K/yr
Endpoint is an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help ...
Project Manager
$85K - $100K/yr
Endpoint is an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help ...
Senior Demand and Supply Manager
OH · Remote
Provide input into User Requirement Specifications of Interactive Response Technology (IRT) medication management module and complete User Acceptance Testing if required. * Review IRT strategy to ...
Senior Demand and Supply Manager
OH · Remote
Provide input into User Requirement Specifications of Interactive Response Technology (IRT) medication management module and complete User Acceptance Testing if required. * Review IRT strategy to ...
We have an incredible opportunity for a Clinical Systems Specialist to join ICON's Interactive Response Technology (IRT) team. The Clinical Systems Specialist will play a pivotal role in designing ...
We have an incredible opportunity for a Clinical Systems Specialist to join ICON's Interactive Response Technology (IRT) team. The Clinical Systems Specialist will play a pivotal role in designing ...
Senior Demand and Supply Manager
PA · Remote
Provide input into User Requirement Specifications of Interactive Response Technology (IRT) medication management module and complete User Acceptance Testing if required. * Review IRT strategy to ...
Senior Demand and Supply Manager
PA · Remote
Provide input into User Requirement Specifications of Interactive Response Technology (IRT) medication management module and complete User Acceptance Testing if required. * Review IRT strategy to ...
Freelance Irt Interactive Response Technologies information
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Senior Manager Clinical Drug Supply & Logistics
Tarrytown, NY • On-site
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 24 days ago
Key responsibilities
Oversee the forecasting, planning, and management of investigational product (IP) supply requirements for multiple clinical trials.
Manage the IP distribution process, including shipments, inventory tracking, expiry management, and return/destruction activities.
Coordinate with cross-functional teams and external vendors to ensure timely, compliant, and quality supply chain activities for clinical studies.
Regeneron rating
8.5
Based on 44 frontline employees who took The Breakroom Quiz
19th of 86 rated pharmaceutical
Job description
The Senior Manager, Clinical Drug Supply & Logistics is responsible for providing oversight of individual or multiple clinical programs, forecasting Investigational Product (IP) supply requirements for multiple clinical trials, and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs / WPDs. Contributes to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability).
When & where:
- Location: Armonk, NY / Warren, NJ / Cambridge, MA
- Work model/flexibility: in office 3-4 days per week
Discover your role:
Supply Planning
- Serves as lead drug supply manager of a program and/or individual studies for the functional area in supply planning, including demand forecasting according to IOPS requirements.
- Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan.
- Works with clinical drug supply management to determine resourcing needs.
- Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals.
- Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines.
Inventory tracking
- Manages and oversees investigational product (IP) inventory strategy; advises supply management team of potential shortages and defines resupply activities based on usage trends and projections.
Shipments
- Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process.
IVRS
- Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.
- Works with cross-functional teams to develop specifications and support user testing of IRT systems provided by 3rd party vendors.
- Leads effort for clinical supply management functionality.
- Monitors and manages clinical supply activities through IRT from study start-up through study closure.
Returns & Destruction
- Develops strategy and oversees drug return and destruction activities.
Expiry Management
- Develops resupply strategies based on stability and shelf-life of clinical supplies.
- Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
Ancillary & Comparator Supplies
- Coordinates with other functional areas, including Regulatory, Medical Director, Forecasting & Planning, and IOPS to define ancillary and/or comparator supply strategy.
- Develops plans for supplying clinical study sites with ancillary and/or comparator supplies, either through in-house initiated supply or working with supply vendors.
Documentation
- Provides input to drug kit randomization specifications and reviews and approves master kit lists.
- Designs, reviews, and approves IP-related study tools (for clinical study teams and investigative site use), as needed.
- Supports inspection team in preparation for and during regulatory agency inspection. May represent Clinical Drug Supply & Logistics during regulatory agency inspections.
Study Team Interaction
- Represents Clinical Drug Supply & Logistics on cross-functional study team (s) and/or sub-team(s).
- Prepares or provides input into IP-related content for training materials and coordinates training on study procedures; In collaboration with the CTM for study, provides input into IP-related study specific working practices; Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; Develops, manages, and maintains relationships with external partners; Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues.
Budget Management
- Provides input into budgets, SoWs, contracts and timelines for IP-related services.
- Creates RFPs, reviews quotes, and awards third-party vendors for distribution services.
- Responsible for distribution vendor budget management (invoice review/approval, change orders, reconciliation); reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated.
Vendor Management
- Leads management of IP service vendors (performance, quality, timelines, deliverables, costs)
- Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS)
- Provides input, reviews, and approves vendor study specifications for IP-related activities.
- Serves as point of escalation for vendor-related IP issues as they arise.
- May require 25% travel
Staff Management
- May supervise staff.
- May mentor or coach junior Clinical Drug Supply & Logistics staff.
Process Initiatives
- Develops and implements process initiatives in accordance with business needs.
Metrics
- Tracks metrics related to drug supply processes and staff.
Training
- Provides assistance in training and development as needed.
Reporting
- Compiles and reports supply status to study teams and senior management
Problem solving
- Applies knowledge of company policies and standard practices to resolve problems.
This role requires:
- A minimum of Bachelors' degree and 8 years of relevant experience in the biotechnology/pharmaceutical industry, with 5 years minimum in clinical supply management.
- Masters/MBA/PharmD with 5+ years of relevant industry experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$134,400.00 - $219,200.00
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About Regeneron
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
5,001 - 10,000 Employees
Headquarters location
Tarrytown, NY, US
Year founded
1988