Associate IP Demand Management
Company Name:
Eli Lilly
Company Overview:
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
Responsibilities:
The Clinical Trial Materials Management team is responsible for providing Investigational Product study drug management
services
for global clinical trials in all development phases, including partnering with medical teams to develop compound and study supply plans, package design, label creation, and other deliverables required to initiate a Clinical Trial Material Request. The CTMM team also provides oversight of business processes related to on time study drug delivery at clinical trial sites.
The Demand Management Associate uses the study protocol and other inputs to develop a study-specific supply plan and provides ongoing study drug oversight during the execution phase of the study. The Demand Management Associate is responsible for the upfront planning activity including interaction and communication with the Medical and CM&C teams, development of the Investigational Products supply plan and the study re-supply plan (if applicable), package design, English label text creation, and all deliverables required to initiate a Clinical Trial Material Request. The Demand Associate is also accountable for insuring initial and on-going on time delivery of IP material at clinical sites in compliance with all applicable quality and regulatory requirements.
Forecast and plan Investigational Product material quantities at the study level.
Interpret IP material requirements from the clinical study protocol to develop and maintain study supply plans that cost effectively deliver a high level of patient customer service.
Understand and utilize forecasting techniques and tools for developing and re-evaluating IP material demand.
Design packaging and label text in a way that aligns with protocol objectives, regulatory requirements, and minimizes risk of patient non-compliance.
Develop packaging strategies that optimize patient customer service and overall study cost.
Draft, review, and approve label text that meets study protocol requirements and enables patient compliance.
Write and review regulatory module for label text.
Collaborate with other functional areas (Clinical, CTMS Core team and CM&C teams) to enable clinical research.
Serve as the primary CTMS contact at the study level for the Clinical team. Actively participate and influence study management meetings and discussions.
Review supply plans with the Clinical team to clarify key risks and limitations.
Develop and present IP-related training at
investigator
and affiliate start up meetings.
Understand IVRS/IWRS capabilities and limitations
Proactively identify and mitigate IP supply related risks and issues.
Collaborate with inventory management provider to develop strategy for clinical site supply.
Ensure study inventory management strategy aligns with study supply plan.
Provide pertinent data and information from clinical study meetings to inventory management provider.
Basic
Qualifications:
Bachelors Degree or work experience in Supply Chain, Clinical Trials, Pharmaceuticals, or Life Science fields
1
years experience of GMPs/GCPs and other regulations related to CT Materials
Qualified candidates must be legally authorized to be employed in the United States. Eli Lilly and Company does not anticipate providing sponsorship for employment visa status (e.g.H-1B or TN status) for this employment
position
.
Additional Skills/Preferences:
2 years experience in a supply planning or clinical role
Strong proficiency with
computer
applications including Microsoft Office products
Ability to build collaborative relationships between internal functional groups with competing priorities
Effective written and verbal communication skills in multi-cultural settings.
Ability to work in an independent, flexible environment
Must be fluent in English.
ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER
Apply online at:
https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?PartnerId=25428&SiteId=5645&Areq=7224BR&Codes=IMBEstimated Salary: $20 to $28 per hour based on qualifications.
Eli Lilly
Company Overview:
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
Responsibilities:
The Clinical Trial Materials Management team is responsible for providing Investigational Product study drug management
services
for global clinical trials in all development phases, including partnering with medical teams to develop compound and study supply plans, package design, label creation, and other deliverables required to initiate a Clinical Trial Material Request. The CTMM team also provides oversight of business processes related to on time study drug delivery at clinical trial sites.
The Demand Management Associate uses the study protocol and other inputs to develop a study-specific supply plan and provides ongoing study drug oversight during the execution phase of the study. The Demand Management Associate is responsible for the upfront planning activity including interaction and communication with the Medical and CM&C teams, development of the Investigational Products supply plan and the study re-supply plan (if applicable), package design, English label text creation, and all deliverables required to initiate a Clinical Trial Material Request. The Demand Associate is also accountable for insuring initial and on-going on time delivery of IP material at clinical sites in compliance with all applicable quality and regulatory requirements.
Forecast and plan Investigational Product material quantities at the study level.
Interpret IP material requirements from the clinical study protocol to develop and maintain study supply plans that cost effectively deliver a high level of patient customer service.
Understand and utilize forecasting techniques and tools for developing and re-evaluating IP material demand.
Design packaging and label text in a way that aligns with protocol objectives, regulatory requirements, and minimizes risk of patient non-compliance.
Develop packaging strategies that optimize patient customer service and overall study cost.
Draft, review, and approve label text that meets study protocol requirements and enables patient compliance.
Write and review regulatory module for label text.
Collaborate with other functional areas (Clinical, CTMS Core team and CM&C teams) to enable clinical research.
Serve as the primary CTMS contact at the study level for the Clinical team. Actively participate and influence study management meetings and discussions.
Review supply plans with the Clinical team to clarify key risks and limitations.
Develop and present IP-related training at
investigator
and affiliate start up meetings.
Understand IVRS/IWRS capabilities and limitations
Proactively identify and mitigate IP supply related risks and issues.
Collaborate with inventory management provider to develop strategy for clinical site supply.
Ensure study inventory management strategy aligns with study supply plan.
Provide pertinent data and information from clinical study meetings to inventory management provider.
Basic
Qualifications:
Bachelors Degree or work experience in Supply Chain, Clinical Trials, Pharmaceuticals, or Life Science fields
1
years experience of GMPs/GCPs and other regulations related to CT Materials
Qualified candidates must be legally authorized to be employed in the United States. Eli Lilly and Company does not anticipate providing sponsorship for employment visa status (e.g.H-1B or TN status) for this employment
position
.
Additional Skills/Preferences:
2 years experience in a supply planning or clinical role
Strong proficiency with
computer
applications including Microsoft Office products
Ability to build collaborative relationships between internal functional groups with competing priorities
Effective written and verbal communication skills in multi-cultural settings.
Ability to work in an independent, flexible environment
Must be fluent in English.
ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER
Apply online at:
https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?PartnerId=25428&SiteId=5645&Areq=7224BR&Codes=IMBEstimated Salary: $20 to $28 per hour based on qualifications.
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