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Lilly
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Indianapolis, Indiana
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, including authoring and/or reviewing relevant submission document sections
Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
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Lilly
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Indianapolis, Indiana
...
pharmacometrics to impact across this portfolio from early discovery to clinical submission and beyond.
We
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
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Lilly
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Indianapolis, Indiana
...
project personnel to enable timely completion of submission milestones leading to health authority ... function, CMC team and/or submission timing.
• Provides consultation across global regulatory
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
review of molecule specific CMC development strategies and submission content
Makes risk-based ... in supporting CMC functions with regulatory submission experience)
OR
Advanced degree
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Lilly
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Indianapolis, Indiana
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submission package. The CP serves as a scientific resource for study teams, departments, and others as ... pharmacology including early phase exploratory and late phase biopharm submission studies.
The core job
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Lilly
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Indianapolis, Indiana
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
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Lilly
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Indianapolis, Indiana
...
study design, execution, submission, and registration while maintaining close partnerships with relevant
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Lilly
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Indianapolis, Indiana
...
.
Support Affiliate Labeling Responsible Person (ALRP) in submission and implementation activities related ... , including communication with affiliates for submission activities related to the ARF process and samples and
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
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Lilly
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Indianapolis, Indiana
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messaging and content of global regulatory submission documents. Provide regulatory direction in the ... Canada_ strategy for submission and amendments for IND, IDE, CTA
Determineand
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Lilly
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Indianapolis, Indiana
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messaging and content of global regulatory submission documents. Provide regulatory direction in the ... Canada_ strategy for submission and amendments for IND, IDE, CTA
Determineand
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Lilly
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Indianapolis, Indiana
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candidates to support clinical trials, regulatory submission, and product commercialization. The position
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Lilly
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Indianapolis, Indiana
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in clinical drug development from data collection through analysis/integrated databases/submission
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
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Lilly
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Indianapolis, Indiana
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Author sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for
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Lilly
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Indianapolis, Indiana
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appropriate research, submission, registration and commercialization support teams.
• Visibly active in ... medical expert.
Regulatory/ submission responsibilities
•Ensures that clinical data
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...
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Lilly
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Indianapolis, Indiana
...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a g
...