Author Jobs in Evansville
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Yoh, A Day & Zimmermann Company-Evansville
and SOP’s.
• Maintain current knowledge of US and international quality regulations
• Author or perform peer review of annual product quality reviews.
• Provide support for regulatory agency (i.e. FDA, HC, TGA, EU, etc.) on-site audits, as required.
• Must...
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Sun Pharmaceuticals, Inc-Evansville
on development programs and multiple studies.
Author statistical analysis plan, TFL shells and other study-related statistical documents.
Review AdaM Specification, oversee the generation of AdaMs and TFLs and ensure timely high-quality deliverables.
Plan...
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mindmatch.ai -
Evansville
Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products.
• Ensure data integrity and scientific consistency in all testing. Promote data analysis using advanced statistical...
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pharmiweb.jobs -
Takeda Pharmaceutical-Cambridge, 918 mi from Evansville
topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan...
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Evansville
capabilities and technologies to support product development pipeline.
• Specify, design, and procure specialized test fixtures
• Author and review rigorous technical documents for inclusion in DHFs, to support regulatory submissions, and to address...
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pharmiweb.jobs -
Takeda Pharmaceutical-Cambridge, 918 mi from Evansville
on product specific value evidence topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments...
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Evansville
and develop talent to meet DDSP business requirements. Plus develop robust succession plans that provide career opportunities for individuals while supporting business resiliency.
• Provide Primary Packaging budget input for projects.
• Author and or review...
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pharmiweb.jobs -
Takeda Pharmaceutical-Cambridge, 918 mi from Evansville
on product specific value evidence topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments...
Read more
Takeda Pharmaceutical-Cambridge, 918 mi from Evansville
on product specific value evidence topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments...
Read more
Takeda Pharmaceutical-Cambridge, 918 mi from Evansville
on product specific value evidence topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments...
Read more
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