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Johnson & Johnson is seeking a Principal Scientist for SEND submissions, located in Spring House, PA, or La Jolla, CA. The role requires expertise in nonclinical toxicology study data, regulatory submissions, and SEND standards while providing operational readiness and oversight of deliverables.
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Job Summary
The Principal Scientist will own operational readiness and standards alignment for Standard Exchange of Nonclinical Data (SEND) deliverables supporting regulatory submissions.
You will be responsible for serving as the Johnson & Johnson Innovative Medicine (JJIM)'s SEND subject matter expert and functioning as the primary internal and external point of contact for all SEND deliverables.
The role involves managing end-to-end nonclinical SEND submission package readiness, performing validation and data quality workflows, and contributing to strategic initiatives.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking a Principal Scientist for SEND submissions, located in Spring House, PA, or La Jolla, CA. The role requires expertise in nonclinical toxicology study data, regulatory submissions, and SEND standards while providing operational readiness and oversight of deliverables.
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Salary
Base: $117,000.00 - $201,250.00; Bonus/Equity: Eligible for annual performance bonus; Benefits: Medical, dental, vision, life insurance, disability, retirement plan, 401(k), paid time off
Skills & Requirements
Must-have
SEND subject matter expert
nonclinical data standardization
regulatory submission support
data quality workflows
controlled terminology governance
Nice-to-have
AI and Machine Learning initiatives
external standards forums participation
cross-functional collaboration
global matrix organization leadership
Key Requirements
Bachelor's degree in Toxicology, Pharmacology, Biology, or related science
6+ years of relevant experience
Familiarity with regulatory submission requirements