Principal Scientist, Send Submissions

Johnson & Johnson

Spring House, Pennsylvania, United States of America
Base: $117,000.00 - $201,250.00; bonus/equity: eli...
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Send subject matter expert
Nonclinical data standardization
Regulatory submission support
** 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. **

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

** 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. **

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
  • Knowledge of Good Laboratory Practice
  • Strong written and verbal communication skills

Work Rights

Not specified

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