Submissions & Regulatory Intelligence Manager
Johnson & Johnson
Johnson & Johnson seeks a Submissions & Regulatory Intelligence Manager to lead clinical data standards strategy and regulatory compliance initiatives within the Innovative Medicine division. The role combines individual expertise with collaborative leadership across multiple internal and external partners, ensuring consistency in clinical trial data submission packages.
Responsibilities
- Provide expert guidance on clinical data standards and regulatory submission strategies to internal teams
- Monitor and interpret newly released regulatory health authority guidance documentation
- Serve as primary point of contact for data submission deliverable requirements across study teams
- Lead or support the Submission Center of Excellence for study-level submission readiness review
- Coach and develop junior colleagues in clinical data standards application and compliance
Requirements
- Bachelor's degree in scientific, technology, or healthcare discipline; advanced degree preferred
- At least 6 years of pharmaceutical or scientific experience in related discipline
- Deep expertise in regulatory health authority guidance and submission requirements
- Knowledge of SDTM/ADaM submission packages and compliance standards
- Experience with clinical data management and regulatory submission processes
- Project and program management capabilities with multiple stakeholder coordination
L'offre d'emploi a été publiée il y a 4 jours
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