Submissions & Reg. Intelligence Mgr
$117k - $201.25kJohnson & Johnson
Johnson & Johnson seeks a Submissions & Regulatory Intelligence Manager to lead clinical data standards strategy within Innovative Medicine. This role provides expert guidance on regulatory compliance, clinical data submission requirements, and process innovation across multiple internal and external partnerships.
Responsibilities
- Provide expert guidance on regulatory requirements and submission strategies to internal and external partners
- Maintain current knowledge of regulatory health authority guidance and industry standards documentation
- Serve as primary point of contact for data submission deliverable requirements across study teams
- Lead or support Submission Center of Excellence activities ensuring data package submission-readiness
- Coach and train junior colleagues on clinical data standards application and compliance responsibilities
Requirements
- Bachelor's degree in scientific, technology, or healthcare discipline; advanced degree preferred
- At least 6 years of relevant pharmaceutical or clinical data management experience
- Deep expertise in regulatory health authority guidance and data submission standards
- Knowledge of SDTM/ADaM submission packages and compliance requirements
- Experience managing cross-functional teams and serving as subject matter expert
- Strong communication skills for translating regulatory requirements to diverse stakeholders
Vacancy posted 4 days ago
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