Submissions & Regulatory Intelligence Lead

Johnson & Johnson Innovative Medicine; Spring House (PA); Hybrid; USD 117,000 - 201,000; Full time

Benefits offered by this job

Performance bonus

Medical, dental, vision benefits

401(k) retirement plan

Paid time off 120 hours

Job summary

Johnson & Johnson Innovative Medicine seeks a Submissions & Regulatory Intelligence Manager to lead Clinical Data Standards initiatives across IDAR. You will collaborate with data management, regulatory, and statistics teams to ensure SDTM/ADaM completeness and regulatory alignment.

You will drive strategies, interpret health authority guidance, and mentor staff while coordinating with trial teams globally. This role supports multiple country postings and emphasizes data integrity and compliance.

Qualifications

• Bachelor’s degree in a scientific, technology or healthcare discipline is required or equivalent experience.
• At least 6 years of pharmaceutical/scientific experience in data management, biostatistics, clinical or statistical programming.
• Expert knowledge of regulatory requirements (GCP, ICH) and industry standards (SDTM, ADaM).

Responsibilities

• Act as a top-level specialist to establish programs and strategies for Clinical Data Standards.
• Manage standards and processes for Clinical Data Standards aligned with regulatory requirements.
• Develop solutions to provide accurate, timely, and consistent clinical data standards to study teams.
• Communicate process-improvement ideas and support new technologies integration.
• Coach and train junior colleagues in clinical data standards applications.
• Incorporate Credo and Leadership Imperatives into team goals and decisions.

Skills

Advanced Analytics

Clinical Data Management

Clinical Trials Operations

Data Privacy Standards

Data Savvy

Good Clinical Practice

Innovation

Regulatory Affairs Management

Research Ethics

Technical Credibility

Education

Bachelor’s degree in a scientific, technology or healthcare discipline

Advanced degree preferred (Master, PhD)

Job description

Johnson & Johnson Innovative Medicine seeks a Submissions & Regulatory Intelligence Manager to lead Clinical Data Standards initiatives across IDAR. You will collaborate with data management, regulatory, and statistics teams to ensure SDTM/ADaM completeness and regulatory alignment.

You will drive strategies, interpret health authority guidance, and mentor staff while coordinating with trial teams globally. This role supports multiple country postings and emphasizes data integrity and compliance.