Regulatory Submissions & Data Intelligence Lead

Johnson Johnson; Spring House (PA); Ibrido; USD 130.000 - 160.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead regulatory submission strategies for clinical study data. The role collaborates with data management, statistics, and regulatory affairs to ensure compliant, timely submissions across multiple programs.

The successful candidate develops innovative solutions aligning with internal strategy and regulatory requirements, coaching junior staff and driving

Competenze

• Expertise in clinical data standards and regulatory submission requirements.
• Experience guiding data management and statistical programming for submissions.
• Strong collaboration across stakeholders in regulatory affairs and IDAR.

Mansioni

• Provide expert guidance on regulatory submission requirements and strategies for clinical study data.
• Identify critical submission information and interpret it for IDAR processes.
• Define IDAR submission requirements and rules.
• Serve as the single point of contact for data management, clinical/programming, and global regulatory affairs on deliverables.
• Coach/junior colleagues and align goals with Credo and leadership imperatives.

Conoscenze

Regulatory submissions

Clinical data standards

Cross-functional leadership

Data management

Regulatory intelligence

Descrizione del lavoro

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead regulatory submission strategies for clinical study data. The role collaborates with data management, statistics, and regulatory affairs to ensure compliant, timely submissions across multiple programs.

The successful candidate develops innovative solutions aligning with internal strategy and regulatory requirements, coaching junior staff and driving