Regulatory Submissions & Data Standards Lead

Johnson Johnson; Beerse; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data regulatory submission strategies and ensure consistency of standards across trials. This role collaborates with internal teams and external partners to drive compliant data submissions and program success.

The candidate will serve as a key contact across data management, clinical and statistical programming, and regulatory affairs, coaching junior

Responsibilities

• Provide significant expertise to the IDAR department in clinical study data regulatory submission requirements and strategies.
• Identify clinical study data submission information critical to IDAR submission processes and procedures.
• Be the single Point of Contact for data management, clinical and statistical programming, and global regulatory affairs for submission deliverables.
• Coach and trains junior colleagues in clinical data standards application and responsibilities.

Job description

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data regulatory submission strategies and ensure consistency of standards across trials. This role collaborates with internal teams and external partners to drive compliant data submissions and program success.

The candidate will serve as a key contact across data management, clinical and statistical programming, and regulatory affairs, coaching junior