Strategic Submissions & Regulatory Intelligence Lead

Johnson Johnson; High Wycombe; Hybrid; GBP 90,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data standards initiatives. You will provide expert guidance on regulatory submission requirements, collaborate with partners, and drive standardization across trials while ensuring compliance.

The role may be based in multiple UK/EU locations with hybrid work and frequent cross-functional interaction to advance regulatory strategies and data quality.

Responsibilities

• Acts as top-level specialist to establish programs and innovative strategies for Clinical Data Standards
• Manages standards, projects, programs, or processes for Clinical Data Standards in line with internal strategy and regulatory requirements
• Participates in development of solutions to provide accurate, timely, and consistent clinical data standards
• Communicates ideas for process improvement and supports integration of new technologies
• Coaches and trains junior colleagues in clinical data standards application
• Integrates Credo and Leadership Imperatives into team goals and decisions

Job description

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data standards initiatives. You will provide expert guidance on regulatory submission requirements, collaborate with partners, and drive standardization across trials while ensuring compliance.

The role may be based in multiple UK/EU locations with hybrid work and frequent cross-functional interaction to advance regulatory strategies and data quality.