Company Overview At Johnson Beerse, Belgium; Allschwil, Switzerland; Leiden, Netherlands; or Spring House/Raritan/Titusville, United States (Hybrid / 3 days onsite per week preferred). Requisitions Belgium/Netherlands - Requisition Number: R-103242 United Kingdom - Requisition Number: R-101253 Switzerland - Requisition Number: R-103247 United States - Requisition Number: R-103251 Purpose Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization. Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements. Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams. Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards. Coaches and trains junior colleagues in clinical data standards application and responsibilities. Integrates Johnson e.g., data management, biostatistics, clinical or statistical programming! Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM) Experience with regulatory submissions (NDA, BLA) is an asset Demonstrated written and verbal communications skills Demonstrated customer focus and solution-oriented experience Demonstrated interpersonal skills to build relationships with internal and external business partners Demonstrated leadership on cross-functional projects Demonstrated leadership in decision making and problem solving Excellent spoken and written English Benefits We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. Equal Opportunity Statement Johnson
Submissions & Regulatory Intelligence Manager employer: 7360-Janssen-Cilag Limited Legal Entity
Janssen-Cilag Limited is an exceptional employer that fosters a collaborative and innovative work culture in High Wycombe, England. With a strong commitment to employee development, we offer extensive growth opportunities through mentorship and training, ensuring our team members thrive in their careers while contributing to impactful clinical programming strategies. Our focus on operational excellence and compliance not only enhances the quality of our work but also creates a rewarding environment for those passionate about advancing healthcare.
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7360-Janssen-Cilag Limited Legal Entity Recruitment Team
