At Johnson Beerse, Belgium; Allschwil, Switzerland; Leiden, Netherlands; or Spring House/Raritan/Titusville, United States (Hybrid / 3 days onsite per week preferred). Please note that this role is also available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium/Netherlands - Requisition Number: R-103242 United Kingdom - Requisition Number: R-101253 Switzerland - Requisition Number: R-103247 United States - Requisition Number: R-103251 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 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. Johnson
Submissions & Regulatory Intelligence Manager employer: Johnson & Johnson Innovative Medicine
At Johnson & Johnson Innovative Medicine, we pride ourselves on fostering a collaborative and inclusive work culture that empowers our employees to thrive. As a Regulatory Medical Writer II, you will benefit from our commitment to professional development, with ample opportunities for growth and learning in a dynamic environment. Located in the UK, our hybrid work model offers flexibility while allowing you to contribute to impactful projects that advance healthcare globally.
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Johnson & Johnson Innovative Medicine Recruitment Team
