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Johnson & Johnson is a global healthcare company working across innovative medicine and medical technology. Its teams develop solutions in oncology, immunology, neuroscience, specialty ophthalmology, interventional care, and orthopaedics, combining science and technology to address complex health needs. The company also emphasizes health equity, environmental sustainability, diversity, and inclusion as it serves providers, patients, and communities worldwide.
Submissions and Regulatory Intelligence Manager
Lead clinical data standards and regulatory intelligence for Johnson & Johnson’s medicines portfolio. Drive SDTM and ADaM submission readiness, compliance, and cross-functional delivery across clinical development teams.
Description
- Advance the Clinical Data Standards organization through strategic programs and innovative initiatives
- Oversee standards, projects, programs, and processes in accordance with internal priorities and regulatory expectations
- Create solutions that give study teams reliable, timely, and consistent clinical data standards
- Recommend process improvements and help shape and integrate supporting technologies
- Mentor and train junior colleagues on clinical data standards and their responsibilities
- Advise IDAR and, where relevant, GD on clinical study data submission requirements and regulatory strategies
- Track new and revised guidance from health authorities and industry bodies
- Assess and interpret study data submission information needed for IDAR submission procedures and workflows
- Act as the central contact for submission deliverables across data management, clinical and statistical programming, and global regulatory affairs
- Keep current on authority guidance and validation and compliance requirements for submission packages, including SDTM and ADaM
- Help manage tools, systems, checklists, and templates used to verify data package compliance
- May lead the Submission Center of Excellence, allocate work, and confirm SDTM, ADaM, and documentation readiness after database lock
Requirements
- Bachelor’s degree in a scientific, technology, or healthcare field, or equivalent professional experience
- An advanced degree such as a master’s or doctorate is preferred
- Six or more years of relevant pharmaceutical or scientific experience in areas such as data management, biostatistics, or clinical or statistical programming
- Strong command of applicable regulatory requirements, including GCP and ICH
- Strong command of industry standards, including SDTM and ADaM
- Experience supporting NDA or BLA submissions is advantageous
- Strong written and verbal communication abilities
- A proven customer-focused and solution-oriented approach
- Interpersonal ability to develop effective relationships with internal and external partners
- Experience leading cross-functional initiatives
- A record of leadership in decision-making and problem-solving
- Fluent spoken and written English
Benefits
- Competitive compensation and a broad benefits offering
- Flexible work arrangements
- Opportunities for professional growth
- Annual bonus with a target determined by pay grade and location
- Sales commission eligibility
- Paid vacation
- At least 12 weeks of parental leave
- Bereavement leave
- Caregiver leave
- Paid volunteer leave
- Well-being reimbursement
- Financial, physical, and mental health programs
- Service milestone and recognition awards
- Insurance coverage for employees and, in some locations, eligible dependents
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