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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.
विवरण
- 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
आवश्यकताएँ
- 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
लाभ
- 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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