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Submissions & Regulatory Intelligence Manager
Johnson & Johnson. Establish programs and innovative strategies that advance the Clinical Data Standards organization .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in Clinical Data Standards, including SDTM and ADaM, with a strong focus on regulatory compliance and submission processes. Proven ability to lead cross-functional projects and coach junior colleagues while maintaining effective communication with stakeholders.
Highest-signal resume keywords
Clinical Data Standards ManagementRegulatory Submission ExpertiseSDTM and ADaM KnowledgeLeadership in Cross-Functional ProjectsAdvanced Degree in Scientific Discipline
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Data StandardsRegulatory RequirementsData ManagementBiostatisticsStatistical ProgrammingRegulatory SubmissionsGCP KnowledgeICH KnowledgeProblem SolvingDecision Making
Soft Skills
Written CommunicationVerbal CommunicationCustomer FocusInterpersonal SkillsSolution-Oriented Mindset
Tools & Technologies
Submission Center of ExcellenceCompliance Checking ToolsData Submission TemplatesChecklists
Industry Keywords
Pharmaceutical ExperienceScientific ExperienceClinical Study DataNDABLA
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Establish programs and innovative strategies that advance the Clinical Data Standards organization
- Manage Clinical Data Standards standards, projects, programs, and processes in line with internal strategy and regulatory requirements
- Develop solutions providing accurate, timely, and consistent clinical data standards to study teams
- Communicate process improvement ideas and support the design and integration of technologies
- Coach and train junior colleagues in clinical data standards application and responsibilities
- Provide expertise to IDAR and, where applicable, GD, on clinical study data regulatory submission requirements and strategies
- Monitor newly released or updated Regulatory Health Authority and industry guidance
- Identify and interpret clinical study data submission information critical to IDAR submission processes and procedures
- Serve as the single point of contact for data submission deliverable requirements across data management, clinical and statistical programming, and global regulatory affairs
- Maintain expertise in regulatory authority guidance and validation/compliance rules for data submission packages, including SDTM and ADaM packages
- Support ownership of tools, systems, checklists, and templates facilitating data package compliance checking
- Potentially lead the Submission Center of Excellence, distribute workload, and ensure SDTM, ADaM, and documentation submission-readiness after database lock
Requirements
What you’ll need- Bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience
- Advanced degrees preferred (e.g., Master, PhD)
- At least 6 years of relevant pharmaceutical/scientific experience in a related discipline, such as data management, biostatistics, clinical or statistical programming
- Expert knowledge of relevant regulatory requirements, such as GCP and ICH
- Expert knowledge of industry standards, such as SDTM and ADaM
- Experience with regulatory submissions (NDA, BLA) is an asset
- Demonstrated written and verbal communication 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
Comp & perks- Competitive salary and extensive benefits package
- Flexible working environment
- Career development opportunities
- Annual bonus with set target depending on pay grade/location
- Sales commissions
- Vacation days
- Parental leave for a minimum of 12 weeks
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Well-being reimbursement
- Programs for financial, physical and mental health
- Service anniversary and recognition awards
- Insurance plans for employees and, in some locations, eligible dependents