Director of Safety Data Operations and Governance jobs in United States
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Johnson & Johnson · 3 hours ago

Director of Safety Data Operations and Governance

Johnson & Johnson is a leader in healthcare innovation, dedicated to improving health through advanced medical solutions. They are seeking a Director of Safety Data Operations and Governance to oversee data management for patient safety insights, ensuring compliance with regulatory standards and facilitating collaboration across various teams.

Hospital & Health Care
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Identify internal and external data sources relevant to patient safety, including but not limited to clinical trials, preclinical studies, and post-market surveillance
Secure access to these data sets in collaboration with cross-functional teams (R&D, Clinical, Regulatory, Quality, IT, Legal)
Develop and implement a governance framework for data use within the EP Organization
Ensure compliance with data privacy, security, and regulatory standards
Maintain documentation of data sources, ownership, and usage guidelines
Partner with Medical Safety Officer, Medical Affairs, Clinical Operations, R&D, Quality, Epidemiology, and Data Science teams to integrate data for safety signal detection and risk assessment
Support development of dashboards and analytics tools to monitor patient safety trends
Act as a liaison between Medical Safety, Medical Affairs, Clinical Operations, Regulatory Affairs, R&D, Quality, Legal and IT to ensure seamless data flow
Provide training and guidance on data governance best practices
Establish processes for continuous improvement of data governance practices
Develop KPIs and metrics to measure data quality and governance effectiveness
Lead audits and compliance checks related to data governance
Support strategic initiatives for global harmonization of safety data standards

Qualification

Data GovernanceClinical Data ManagementRegulatory ComplianceData AnalyticsCross-Functional LeadershipStakeholder ManagementCommunication SkillsCritical ThinkingStrategic ThinkingLeadership

Required

Bachelor's, Master's or PhD degree in Life Sciences or related field
Experience in data governance, clinical data management, or pharmacovigilance
Strong understanding of regulatory requirements for clinical and post-market data
Expertise in integrating diverse data sources and leveraging analytics for safety and regulatory decision-making
Strong track record of cross-functional leadership and collaboration
Excellent communication and stakeholder management skills

Preferred

Familiarity with Johnson & Johnson Quality Management Systems and Medical Safety processes
Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree, such as MBChB
Knowledge of data analytics tools and platforms. (Data Science)
Experience with regulatory compliance, data governance, and the development of frameworks and guidance to ensure data integrity and patient safety

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Company

Johnson & Johnson

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At Johnson & Johnson, we believe health is everything.

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)

Funding

Current Stage
Late Stage

Leadership Team

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Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
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Joaquin Duato
Chairman of the Board and Chief Executive Officer
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Company data provided by crunchbase