Johnson & Johnson · 1 week ago
Associate Director Regulatory RWE & EPI
New Brunswick, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$137K/yr - $236K/yr
5+ years expJohnson & Johnson is a leader in healthcare innovation, committed to improving global health through advanced medical solutions. The Associate Director Regulatory RWE & EPI will lead efforts in utilizing real-world evidence for regulatory submissions and approvals of medical technologies, collaborating with various teams to ensure effective project execution.
Hospital & Health Care
Responsibilities
Work in close collaboration with colleagues and business partners to develop protocol-driven studies in the areas of cardiovascular, surgery, and methods development, evaluating safety, effectiveness, benefit-risk assessment, and utilization patterns of medical devices manufactured by J&J MedTech in these areas. Other areas of RWE work may include predictive analytics and quantifying the burden of diseases and surgical complications
Develop, review, and write study protocols and statistical analysis plans (SAP)
Lead and oversee the analysis; execute and/or review codes for analyses; and work with analysts to extract raw data from servers, create analytical data files, and execute statistical analyses based on protocol specifications
Develop, review, and write study reports for regulatory submissions for marketing authorization approvals (label expansions and initial approvals) by the US FDA, as well as regulatory authorities in the EU, Asia Pacific and Latin America
Conduct feasibility assessments of medical device studies using in-house real-world data resources, including electronic medical records, administrative healthcare claims databases, hospital billing data, or registries and clinical coding taxonomies such as the International Classification of Diseases (ICD), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) and evaluate the relevance and reliability of real-world data sources
Lead or contribute to the design and data analysis of RWE studies including comparative studies, the creation of external controls for single-arm trials, adjusted indirect comparisons, covariate balancing, and outcome analyses, as well as systematic reviews and meta-analyses
Lead or contribute to projects to evaluate disease natural history, treatment patterns, patient journeys, safety and effectiveness of medical devices using clinical and surrogate endpoints, or benefit-risk questions for specific devices
Manage research projects and timelines
Disseminate scientific information through technical reports, presentations, and publications in peer-reviewed literature, as agreed by the team
Develop, review, and write RWE study manuscripts and conference abstracts and presentations
Present research to internal stakeholders or external audiences
Lead the evaluation, identification and cataloging of real-world data assets to answer novel research questions
Evaluate linked datasets to improve the relevance and reliability of real-world data sources to address important research questions for regulatory submissions
Collaborate with partners within J&J and work closely with colleagues from MD Epi-RWDS and larger cross-sector epidemiology
Lead or participate in work streams / task forces to standardize research and analytical processes to improve efficiency and quality of deliverables
Participate in discussions with the FDA and other regulatory authorities regarding RWE studies such as Q-submissions, and address the comments on RWE study protocols and reports
Qualification
Required
A PhD in Biostatistics, Statistics, Epidemiology, or related fields or an MD with a masters in Biostatistics, Statistics, Epidemiology, or related fields
At least 5 years of experience of RWE and Epidemiology related research work in the pharmaceutical or medical device industry, consulting, or healthcare organizations
In-depth knowledge of the structure and caveats of electronic medical records, claims, and/or hospital billing databases
At least 5 years of hands-on experience working with electronic medical records, claims databases, and/or hospital billing data databases and clinical coding taxonomies such as the International Classification of Diseases (ICD), Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), including the development of the codelists for medical events
At least 5 years of experience in writing study protocols and statistical analysis plans for RWE studies of medical products
Strong knowledge and expertise in epidemiologic and statistical concepts such as confounding, bias, cumulative incidence, incidence rate, regression models, survival analyses
At least 5 years of experience conducting comparative safety and effectiveness outcomes evaluations using propensity score methods
At least 5 years of hands-on experience in statistical programming in R or SAS and database programming in SQL or Python using large healthcare databases
At least 5 years of experience authoring peer-reviewed publications (abstracts, posters, and manuscripts) using real world datasets
Hands-on experience with the target trial emulation method including statistical programming is a plus
Agility to work in a fast paced, changing environment
Strong written and verbal communication skills
Strong teamwork skills and ability to collaborate well with team members
This position may require up to 10% of domestic and international travel
Preferred
Experience in machine learning and AI programming and modeling using large healthcare databases for research work experience
Advanced Analytics
Clinical Operations
Cross-Functional Collaboration
Data Privacy Standards
Developing Others
Disease Management
Emergency Planning
Environmental Health
Epidemiology
Financial Competence
Inclusive Leadership
Industry Analysis
Leadership
Public Health
Public Health Surveillance
Researching
Team Management
Vendor Management
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
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 StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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