Associate Director Regulatory RWE & EPI

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Epidemiology

Job Category:

People Leader

All Job Posting Locations:

New Brunswick, New Jersey, United States of America

Job Description:

We are hiring an individual to join our team and grow their expertise and career in using real-world evidence (RWE) for global marketing authorization approvals (label expansions and de novo approvals) for J&J MedTech devices with the US FDA, the Chinese NMPA, the EU notified bodies, and other national regulatory agencies.

 

The preferred location for the position is New Brunswick, NJ, Titusville, NJ, Springhouse, PA, Irvine, CA and Jacksonville, FL. Other J&J locations will be considered on case to case basis.

Position Summary:

Caring for the world, one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science, bringing innovative ideas, products, and services to advance the health and well-being of people, on a global basis. We thrive on and grow with an inclusive company culture, follow the ethics-based Credo of Johnson & Johnson, and are an equal opportunity employer.

 

The MedTech Epidemiology and Real-World Data Sciences (MT Epi-RWDS) organization within Johnson & Johnson is an industry leader, on the cutting edge of conducting observational and epidemiologic research to support regulatory submissions, post-market safety and effectiveness evaluations, product development, value assessments, predictive analytics, machine learning, and business development of medical devices. Johnson and Johnson MedTech is approximately the second largest medical device company in the world (it may vary over time), with a strong focus in cardiovascular, surgery and robotic devices, and vision. The MT Epi-RWDS team is part of the Global Epidemiology Organization in the Office of the Chief Medical Officer and collaborates with the Johnson & Johnson Innovative Medicines Epidemiology group.

 

The team leads Real-World Data innovation and methodological excellence across Johnson & Johnson’s Medical Device sector and provides skills and expertise in using RWE to support label expansions, product development, safety, value demonstration for payers, and other activities. 

 

We are looking for a talented and innovative individual to join our team and grow their expertise and career in using RWE for regulatory submissions and approvals of innovative medical technology. The person will be responsible for leading or contributing to various RWE projects and evidence generation needs for J&J MedTech business units.

 

Principal Duties:

• 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 bill