Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Medical Affairs GroupJob Sub Function:
Medical Affairs – Marketed ProductsJob Category:
People LeaderAll Job Posting Locations:
Toronto, Ontario, CanadaJob Description:
Johnson & Johnson Innovative Medicines is recruiting for a Real World Evidence (RWE) Lead to be based in Toronto, Canada.
About the Evidence Generation Centre (EGC)
The Evidence Generation Centre (EGC) is a focused centre of excellence within Johnson & Johnson Innovative Medicine Canada. It is responsible for managing the end-to-end Integrated Evidence Generation planning process, building Real-World Evidence (RWE) capabilities, and operationalizing non-interventional studies across therapeutic areas./
The EGC’s core mandate is to enable high-quality, efficient execution of non-interventional studies and to advance innovative approaches to RWE; leveraging novel study designs, real-world data assets, and emerging capabilities such as advanced analytics and AI to generate impactful evidence for decision-making.
Role Overview
Reporting to the Manager of RWE Operations, the RWE Lead is a key member of the EGC Operations team, supporting and coordinating the operational delivery of assigned evidence generation activities across the study lifecycle.
In close collaboration with Medical Affairs and Market Access partners, the RWE Lead supports the execution of Integrated Evidence Generation Plans by coordinating study planning, operational activities, timelines, documentation, cross-functional inputs, and vendor/partner follow-up to help meet quality, regulatory, timeline, and budget expectations.
This role also contributes to the implementation of innovative study approaches and supports the application of AI-enabled and data-driven methodologies to improve study feasibility, execution, and insights generation where appropriate.
Key Responsibilities
Study & Project Management
Coordinate operational delivery of assigned non-interventional studies across the study lifecycle from start-up to close-out
Track study timelines, budgets, resources, vendor activities, and deliverables, escalating issues as appropriate
Support development and maintenance of project plans aligned with SOPs, ICH/GCP, and regulatory requirements
Identify study risks and support mitigation planning, escalating risks and decisions as appropriate
Study Start-Up & Execution
Support study start-up activities, including coordination of approvals, protocol development, vendor/data partner onboarding, contracting, and kick-off
Coordinate execution activities, including vendor/partner follow-up, data quality tracking, and adherence to timelines and quality standards
Ensure proper documentation, filing, and archiving in accordance with regulatory and company requirements during study close out
Stakeholder & Vendor Management
Serve as a key operational point of contact for assigned studies across internal functions and external partners
Coordinate SMEs and external partners to support study execution and timely input
Facilitate study meetings and support timely documentation and follow-up on action items
Track vendor performance, flag quality issues, and support follow-up on deliverables and milestone payments
Evidence Generation Strategy & Innovation
Support implementation of assigned activities within Integrated Evidence Generation Plans across therapeutic areas
Contribute operational input to RWD methods and study design discussions that meet stakeholder needs
Support the application of AI, advanced analytics, and new data sources to enhance study feasibility, execution, and insights generation where appropriate
Support publication planning and post-hoc analyses of real-world datasets where relevant
Governance, Compliance & Reporting
Support compliance with regulatory, quality, and company requirements for assigned studies
Act as an operational point of contact for assigned local studies, including coordination of safety reporting requirements
Maintain study systems and documentation in collaboration with the Manager of RWE Operations and relevant study partners
Provide regular updates on study progress, risks, and performance metrics to support timely decision-making
Core Capabilities & Qualifications
Education: Bachelor’s degree in Epidemiology, Biostatistics, Life Sciences, Pharmacy or related scientific field is required. Preferably a master's degree or higher.
At least 2 years of proven clinical project management experience in evidence generation RWE required
Strong knowledge of clinical research, non-interventional studies, and ICH/GCP guidelines
Highly organized with the ability to manage multiple priorities
Strong stakeholder engagement and influencing skills
High attention to detail and commitment to quality and compliance
Excellent written and verbal communication skills
Fluency in English required, additional fluency in French is an asset
Experience working with the pharmaceutical industry considered an asset
Experience working within J&J current therapeutic areas considered an asset
As guided by Our Credo (https://www.jnj.com/our-credo) Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Data Savvy, Developing Others, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Mentorship, People Performance Management, Product Development Lifecycle, Program Management, Scientific Communications