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About the Role

The Real World Evidence (RWE) Lead is a key member of the Evidence Generation Centre (EGC) Operations team, supporting and coordinating the operational delivery of assigned evidence generation activities across the study lifecycle. This role collaborates with Medical Affairs and Market Access partners to support the execution of Integrated Evidence Generation Plans by coordinating study planning, operational activities, timelines, documentation, cross-functional inputs, and vendor/partner follow-up. The role also contributes to the implementation of innovative study approaches and supports the application of AI-enabled and data-driven methodologies.

Responsibilities

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.
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.
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.
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.
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.

Requirements

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.

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

Location

Toronto, Ontario, Canada

Work Type

Full-time

Experience Level

At least 2 years

Education Level

Bachelor’s degree in Epidemiology, Biostatistics, Life Sciences, Pharmacy or related scientific field required. Preferably a master's degree or higher.

About the Company

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.

Equal Opportunity

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.