Real World Evidence Lead Toronto, Canada

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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 EGCs 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: Bachelors degree in Epidemiology Biostatistics Life Sciences Pharmacy or related scientific field is required. Preferably a masters 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 ( 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.

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