Specialist Oncology Risk Management

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: Quality Job Sub Function: Clinical Quality Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: The Specialist, Clinical Risk Management, works with the trial teams to coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well – being, or rights. Throughout the duration of the trial, the Specialist executes data-driven, risk-based trial oversight activities to deliver quality in the execution of trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies  Participates in regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned)  Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations   Communicates and facilitates risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).  Highlight new potential systemic risks to RDQ CRM management  Develops and ensures a consistent interpretation of issues that require quality investigations   Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to R&D management.   Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities  In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)  Supports proactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensures availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.  Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support Provides advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.

A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is