ONCOLOGY RISK MANAGER

Janssen Reseach and Development LLC is recruiting for an Oncology Risk Manager, located in Spring House, PA, Beerse, Belgium, Madrid, Spain, Issy Les Moulineaux, France, High Wycome, Great Britain, Malvern, PA, Wayne, PA, Somerville, NJ, Horsham, PA, Raritan, NJ or Titusville, NJ!

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/.

The MANAGER (ONC Risk Management) works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well – being, or rights.

Throughout the duration of the trial/program, this MANAGER executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

Key Responsibilities:

• Development and management of Integrated Quality Plans (IQPs)


• Work with risk and mitigation owners to control risks identified in the IQP


• Provide input into compound and trial strategies to ensure risks are identified and mitigated early


• Lead Quality Working Group meetings (QWGs) to define and refine the IQP


• Lead the escalation of and resolution of significant quality issues


• Lead inspection readiness activities, manage site inspections and assist in the facilitation of Sponsor Monitor inspections


• Act as CRM single point of contact for cross-functional and clinical trial teams and provide support on GCP/quality issues


• Conduct quality reviews of documents, as required


• Conduct ad hoc quality checks of trial TMFs


• As required, support the quality integration of post-licensing and acquisition assets