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Horsham

    Manager, Oncology Risk Management - Horsham, United States - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson Horsham, United States

    3 weeks ago

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    Description

    Job Description

    Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Clinical Risk Management within our Research & Development Quality (R&D Quality) organization Remote work options may be considered on a case-by-case basis and if approved by the Company.

    At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

    Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our innovative products? Apply today for this exciting opportunity

    You will support the Late Development (LD) phase of clinical research. They are responsible for working with trial teams to support and/or 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, they support data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials, compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

    Key Responsibilities:

    • Actively participate in all study activities, positively supporting the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.
    • Collaborate with Risk Owners to support regular review of risk areas to evaluate progress of mitigations and risk reduction, and to identify potential new risks or additional mitigation needs for their assigned trials.
    • Communicate risk updates through cross-functional trial-level meetings and/or Quality Working Groups and Governance Fora, as applicable.
    • Identify potential systemic and/or significant quality issues (SQI) per corporate standards and communicate these to senior R&D management.
    • Provide initial serious breach evaluation of quality issue that may require reporting to Health Authorities.
    • In collaboration with partners in R&D Quality, provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self-Identified, Inspection, and Audit).
    • Support ongoing inspection readiness activities to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinate mock inspections with Regulatory Compliance teams.
    • Provide supervision and/or coaching for others on inspection support and readiness.
    • Guide on questions related to research quality from Business Partners alongside other Quality Professionals to ensure consistent interpretation of international regulations and policy.
    • Positively participate in working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions.
    • With the guidance from the Licensing & Acquisition (L&A) Team and/ or Oncology Head or Delegate, support the coordination of the quality integration of the acquiring asset or company/partner and deliver robust documentation within the program/trial integration plans (90-day plan) and implement assigned responsibilities per plan.
    • Provide input into Quality Agreements with (Co-)development Partners and complete responsibilities per agreement.


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