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Manager Oncology Risk Management

3 weeks ago

Singapore Johnson & Johnson Full time

Janssen Research & Development, LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for a **_Manager, Oncology Risk Management _**. This position will be based in Spring House, Pennsylvania. Considerations may be given for remote work.

The MANAGER (Oncology 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.

**Duties & Responsibilities**

Risk Management with mínimal direction from the Director, Oncology Risk Management:

- Actively participates 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.
- Leads 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 IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews
- Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews
- Communicates and facilitates risk updates to R&D Business Partners 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 risk to BRQC QP&S management.

**Issue Consultation, Issue Escalation, and Compliance Assessment**:

- 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 senior R&D management.
- Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities
- In collaboration with partners in BRQC, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)

**Submission Support: Pre-submission Quality Stage Gate Review (SGR)**
- Leads the Cross-Functional Trial Team and other key contributors in SGR content development & follow-up Activities
- Coaches and mentors other team members on SGR for coordination and management of activities

**Inspection Readiness and Support**
- Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
- Provides front and back room support for Sponsor-Monitor inspections at J&J sites, including post inspection support. Provide inspection support per contractual agreement for third party inspections (vendors, co-development partners, and contract research organizations.
- Provides remote support for investigational site inspections, including post-inspection support.
- Provides supervision and/or coaching for others on inspection support and readiness.

**Consultancy**
- Provides independent 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.

**Post-licensing and Acquisition (L&A) / Integration**

With the guidance from the QP&S L&A Team and 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 execute assigned responsibilities per plan.
- Provide general guidance to stakeholders
- As required, provide input into Quality Agreements with (Co-)development Partners and execute responsibilities per agreement.
- Supports and facilitates asset divestment

**Other Duties**
- Participates in QP&S, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions **_(as a team member or workstream/project lead). _**:

- Works with limited supervision, independently making decisions for compounds and studies
- Provides training and coaching to peers and new employees, as needed

**Qualifications**:
Janssen Research & Development, LLC., a member of Johnson &