Specialist Oncology Risk Management - Beerse, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Beerse, België

3 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

_About the Johnson & Johnson - Janssen _:
Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity.

Janssen, one of the Pharmaceutical Companies of J&J, with more than 35,000 employees working hard to treat, cure, stop and prevent some of the most devastating and complex diseases of our time - from autoimmune diseases, hematology, oncology, HIV, mental disorders, heart disease and diabetes.

We believe that challenging something is the best way to change it.

So, every day, in more than 150 countries, we bring together ground-breaking science and the most creative minds in the industry to think differently about how diseases are treated and prevented.

We seek not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

We are Janssen. We collaborate with the world for the health of everyone in it.

We are recruiting for a
Specialist Oncology Risk Management .

Position Summary
With (close) supervision from the DIRECTOR, Oncology Risk Management:

The
Specialist Oncology Risk Management works with the 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, the SPECIALIST supports the execution of 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.

Major Duties & Responsibilities

_Risk Management _

Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/setup and advising clinical team members on effective mitigation strategies
Supports 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
Communicates risk updates to R&D Business Partners as part of the regular review cycle through crossfunctional triallevel meetings and/or Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned)
Highlight new potential systemic risk to R&D Quality, Clinical risk Management leadership

_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 R&D Quality, 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)

Supports SGR content development & followup activities

Inspection Readiness and Support

Supports ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection data (including, preinspection visit support), ensures availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams
Provides back room support for Sponsor-Monitor inspections at J&J Sites, including postinspection support. Provide inspection support per contractual agreement for third party inspections (vendors, codevelopment partners, and contract research organizations)
Provides remote support for investigational site inspections including postinspection support

Consultancy

Supports guidance 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 __(where applicable) _**With the guidance from the R&D Quality 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
Support the processes and roles involved in asset divestment

Other Duties
Participates in Clinical Risk Management, cross-R&D Quality Jan