Johnson & Johnson Careers
SPECIALIST QP&S TRIAL OVERSIGHT
High Wycombe, United Kingdom
Requisition ID: 1805672432W
Who are Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. We are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it.
We are looking future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
You will provide trial and support for the drug application process as well as supplement applications. Working within the clinical teams from inception to review all critical aspects and risks including building checks and balances to mitigate these risks, assessing risk and putting controls and measures to minimize the impact of possible issues. You will be using monitoring standard checks and reviewing protocol such as informed consent and other key documenting in line with compliance and internal regulations. You will have responsibility for managing CAPA’s and internal reports for global submissions
- Supporting and executing (may develop and managing and maintaining) trial oversight activities for assigned trials/indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
- Support pre-study activities, giving to the review of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.
- Ensure that selection of investigator sites balances benefits against potential risks and that rationale for decisions are well documented.
- Monitors risks and mitigations during study execution. Prepares periodic reports assessing critical to quality parameters for the trial and reviews these reports with applicable team members to evaluate pre-defined as or newly identified areas of risk.
- You will assist in executing the Integrated Quality Plan (IQP), collaborating with the QP&S IQP leader, Program Leader and Trial Oversight Managers.
- Assisting in the preparation of Quality Working Group (QWG) meetings.
- Assists in the development of materials for Stage Gate Review, as needed.
- Provides ongoing compliance guidance on an ongoing basis. Liaises with QPS Program Leads / Managers and other members of BRQC, as appropriate, to ensure interpretation alignment and consistency with guidance provided.
- Supporting inspection readiness for the clinical trial, and provides support during sponsor-monitor inspections.
- Supporting critical issues of significant quality issues according to company policy and SOPs and in collaboration with the clinical team, and BRQC Peers, to ensure timely issue resolution.
Do you have the following essential skills experience and background?
- You have previous experience in Quality and Clinical (GCP)
- your experienced in or have a deep understanding about risk management
- Excellent team working skills
- Dedicated, 'can do' attitude
- You have excellent communication&S skills
- Flexibility, in order to respond to changing business needs.
- Willingness to engage, learn and share standard methodology across the team and organization
- Experience in Oncology Therapeutic area, desirable but not essential
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)