Senior Specialist, Oncology Risk Management

Senior Specialist, Oncology Risk Management

Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, has an exciting new opportunity for a Senior Specialist, Risk Management, Quality Planning & Strategy (QP&S) within the BioResearch Quality & Compliance (BRQC) organization. This position will support the Oncology therapeutic area and can be located in High Wycombe, UK; Beerse, Belgium; Switzerland; Leiden, Netherlands; Chesterbrook, PA; Raritan, NJ; Titusville, NJ; or may consider other US locations.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are proactively working to create a world without disease. Redefining 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.

TheSenior Specialist, Oncology Risk Managementworks with the trial teams to 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 Senior Specialist, Oncology Risk Managementexecutes data-driven, risk-based trial oversight activities to deliver quality in the execution of trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

Role & Responsibilities

Risk Management:

• Actively participates in pre-study activities, positively contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.
• Undertakes 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 Integrated Quality Plan (IQP) risk monitoring information in a quality risk repository to facilitate regular progress reviews
• Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations
• Communicates risk updates to R&D Business Partners as part of the regular review cycle through cross-functional trial-level meetings and/or Quality Working Groups and Governance Fora, as applicable. Highlights new potential systemic risk to management.

Issue Identification, Escalation and Non-Compliance Reporting to Health Authorities

• In collaboration with trial teams, identifies protocol deviations and GCP non-compliance issues that may require a quality investigation to be initiated.
• Identifies potential systemic and/or significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.
• Coordinate the collection of information to support timely and adequate reporting to Health Authorities per regulation such as Serious Breaches regulations (initial and Follow-up).
• 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

• Supports Pre-submission Quality Stage Gate Review (SGR) content development & follow-up 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 (including, pre-inspection visit support), ensure 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 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.

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

• Supports 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 implements assigned responsibilities per plan.
• Provide general guidance to stakeholders
• Provide support and guidance for 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).
• Works with supervision on complex tasks
• Provides training and coaching to peers and new employees, as needed.

Qualifications

Required Qualifications

Minimum of a BA/BSc or equivalent (scientific, medical, or related field) with a minimum of 6 years’ experience working in the healthcare industry (pharmaceutical industry, contract research organization, and/or healthcare/hospital system)

Knowledge, Skills and Abilities:

• Proficiency in Microsoft Office Applications
• Proficiency in speaking and writing English
• Excellent interpersonal, oral, and written communication skills
• GCP quality and/or clinical trials experience
• Experience collaborating in a cross-functional team environment
• Flexibility to respond to changing business needs
• Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures.
• Strong knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
• Specific Therapeutic Area experience may be required depending on the position.
• Experience with fundamentals of clinical trial risk management
• Global clinical trial experience
• Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance)
• Experience working to ICH guidelines
• Health Authority Inspection experience (FDA, EMA and other inspectorates)
• Strong Project Planning/Management skills
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)
• Proven ability to analyze & interpret collective data to provide insights to drive decision-making
• Experience in managing escalations and CAPA support/advisement

Key Working Relationships

Internal

• Trial-level: Global Trial Leads, Central Monitoring representatives, Study Responsible Physicians, Clinical Scientists, Global Data Managers, Clinical Trial Managers, Regulatory Liaison, Trial Supply Managers, other functions with BRQC and Business Partner Compliance function, Medical Writer (Frequent)
• Compound-level: Global Program Lead, Central Monitoring Lead, Molecular Responsible Physician Global Regulatory Lead, Data Delivery Leads, Project Management Organization (PMO) Lead

External

• Clinical Research Organization Quality contacts, (Co-)development Partner Quality contacts

Who We Are!

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Primary Location
United Kingdom-England-High Wycombe-
Other Locations
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Chesterbrook, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Switzerland-Aargau-Baden
Organization
Janssen Cilag Ltd. (7360)
Job Function
Quality
Requisition ID
2105993333W