Senior Specialist Immunology Risk Management

Key Skills

Data science techniques, Effective communication skills, Google Cloud Platform (GCP), Immunology, Leadership Skill, Management, Tableau, US Healthcare Recruitment

Job Description

With direction from the Associate Director, Therapeutic Area (TA) Risk Management:

The Senior Specialist works 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 executes 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.

Key Responsibilities:

Risk management:

• Actively participates in 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

• Participates in 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

• Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations

• Facilitates 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 Forum, as applicable (trial and/or compound, as assigned)

• Actively identifies and escalates new central risk concerns to management to support collaboration and efficiencies

• Highlight new potential systemic risk to R&D QUALITY Clinical Risk Management (CRM)

• 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 & follow-up Activities

• Inspection Readiness and Preparedness Support

• Supports proactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection 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 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 (where applicable):

• 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

• Provide support and guidance for asset divestment

Other Duties

• Participates in CRM, cross-RDQ 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).

QUALIFICATIONS

Education:

A minimum of a Bachelor's or equivalent University degree is required, with a focus in Scientific, medical, or related discipline preferred.

Required:

• 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.

Preferred:

• 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, preferably in a global setting
• 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
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)
• Experience with Regulatory knowledge and understanding of Investigational Medical Diagnostics

Other:

• This position may require up to 10% of domestic & international travel

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.