Specialist, Early Development Risk Management

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

Johnson & Johnson is currently seeking a Specialist, Early Development Risk Management to join our Clinical Research Management team located in Beerse, Belgium.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-023646

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Specialist, Early Development Risk Management, reports to the Director, Early Development Clinical Risk Management. The Specialist Early Development Risk Manager 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.

Key Responsibilities :

With supervision from the Director, ED Risk Management:

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.
• 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 (SPECIALIST only), as assigned).
• Maintains CQP (Clinical 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 cross-functional trial-level meetings and/or Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
Highlight new potential systemic risk to RDQ CRM management.

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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 RDQ, 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)

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, 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.

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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

• With guidance from the L&A team, 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 include: Participates in CRM, cross-RDQ J&J IM, 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:

Required

• BA/BSc or equivalent (Scientific, medical, or related discipline)
• A minimum of 2 years (SR ASSOCIATE)/ 4 years (SPECIALIST) of experience working in the healthcare industry (pharmaceutical industry, contract research organization, and/or healthcare/hospital system) 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.
• Up to 10% domestic and international travel may be required as business demands.

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
• 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)
• 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)