Senior Specialist, Clinical Risk Management - Neuroscience - Horsham Pennsylvania

Company: Disability Solutions
Location: Horsham, Pennsylvania
Posted On: 04/14/2024

Janssen Research & Development, LLC, a member of the Johnson & Johnson family of companies, is recruiting for a Senior Specialist, Clinical Risk Management - Neuroscience . The preferred and primary location is Horsham, PA. Consideration may be given for candidates to be located at our Janssen R&D offices in Raritan, NJ, Titusville, NJ, Beerse, BE, Allschwil, CH, or Leiden, NL. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming 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. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. 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/. The Senior Specialist works with the trial teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well - being, or rights. Throughout the duration of the trial/program, this Senior Specialist executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness. Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! Key Responsibilities:

• 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
• Actively identifies and raises new central risk concerns to management to support collaboration and efficiencies
• 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.
• Provides guidance for significant quality issues (SQI) per corporate standards and brings up to senior R&D management.
• 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)
• 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 support for inspections including post inspection support for sites, sponsor and third parties (vendors, co-development partners and contract research organizations)
• 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.
• Participates in Clinical Risk Management, R&D Quality, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member). More...

      

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