Specialist, Early Development Risk Management

작업 내용

Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Specialist, Early Development Risk Management within our BioResearch Quality & Compliance (BRQC) organization! 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. Are you interested in joining a team that is positively impacting patients’ lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity! The Specialist will support the Early Development phase of clinical research. They are responsible for working with 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, they support 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: Actively participates in pre-study activities, positively supporting the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies. Collaborates with Risk Owners to support regular review of risk areas to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs for their assigned trials. Communicates risk updates through cross-functional trial-level meetings and/or Quality Working Groups and Governance Fora, as applicable. Identifies potential systemic and/or significant quality issues (SQI) per corporate standards and communicates these to senior R&D management. 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 and Audit) Supports ongoing inspection readiness activities 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 inspections with Regulatory Compliance teams. Guides on questions related to research quality from Business Partners alongside other Quality Professionals to ensure consistent interpretation of international regulations and policy. Positively participates in working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions. Qualifications Education: Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Science, Medical, or related field preferred Experience and Skills: Required: Minimum 4 years of relevant work experience Work experience within the healthcare industry (pharmaceutical industry, contract research organization, and/or healthcare/hospital system) Proficiency in Microsoft Office Applications Experience collaborating in a cross-functional team environment with flexibility to respond to changing business needs Preferred: Good Clinical Practice (GCP) quality and/or related global clinical trial experience Experience applying the principles of risk management Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance) Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP), ICH guidelines Proven ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures Health Authority Inspection experience (FDA, EMA, and other inspectorates) Experience and/or proficiency with data analytics and/or data visualization tools (e.g., Tableau, Spotfire, or equivalent) Other: Requires English proficiency (speaking and writing), with excellent interpersonal, oral, and written communication skills Requires up to 10% domestic and/or international travel At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-New Jersey-Raritan-920 US Highway 202 Other Locations United States-Pennsylvania-Wayne, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206018788W