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Serve as the technical SME (subject-matter expert) and participate in the strategic development of enterprise data governance policies; ensure the Onyx data governance products adhere to industry standards and regulatory compliance, fostering a culture of data security and integrity within the organization.
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This position will partner with other members of the Compliance organization and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal.
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As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.
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Examples of Enterprise Quality engagements include but are not limited to: identifying emerging technology to support business needs to accelerate our Quality & Compliance strategy thru digital enablement; leading cross sector Quality Management System & Metrics; delivering ongoing process improvements via Supplier Quality Reliability; interpreting evolving regulatory requirements in the digital space to drive proactive solutions for J&J technology from initial implementation and sustained use.
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Anti-Money Laundering (AML) and Financial Crime platform in Compliance Systems team includes the AML/BSA systems, Transaction Monitoring system, OFAC/Sanctions systems and other tools. Assist in the data analysis and documentation processes, development, testing, implementation, validation, and maintenance of BSA/AML/OFAC models and scenarios used across the company.
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This role will also play a key role in the Privacy, Forced Labor, and Product Regulatory programs and support a range of compliance activities, such as maintaining and communicating compliance policies, updating compliance education programs, process development, implementation, and monitoring.
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The Unit Manager - RN coordinates resource utilization, timely and appropriate care interventions, and interdisciplinary communication to enhance patient and family satisfaction, adherence to center's clinical systems and regulatory compliance.
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Comprehensive understanding of ICH-GCP guidelines and international regulatory frameworks, with proven track record of applying these standards in clinical research and contractingDemonstrated success leading and directing the global supply market evaluation process using all available market intelligence, risk, compliance, and financial assessment tools.
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Participates in day-to-day implementation of Bank’s compliance with the Bank Secrecy Act (BSA), Anti-Money Laundering (AML) and Office of Foreign Assets Control (OFAC) programs. Ensures compliance with the Anti Money Laundering, Know Your Customer, OFAC/Sanctions and other regulatory requirements.
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Supports CMC regulatory compliance activities for portfolio biologics to meet US, International Conference on Harmonization (ICH), and other applicable regulations. Evaluates CMC changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation.
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Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity.
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Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety, and regulatory compliance. Ensure productivity, timeliness, and quality of investigations and CAPA implementation.
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Knowledge of budgeting, supply contracts, and shipping requirementsKnowledge of corporate compliance, ethics policies and code of conductUnderstanding of Inventory Control and Management proceduresExperience:At least five years of supervisory experience required.
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Demonstrated experience in identifying, assessing, and mitigating, regulatory and compliance risk. Ensures compliance with industry, regulatory and L’Oreal Group defined policies and standards.
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Regulatory Understanding: Understand fundamental regulatory principles pertaining to Organic, Non-GMO, Vegan-Vegetarian, Prop 65 Compliance, Natural, Allergens, Kosher, etc. Regulatory Compliance Marking: Accurately mark all raw materials in Vicinity with the relevant regulatory compliances based on information gathered from vendor documentation.
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regulatory compliance implementation jobs in Warren, NJ
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