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New York, United States of America The Senior Director, Model Validation for Santander US Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR11-07 and other regulatory requirements around Compliance models.
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Provide training and guidance to pharmacovigilance staff and stakeholders on compliance-related topics, including adverse event reporting, signal detection, and regulatory requirements. We are seeking a highly motivated, experienced, and passionate individual to join our team as Pharmacovigilance Quality and Compliance Pharmacovigilance Coordinator at Ardelyx Inc. As a subject matter expert, you will play a pivotal role in ensuring the adherence of our pharmacovigilance activities to regulatory requirements, industry standards, company policies, and global regulations.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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Oversee quality assurance activities to ensure the integrity, accuracy, and compliance of clinical trial data within Veeva Vault applications, in accordance with regulatory requirements (e.g., FDA guidelines, GCP standards.
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As an Anti-Money Laundering (AML) Compliance Senior Manager, you will lead the AML program strategy, including reporting, advisory, and governance, to ensure industry-leading performance and compliance with all regulations.
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Lead identification of assay requirements, lab selection, and contract development to ensure regulatory compliance according to GLP, GCP, and applicable global regulatory requirements such as CLIA and EU IVDR, and execution feasibility.
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Educate Compliance and business personnel on applicable Compliance-related rules and regulations, including Investment Advisers Act of 1940, Investment Company Act of 1940, Commodity Exchange Act, ERISA rules, FINRA rules, and global regulatory requirements for investment advisers, broker dealers, mutual funds, exchange traded funds, commodity pools, hedge funds, and other products.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) and demonstrates compliance with Home Health Foundation policies and procedures. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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Familiarity with regulatory requirements and compliance in equity capital markets. This is a brand-new role for the firm, reporting to our CO-Chief Investment Officer and will offer an exciting opportunity to become a pivotal partner in shaping our equity capital markets strategy.
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Assist regulators and consultants by providing requested information necessary to conduct regulatory/compliance reviews and examinations of the funds assigned. Must have advanced knowledge of regulatory requirements and limitations, and operating policies for mutual fund service providers (i.e. investment adviser, custody, distribution, fund accounting agent, transfer agent, fund administration.
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Ensures ongoing compliance with all applicable regulatory agencies for department section (including but not limited to: CLIA, TJC, OSHA, DPH, HCFA, FDA, AABB, NCCLS). Maintains updated Policy and Procedure Manuals using the NCCLS format in compliance with regulatory agencies ensuring documentation of Supervisor and Medical Director review annually and at revision.
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The ideal candidate will have a background in OSHA and EPA regulatory compliance, environmental health & safety program development, risk identification, and compliance auditing. Assist with the implementation and continuous improvement of the Environmental, Health, and Safety programs including but not limited to emergency preparedness, fire safety, environmental compliance, hazardous and biological waste management, industrial hygiene, biosafety, occupational health, respiratory protection, ergonomics, and training.
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Ability to interpret microbiological environmental monitoring results in terms of risk assessment and regulatory compliance. Manages the DFCI Biosafety Communications Program by identifying topics relevant to investigators with biosafety protocols such as upcoming modifications to IRIS for human gene therapy clinical trials and iRIS-IBC for laboratory registrations and any regulatory and DFCI policy updates, training requirements, resources and guidance, and those requested by the Director of Biosafety.
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Familiarity with programming for data analysis; ideally Python, SQL, or R.Experience working hands-on with other cross-functional team leaders, such as lawyers, engineers, product managers, data scientists and operations teams in improving compliance processes and systems.
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Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with regulatory requirements. Provide regulatory guidance and support to internal teams to ensure compliance with regulatory obligations throughout the organization.
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regulatory compliance jobs Title: principal in Newton, MA
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