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Authors, reviews, and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions. Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
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There is emphasis on proactive monitoring, governance, risk identification and escalation, as well as making sound risk decisions commensurate with the business unit's risk appetite and all risk and compliance program requirements.
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Minimum 5 years of BSA banking experience including branch/platform experience and knowledge of Bank Secrecy Act regulatory requirements; Previous experience in AML, compliance or related position preferred, or relevant course work in criminology, law, logic as well as auditing and other business courses; Leadership or management experience.
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The Regulatory & Compliance Manager will assist the Compliance Officer with implementation and ongoing development of the Company's Compliance Program to ensure adherence to regulatory requirements.
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Ensures compliance with Company and legal policies, procedures, and regulations for assigned areas by analyzing and interpreting reports, implementing and monitoring loss prevention and safety controls, overseeing safety, operational, and quality assurance reviews, developing and implementing action plans, and providing direction and guidance on executing Company programs and strategic initiatives.
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Prior Guideline Monitoring, Investment Operations, or Investment Compliance experience and/or an understanding of different regulatory regimes would be advantageous but not required.
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QUALITY - Actively participate in nursing strategic initiatives such as quality improvement and monitoring, regulatory compliance, recruitment and retention of staff and patient and employee satisfaction.
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As such, this position requires compliance with the S.A.F.E. Mortgage Licensing Act of 2008 and all related regulations. Successful candidates must also meet ongoing regulatory requirements including additional screening, if necessary.
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Interface with representatives from key functional groups (Monitoring, Data Management, Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, Legal, and European Clinical groups.
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The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
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Demonstrates knowledge of regulatory agency requirements (JCAHO, DHEC). Adheres to all compliance and policy and procedure requirements of the organization including, but not limited to: licensure renewal, assigned training, employee health screenings, time and attendance policy, dress code policy, patient confidentiality, infection control, medication administration.
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Basic knowledge of regulatory compliance of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations. The External Manufacturing Specialist coordinates all aspects of contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.
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Assist with monitoring regulatory developments and providing ad hoc compliance and legal operations support as needed. Support the Compliance Officer with day-to-day activities and monitoring of the firm’s compliance program.
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Possesses a broad and comprehensive understanding of different Internal Audit standards, policies and local regulations; applies a broad and comprehensive knowledge of high-risk areas including: Consumer or Investment Banking, technology management; project/program management; regulatory compliance or supplier management.
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regulatory compliance monitoring jobs
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