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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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Assessing regulatory requirements for regulatory capital and compliance issues in the banking industry (FRTB, CCAR, ICAAP, PRA, Volker, Basel III etc.) A career in Capital Management, within Financial Services Advisory Risk & Regulatory, will allow you to advise financial institutions on continuing to enhance their stress testing capabilities and responding to regulatory feedback.
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The Human Research Education Manager works within the CRRO (under the Office of Human Research Affairs) as well within the BU Clinical and Translational Science Institute (CTSI) Regulatory and Workforce Development Programs and helps to ensure activities support the BU CTSI's mission and goals.
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In partnership with drug discovery medicinal chemists, biologists, pharmacologists and toxicologists, you will be responsible for leading a small team of DMPK scientists supporting multiple projects from target identification through to candidate selection and ultimately regulatory submission.
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Collaborate with Legal and Compliance teams to interpret regulatory guidance and assess the impact of regulatory changes on IT asset management practices, ensuring timely implementation of necessary controls and processes.
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Lead statistical programming activities for regulatory submissions following CDISC standards. Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
$189,000 - $201,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Knowledge of regulatory requirements and compliance standards related to procurement activities within the offshore wind sector. Or add your expertise to our supply and trading operations, brokering renewable electricity, green gas, commodities, and CO2 emission allowances from one of our advanced energy trading floors.
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Under the direction of the Director of Appeals and Grievances, this clinician will ensure clinical/pharmacy appeal cases reviews meet contractual, regulatory and business goals. Maintain compliance with all regulatory and NCQA requirements with regards to this important work.
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Design and implement a framework and process for IT risk management including information security, regulatory compliance, and operational continuity risks. Experience in the life sciences industries is preferred, including working knowledge of relevant regulatory requirements and compliance practices.
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Additionally, the Program Manager monitors related regulatory updates and industry best practices; drafts and updates AWP PAM policies, procedures and guidelines; and coordinates training and education on AWP PAM policies.
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The Assistant Executive Director also initiates and implements policies that direct the daily licensing and regulatory activities of administrative and licensing staff to ensure compliance with agency policy and relevant state and federal regulations and statutes as directed by the Executive Director.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF, and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF, and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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Certified Regulatory Compliance Manager (CRCM) or equivalent certification (preferred)The base pay range represents the anticipated low and high end of the pay range for this position. About the Role:We are seeking a highly experienced and skilled Regulatory Compliance Manager 3.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Certified Anti-Money Laundering Specialist (CAMS), Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM), or Certified Fraud Examiner (CFE.
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regulatory job Title: regulatory affairs manager Company: Johnson in Cambridge, MA
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