- Merck & Co. (Rahway, NJ)
- …the companyEducation:Bachelor's degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management ... efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL...minimum of 8 years of industry experience including a regulatory and/or compliance area and experience with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …specifically GLP/GCLP studies.Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management, Quality Assurance, Medical Affairs, Translational ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. Work with the business users… more
- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory … more
- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... the world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Executive Director / Director /Associate Director , Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), ... of PV agreements, PV plans, and SMPs.Maintains, in collaboration with the Executive Director / Director / Associate Director PV-PSM, the internal guidelines and… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills: Knowledge of Investigational drug regulatory requirementsAudit experience: safety, environmental, compliance /qualityUnderstanding ... FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing,...of growth.Familiarity with US and EU GMP and Safety compliance regulations.Desire and willingness to learn, contribute and lead… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build… more
- Merck & Co. (Rahway, NJ)
- …of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document ... disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial data… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internally and with external parties. Ensure that all employees are in compliance with all contract requirementsSupport the Associate Director Global Strategy ... Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team based… more
- VNS Health (Manhattan, NY)
- …Plans quality improvement activities and assures quality clinical and non-clinical compliance with regulatory authorities. Works under general direction. What ... of the review methodology.Performs utilization and quality assessment reviews to maintain compliance with Federal and State regulatory requirements. Identifies &… more
- Huron Consulting Group (New York, NY)
- …your future. **Position Summary** Huron is seeking an experienced Regulatory and Compliance Risk Director to join our Financial Institutions Advisory ... build robust risk management frameworks and ensure regulatory compliance . Within the Regulatory ...achievement. Our environment inspires and rewards growth As a Director , you have the unique ability to specialize in… more
- Citigroup (New York, NY)
- …proven ability to collaborate with multiple stakeholders across Markets, Independent Risk , Compliance , Finance, Operations & Technology. The candidate must ... extent required by, and in accordance with the Governance, Risk & Compliance & Manager's Control Assessment...Data Assets. + Develop senior management-ready materials for RMEC ( Risk Management Executive Committee) and Regulatory Exams… more
- Citigroup (New York, NY)
- Serves as a senior compliance risk manager for Independent Compliance Risk Management (ICRM) responsible for establishing internal strategies, policies, ... the risk governance framework. + Developing and establishing firm wide compliance risk management policies and procedures to mitigate risks. Monitors and… more
- Citigroup (New York, NY)
- …including defining the strategy and approach to remediation efforts for several regulatory commitments, focused on Risk Board Reporting. Manage processes, ... of experience leading transformation and/or organizational changes efforts related to Enterprise Risk Reporting and Data related compliance and transformation in… more
- Citigroup (New York, NY)
- …for AML matters relevant to Wealth.** **Set, develop, and implement strategic AML compliance risk management direction for the Wealth group globally including ... Global Head of AML Risk Management - Wealth reports to Citi's Chief Compliance Officer (CCO) Anti-Money Laundering (AML) / Bank Secrecy Act (BSA) and will be… more
