- 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
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… 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)
- …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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …the company's strategy; this includes a deeper knowledge of internal controls, business compliance , and risk management. Individuals will be based in the global ... develop a breadth of experience including finance, accounting, analytics, risk management, and special project opportunities.Corporate Audit and Assurance Services… 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
- MultiPlan (New York, NY)
- …REPORTS TO: The Chief Information Security Officer (CISO) JOB SUMMARY: The Director of Information Security - Identity and Access Management (IAM) provides ... skills, and the ability to drive cross-functional strategic initiatives while ensuring compliance and security best practices. JOB ROLES AND RESPONSIBILITIES: The … 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Excellence for Scenario Planning and Modeling. The Advisory is led by a director and structured to act as a hub, bringing together cross-functional teams such as ... of our strategic direction. Relationships The position reports to the Director , Strategic Pricing and Contracting - Advisory. The individual will partner… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:Market & Collateral Risk Management - Director The Team Join Fidelity's Collateral & Market Risk Management team to help protect the firm ... estimate market related risks. The team develops and maintains risk models, methodologies and processes to ensure the ...of the firm's stress testing and margining processes.Partner with Compliance to draft responses to regulatory inquiry… 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
- CIBC (New York, NY)
- …areas, including Credit Risk , Regulatory Compliance , and Data Risk . The Internal Audit Director is a leadership position within the US Internal ... Policy, FP&A, Corporate Treasury, Liquidity and Capital Management, Interest Rate Risk Management, Regulatory Reporting, and Internal Controls over Financial… 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
