- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project management , change management , and risk management . Responsibilities Leadership, Direction, and Strategy : - In collaboration with Clinical ... Management globally and ensures execution of the data management strategy across regions. This individual is...that Data Management Plans are consistent and regulatory compliant across studies and programs.- Promotes Risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy .Represents the CSPV department as subject ... assures the quality of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... status, escalating issues in a timely manner for earliest resolution, Regulatory Inspections:Facilitates regulatory inspection preparation, management , and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identified during internal systems audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory ... processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Merck & Co. (Rahway, NJ)
- …Regulatory Compliance, Regulatory Requirements, Resource Stewardship, Results-Oriented, Risk Management {+ 5 more}Preferred Skills: Current Employees ... leader will establish and operationalize standardized processes, own data management strategy and execution readiness, and ensure...Process, Master Data Management (MDM), Project Management , Project Scheduling, Project Strategy , … more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Packaging, Risk Communications, Risk Evaluation And Mitigation Strategy (REMS), Risk Management {+ 5 more}Preferred Skills: Current ... drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and...view and solve problems to achieve results Drive proactive risk management activities, including risk … more
- Merck & Co. (Rahway, NJ)
- …and inspire accountability Ethical, resilient, and committed to excellence Skilled in risk management , team facilitation, and strategic planning Experience in ... guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of clinical development, as well as ... using quality by design principles and with focus on comprehensive life-cycle management . Mentor and supervise junior colleagues; coach, and develop talent within… more
- Merck & Co. (Rahway, NJ)
- …closely with other functional area representatives to negotiate timelines and strategy for clinical supplies. Interacts with key partner organizations such as ... clinical development, regulatory , quality and other supply chain areas to address...supply chain areas to address clinical supply and/or change management related topics. Responsible and accountable for establishing the… more
- Merck & Co. (Rahway, NJ)
- …Engineering, Packaging Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management , Root Cause ... tasks.Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.Exhibited leadership qualities such as… more
- Formation Bio (New York, NY)
- …Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best ... requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and… more
- Merck & Co. (Rahway, NJ)
- …leader to shape and drive innovation across the Biologics pipeline, strategy , and science.Anticipate and solve scientific and technical challenges across projects ... of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing… more
- Merck & Co. (Rahway, NJ)
- …participants with hands-on exposure to finance, accounting, auditing, analytics, risk management , and special projects.Throughout the program, individuals ... Management Controls, Microsoft Excel, Preparation of Financial Reports, Procurement, Reputational Risk , Stakeholder Management , Treasury Management {+ 1… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.Experience with Healthy Authority requirements and ... implementation in cGMP production environment. The individual will be responsible for management and delivery of the integrated project and program plans, ensuring… more
- HSBC (New York, NY)
- …high expectations and is likely to come under scrutiny as part of any major regulatory investigation. Management of Risk + Ensure all actions take account ... Regulatory Compliance Brand: HSBC Area of Interest: Risk and Compliance Location: New York, NY, US, 10001...framework. The Director of Wealth, Private Banking and Insurance Regulatory Compliance for US is the management … more
- HSBC (New York, NY)
- …Americas Finance Leadership Team, senior management in Global Finance, Enterprise Risk Management , Internal Audit, External Auditors and regulators + Have ... NFRs include, but are not limited to, Financial Reporting Risk , Regulatory Reporting Risk , Model...Americas Finance Leadership Team + Manage a team of risk management experts across multiple locations and… more
- RGP (New York, NY)
- …firm or a strategy consulting firm (required). + Extensive experience in risk management , regulatory compliance, and digital technology within the ... forward thinking. + Lead and manage client engagements focused on risk management , regulatory compliance, and audit remediation across banking, insurance,… more
- SMBC (New York, NY)
- …a highly skilled and customer-focused data analyst with strong visualization and project management capabilities. The Strategy and PMO Project Support member is ... a part of the Cash Management group within Corporate Banking. This role will drive...in a structured fact-based manner, including plans, assessment of risk and alternatives and proposed paths to resolution. +… more
- SMBC (New York, NY)
- …internal audit professionals. - Effectively communicate with stakeholder and audit senior management to clearly articulate audit strategy , testing results and ... Audit Department. The Audit Manager will report to the Risk Stripe Lead and be responsible to design and.../ capital markets products. - Advanced understanding of applicable regulatory standards / guidance for a Bank Holding Company… more
- Terumo Medical Corporation (Somerset, NJ)
- …(CEP, LRP, LRR, CER). + Contribute to Hazard/Harm list creation as a part of Risk Management per product. + Research, create, and edit assigned clinical reports, ... and writing Clinical Evaluation Plans and Reports for submission to regulatory bodies, and various activities including abstracts and manuscripts in alignment… more
