- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …authority and trust Serve as the expert on social media channel performance, risk management , competitive analysis, and emerging best practices to inform ... for the better. The Position The Associate Director, Consumer Social Media Strategy is a high-impact, hands-on leadership role responsible for the development,… more
- 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)
- …improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and Strategy : Is accountable ... study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards… 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
- Sanofi (Morristown, NJ)
- …Core knowledge, competencies & skills: Digital: Advanced Leadership skills: Intermediate Risk Management skills: Intermediate Project Management skills: ... Job Title: AI-Enabled Early Operational Strategy Leader Location : Cambridge, MA Morristown, NJ...ROI. The incumbent must have strong leadership and change management skills, and a passion for delivering transformative approaches… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for Medical ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Team. Relationship Reports directly to Head of PV Case Management . This role involves the oversight of case handling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …can clearly convey the status of security and related issues surrounding enterprise risk management decisions to all levels of the organization including ... Essential Functions Support the Security Director's efforts to develop an effective strategy to assess and mitigate risk , manage crises and incidents,… more
