- Aequor (Piscataway, NJ)
- …technologies. Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems. Demonstrated ... principles and change control processes. Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory … more
- Merck & Co. (Rahway, NJ)
- …of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc.Support the Quality Program Lead on ... Assurance Tools, Quality Auditing, Quality Control Management , Quality Management Systems (QMS), Quality Standards, Regulatory Requirements, Root Cause… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …more complex disease areas. This position requires experience in continuous improvement, project management , change management , and risk management . ... around rare diseases and immune disorders. Summar y : The Manager, Data Management is accountable for end-to-end delivery of clinical data management services… more
- Merck & Co. (Rahway, NJ)
- …development through process tech transfer, scale-up activities, quality investigations, change management , and authoring GMP standard operating procedures ... processing, equipment, and sterile technique.Experience in leading quality investigations and change management .Familiarity with United States and European Union… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... and cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are...the right on a temporary or indefinite basis to change or adjust job requirements to meet business, scheduling… more
- Merck & Co. (Rahway, NJ)
- …goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and inspection preparedness for the respective MA inspections in alignment with regulatory and company strategy. Act as management representative for all ... RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory AffairsLeadership/ team management :Create a high performing team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … change agent to promote flexibility, creativity, and accountability.Project management skills, responsiveness to issues, and demonstrated passion for creating ... Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …platform changes/improvements in a global manufacturing network and drive change management process from inception through regulatory approval to global site ... and deliver a process platform is robust and consistent. Portfolio management is required to implement process improvements, optimization, capacity expansion, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and ... trial monitoring and execution through RBQM activities. Accountable for the management , performance, and development, both technical and career, of direct reports,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …calibrations, instrumentation, automation PLCs, VFDs and electrical practicesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg ... availablePerforms work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Knowledge, and Skills:cGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg ... to: support to manufacturing equipment projects, cost-improvement initiatives, asset management , reliability, and business operations.Support facility project initiatives as… more
- Lundbeck (Queens, NY)
- …on customer needs and organizational goals, incorporating "total office" account management where applicable. Local Market & Therapeutic Area Expertise - Gather ... resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies… more
- SMBC (Jersey City, NJ)
- …SMBC offers a competitive portfolio of benefits to its employees. **Role Description** The Regulatory Change Management Officer works with the Regulatory ... related to overseeing timely implementation for SMBC. **Role Objectives** The Regulatory Change Management Officer role works with departments across SMBC… more
- Mizuho Corporate Bank (New York, NY)
- … examinations, reviews, continuous monitoring, inquiries, horizon scanning for emerging regulations, regulatory change management , maintenance of the laws, ... SummaryThe Regulatory Affairs Group is seeking a Vice President of Regulatory Change Management who will lead the horizon scanning process to identify… more
- TD Bank (New York, NY)
- …as a specialist on internal or external committees as well as on enterprise-wide Regulatory Change Management initiative, as required + Delivers relevant ... of enthusiastic colleagues dedicated to setting new industry standards. The Compliance Regulatory Change Office (CRCO) supports TD business lines in identifying,… more
- JPMorgan Chase (Jersey City, NJ)
- …to provide regulatory advisory capability and lead the standardization of the regulatory change management processes within Payments. As an Executive ... trends + Significant experience in providing regulatory advisory services + Regulatory Change Management skills with the ability to lead and facilitate … more
- Deloitte (Morristown, NJ)
- …with clients and among Deloitte practitioners + Experience with business transformation, regulatory remediation or change management initiatives as a ... sponsorship may be available Preferred Qualifications + Experience with business transformation, regulatory remediation or change management initiatives as a… more
- American Express (New York, NY)
- …testing and monitoring, training, reporting, complaints management , governance, and regulatory change management . + Knowledge of control theory ... colleagues and co-source resources in geographically diverse locations. + Validate management 's corrective action plans to address regulatory remediations, audit… more
- City National Bank (New York, NY)
- …to mitigate compliance risk. Additionally, the role will be responsible for maintaining regulatory change management , policies and procedures, training. This ... Degree or equivalent * Minimum 10+ years of lending and regulatory reporting in a data management environment * Minimum 10 years of management experience… more
