- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and ... demands significant skills in working in fast-paced environment, continuous improvement, project management , change management , and risk management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(LPPC), Graphic Designers, Marketing and Supply Chain. Relationships Reports to labeling management in Regulatory Operations (RO), engaging with key company ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting , SPL Blanket No Change Certification, FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the relevant support teams for their domain area. This includes managing service contracts, change management , and SLA management . The GSM partners with ... champion the day-to-day operation of the lifecycle of Incident, Problem, and Change Management .Communicate and interface with matrix teams, IT leadership,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across various operational areas Help with post-acquisition integration and management of financial records of newly acquired entities Proactively identify, ... for compliance with the current and new GAAP or International Financial Reporting Standards (IFRS). Coordinates US response and recommendation for implementation to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …via a future focused approach, leveraging competencies, tools and technology, and with change management skills. Ensures business needs are met through alignment ... skills in designing and implementing innovation/improvement initiatives, including the required change management Strong analytical and problem-solving skills -… more
- Genmab (NJ)
- … reporting in clinical trialsExperience and understanding of GCPs, SOPs, regulatory requirements and good data management practicesExperience working on early ... futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment… more
- Aequor (Libertyville, IL)
- …11, and good documentation practices.Knowledge and experience in utilizing Change Management Applications ie ServiceNow, Infinity, Veeva, Valgenesis.Experience ... candidate will be primarily responsible for managing IT deviations, CAPAs, Investigations, Change Management , and computer system validation in support of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a future focused approach, leveraging competencies, tools and technology, and with change management skills. Relationships Reports into NACD Therapy Area Head. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...team collaboration, training and development, employee engagement, and recognition Change Management : Identifying areas for improvement in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …skills in designing and implementing innovation/improvement initiatives, including the required change management We commit to an inclusive recruitment process ... Are you ready to make a difference? The Position Reporting to the head of Clinical, medical, Regulatory...(SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, project management , change management , and risk management ... this position possesses working knowledge of medical terminology capture and reporting of safety data, pharmacovigilance, industry best practices, and relevant … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access and Public Affairs (MAPA), Portfolio Strategy, Commercial Excellence, Regulatory Affairs, and other relevant NNI departments to ensure alignment of ... Define key performance metrics and establish mechanisms for tracking and reporting on the effectiveness of Rare Bleeding marketing strategies and initiatives… more
- Genmab (Plainsboro, NJ)
- …futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment ... to fulfilling our purpose.The Role.The Director, Privacy Technologist & Third-Party Privacy Risk reporting into the Head of Global Data Privacy Program, will serve a… more
- Merck & Co. (Durham, NC)
- …uring equipment, facilities and utilities. Preferred Experience and Skills: Prior Change Control and Deviations Management experience GMP quality experience ... product, drug substance, media preparation, and sterile supply.Position Responsibilities: Reporting to the Quality Assurance Organization, will independently manage… more
- Twist BioScience (South San Francisco, CA)
- …and execute roadmapsProvide guidance, assessment, and oversight on the governance of Change Management and System Access Controls and provide recommendations on ... Sarbanes-Oxley (SOX) compliance program, ensuring all internal controls over financial reporting (ICFR) are designed, implemented, and maintained to meet … more
- Novo Nordisk Inc. (Durham, NC)
- …experience required LEAN manufacturing experience and training required General knowledge of change control systems and Quality Management Systems (QMS) required ... and processes for our operations areas to meet business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Qualifications, and Supplier Requalification's Maintain Supplier NDAs and Quality Agreements Management and reporting of metrics related to applicable Supplier ... products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job Responsibilities Oversee… more
- Novo Nordisk Inc. (Virginia, WA)
- …with key stakeholders. Future-looking leader with superior ability to lead through change . Relationships Internally, the Educator Manager (EM) reports to a Region ... diabetes and obesity care (eg, diabetes centres of excellence, quality, care management , population health, and other key departments focused on improving diabetes… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports on test performance, including success rates, failures, run, and delay timesChange Management : Participate in change management processes to ensure ... to work in a fast-paced GMP environment.Key Responsibilities Testing Scheduling Management : Configure, monitor, and maintain job scheduling systems (eg Smart QC,… more
- Fidelity Investments (Boston, MA)
- …to ERP/GL SaaS implementations, Alt Investments and/or Digital Assets incl. regulatory guidanceFamiliarity and proven record of driving change within ... assurance reviewsAdvanced understanding of US GAAP, Internal Controls over Financial Reporting , and COSO frameworkBlend of Public Accounting and Internal Audit… more
- Ochsner Health System (Marrero, LA)
- …in indicators of operational success such as unit productivity, expense management , regulatory requirements, and quality indicators. Proficiency in using ... or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion. Education Required - Registered nurse diploma.… more
