- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …who are strategic and bold thinkers, passionate and dedicated to driving change in Rare Disease, patient focused, strong collaborators, and inclusive leaders, as ... (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs, Compliance and other relevant NNI departments to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …who are strategic and bold thinkers, passionate and dedicated to driving change in Rare Disease, patient focused, strong collaborators, and inclusive leaders, as ... and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch Office,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …who are strategic and bold thinkers, passionate and dedicated to driving change in Rare Disease, patient focused, strong collaborators, and inclusive leaders, as ... Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Scientists as needed for exploration, experimentation, or new development Project & Change Management Experienced in managing multiple teams and workstreams with ... fast-paced environments with a focus on quality and documentation Skilled in change management and guiding teams through transitions Communication &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and communication channels related to the NovoCare® Patient Support Programs. Management of relevant data sets include compliance and database information integrity, ... stakeholders on reporting requirements, report delivery and overall performance management Optimization, visualization, and automation of program performance, both… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams through transitions.Excellent communication and ... but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights… 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
