- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... and reconciliation, query management, and database lock preparation/execution, in compliance with our company's Standard Operating Procedures (SOPs) and ICH-GCP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems… more
- Merck & Co. (North Wales, PA)
- …of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and ... relationships with both internal and external groups. The Associate Director Pub Manager is expected to: Lead cross-functional Publication Teams for a number… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based ... in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, ... for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.Contributes to the development of local… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including strategy, technology, and documentation. The role will be the direct manager of other positions related to eDiscovery and Data Management. Relationships ... in close collaboration with the Legal Department, IT, HR, Ethics & Compliance , and records management stakeholders, and all other relevant functional areas. The… more
- Novo Nordisk Inc. (West Palm Beach, FL)
- …coordination with key stakeholders. Future-looking leader with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) ... work is focused on those standards Ensure teams effectively identify "at risk " patient populations and utilize education and other relevant treatment guidelines to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operation, and management of the company's legal operations function and will lead strategic legal projects. The primary responsibility of the role is developing, ... close collaboration with Legal Department, IT, HR, Ethics & Compliance , and other stakeholders from across NNI. The role...across Novo Nordisk globally. The role is a people manager , responsible for direct reports and supervising work performed… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... reporting safety issues and completing corrective/preventative actionsDrive culture of compliance through actions, consistent quality-driven decision making, and coaching… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …analysis for Risk Report and investor relations document Serve as a key lead with legal & compliance on various workgroups Develops scenario impact models on ... responses, and state-level transparency initiatives. This includes proactively identifying risk , financial modeling, providing findings and key insights to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering ... on a day-to-day basis, and act as the central resource for team communication Lead project scope and deliverables definition in concert with project champion and key… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing ... and documentation of automation projects and their lifecycle management in compliance with FDA regulations. Represents the department regarding automation issues… more
- Insmed Incorporated (Bridgewater, NJ)
- …matrix organization, driving decision making, facilitating issue resolution, problem-solving, risk management, contingency planning and decision-making. Lead and ... This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the successful and… more
- Merck & Co. (Rahway, NJ)
- …to ensure the business succeeds in utilizing these capabilities and we minimize our risk of outages that can impact our operations.The engineer will also work with ... the Print Product Manager to adopt and set a vision, roadmap, manage...a global organization.IT Service Management experience - ability to lead the delivery of services, ensuring that agreed service… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process owners to demonstrate that processes are in control and ensure required compliance levels. Implement and lead the process to regularly review and ... as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business… more
- Novo Nordisk Inc. (Boulder, CO)
- …Essential Functions Manage the maintenance and implementation of safety programs, compliance plans, and initiatives with primary focus on laboratories as well ... as office and support work areas Lead the investigation of incidents, near misses and property...air ,water, waste Manage the laboratory waste disposal Perform risk assessments, job hazard analysis Develop, maintain, and implement… more
- Merck & Co. (Millsboro, DE)
- …at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the ... leadership of the Animal Services Department.Essential Duties / ResponsibilitiesAssociate Director: Lead and develop a team of animal care and testing… more
- Aequor (Framingham, MA)
- …Chemical Safety, Bloodborne Pathogens, Biosafety, Laboratory inspections, etc.) Ensuring compliance with all applicable federal, state, and local occupational health ... and permits (Occupational Safety and Health Administration and local permits). Leading risk assessment processes, including, but not limited to job hazard analyses,… more
