- Merck & Co. (Rahway, NJ)
- …in line with the global strategy, including but not limited to overall supplier management , compliance , risk management , diversity spend, and stakeholder ... will be required to provide primary expertise in Capital planning, engagement management and performance improvement of the capital spend, and ensure complete… more
- Merck & Co. (Rahway, NJ)
- …areas of the enterprise. Areas included, but not limited to are, overall supplier management , compliance , risk management , diversity spend, and ... directed.-In addition to providing primary expertise in Capital planning, engagement management and performance improvement the senior specialist will provide direct… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Merck & Co. (Rahway, NJ)
- …stakeholders at all levels, ensuring their commitment to the technical transfer vision. Risk Management , Compliance Oversight & Decision Making:Lead the ... rigorous technical support processes to support manufacturing sites, proactive risk management , performance monitoring, and continuous improvement.-Experience… more
- Genmab (Plainsboro, NJ)
- …policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep ... the implementation of technical rules and standards for privacy compliance in data life cycles and deployment of technologies...oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Leadership team including insights on financial performance, capital allocation, and risk management ; Directs cost monitoring and reporting activities; Drives ... In depth knowledge of corporate financial law, compliant financial reporting and risk management practices Excellent knowledge of data analysis and forecasting… more
- Genmab (Plainsboro, NJ)
- …strategy that protects our people and assets worldwide.This role will oversee security risk assessments, crisis management , and compliance with regulatory ... biotech, or related industry preferred).Expertise in:Global security operations, crisis management , and risk mitigation.Security strategy development, incident… more
- Genmab (Plainsboro, NJ)
- …and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities.Site Selection and Management Collaborate with the ... and completeness of the eTMF, supporting inspection readiness and regulatory compliance .Maintain relevant sections in Clinical Trial Management Systems and… more
- Formation Bio (New York, NY)
- …health authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory ... and implement corrective and preventive actions (CAPAs) effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, implementing ... to make a difference? The Position Drive portfolio strategy and study management activities and manage cross-functional study team, external service providers (CROs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the HHDDA Commercial Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and...sites.Introduce and implement methods to detect fraud or site non- compliance such as: different approaches to data review in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …new ideas, solutions, methods or opportunities; foster innovation through appropriate risk -taking and experimentation to ensure that the Medical Promotional Review ... product labeling committees and other department projects/initiatives Demonstrates the people management skills needed to lead direct reports and working teams;… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... and local site procedures for safety, quality, and regulatory compliance - Understand the big picture, and how activities link...to our Company strategy and business goals- Utilize device risk management tools to build device or… more
- Genmab (Plainsboro, NJ)
- …Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health ... This responsibility will involve collaboration with a partner. Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.… more
- Merck & Co. (Rahway, NJ)
- …Associate Director, Safety Programs CoE.- This individual will be responsible for the management of a portfolio of corporate safety programs that may include High ... Risk Work, Fire & Life Safety and other similar...manage company's safety standards and technical guidelines to ensure compliance and reduction in workplace safety risks.Lead global continuous… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... cross-functional understanding and to support project timelines.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... cross-functional understanding and to support project timelines.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk … more
