- Eisai, Inc (Nutley, NJ)
- …define, implement and ensure (govern) appropriate controls.Develop strategies to manage compliance risk across IT portfolio.Communicate with IT business ... and protection. Risk Assessment: Create and periodically assess a global IT compliance risk framework.Control Gaps: Identify and manage IT compliance … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in staff meetings and other business meetings and forums.As a member of the Global Risk Management Team as well the Global Compliance and Risk Management ... of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise...rare diseases and immune disorders. Summary The Head of Risk Management US provides leadership to ensure the optimal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …of the functions that support the business including the following: Technology , Manufacturing Operations, Finance, Regulatory, Quality, Compliance , Supply Chain ... filing and launch strategy, long-range demand vs capacity planning, integrated risk management, cost of goods projections, and post-approval product/ process/ supply… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the development of functional strategies for the area of responsibility Leverages Technology Principles, Knowledge, And Practices: Ensures compliance with NN ... for products and systems within the Digital, Patient Solutions, Marketing Technology , and other relevant functional areas, driving the business IT strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …specifically GLP/GCLP studies.Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …provided need to be safe and effective using current and innovative technology . This position is responsible for the design and implementation of manufacturing ... of good engineering practice (GEP) industry standards, science and risk -based verification requirements and is required to supply support/technical knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to develop and implement security solutions and capabilities through application of risk management methods to information technology in order to manage ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Genmab (Plainsboro, NJ)
- …will report directly to the VP and Global Head of Information Security and IT Risk & Compliance , playing a strategic role in the Information Security Leadership ... ComplianceSecurity Officers in other Genmab locations (US, DK, NL)Colleagues within Security, Risk , and Compliance team, in particular security architects and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service… more
- Merck & Co. (Rahway, NJ)
- …expected to independently execute on the following:Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations under ... a matrix/management environmentLead the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity on… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also ... well as advancing a culture of scientific excellence and compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics… more
- Novo Nordisk Inc. (WA)
- …rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for all monitoring and site management activities. Takes ownership ... changing environment, supporting a future-focused approach, leveraging competencies, tools and technology . Relationships Reports to a Manager (or above) within NACD.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... colleagues to implement continuous improvement opportunities, review issues log, develop risk mitigations strategies and ensure all systems are operating well as… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology . Our science and technology make us unique, but it ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... and continued process verification (CPV)Recognize and act on potential compliance issues and opportunities for process changes/improvement.Provide technical expertise… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and expense tracking Implement best practices for billing guidelines and compliance as well as internal controls Review and draft/update policies, procedures, ... variance analysis for legal expenditures Provide insights into financial trends, risk assessment, and resource allocation to optimize financial outcomes Project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …best practices. It is responsible for research and implementation of a risk -based purchasing channel strategy anchored in category strategies. It identifies and ... drives optimal strategies that balance risk and agility in the contracting and ordering processes....stakeholders and senior management within Finance, Legal, IT, Quality, Compliance and Product Safety. Leads an Operations team comprising… more
- Merck & Co. (North Wales, PA)
- …including assessment of the probability of regulatory success together with risk mitigation measures.Lead the development, communication, and review of the CMC ... with partner groups in critical review of submissions to ensure compliance , scientific excellence, accuracy and completeness of submissions.Resolve complex project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... capability by helping to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business… more
