- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in ... Data Management Operations for the Data Validation and... protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to… 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...approaches to data review in conjunction with Data Management and Clinical Science, audit trail… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, ... Director , Clinical Development Join a Legacy of Innovation...sections of study-level documents (eg, protocol, amendments) of safety data to mitigate risk to trial participants… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assignment and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities within ... Manager, Clinical Data Repository Administration is a member of the Biostatistics and Data Management Data Operations team and serves both as a subject… more
- Merck & Co. (Rahway, NJ)
- …journey to become the premier " Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of ... cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product...risk management , and roadmap planning for data product evolutionEnsure implementation of Agile principles and best… more
- Merck & Co. (Rahway, NJ)
- …experience with ERP systems (eg, SAP), demand planning tools, and inventory management systems. - Familiarity with data analytics/visualization software . - ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Merck & Co. (Rahway, NJ)
- …at company facilities across the globe.Audit safety records and prepare supporting data for required government, industry and management reports. Required ... Safety Center of Excellence (CoE) team as an Associate Director , Safety Programs CoE.- This individual will be responsible...Programs CoE.- This individual will be responsible for the management of a portfolio of corporate safety programs that… more
- Merck & Co. (Rahway, NJ)
- …is focused on delivering exceptional performance in value creation, supplier management , and risk mitigation through strategic sourcing initiatives for ... and employing rigorous sourcing methodologies to ensure effective cost management .The CSS group encompasses the following areas:HR Services: HR Operations,… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... ensure effective implementation and cross-functional engagement. Position Description: The Director of Commercial Strategy will support strategy development for… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Genmab (Plainsboro, NJ)
- …and ongoing oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and protection policies.Works ... Role.The Director , Privacy Technologist & Third-Party Privacy Risk reporting into the Head of Global Data...team to establish third-party oversight strategy and support ongoing management of third-party data privacy and protection… 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, ... and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop… 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, ... and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ensuring ... and implement corrective and preventive actions (CAPAs) effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Formation Bio (New York, NY)
- …including specification development, manufacturing, product release, stability programs, change management , and vendor oversight. The Sr. Director ensures ... and implement corrective and preventive actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Staff members of the Medical Promotional Review team report to the Director . Works with stakeholders throughout NNI and at external agencies. Key internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA and brand activities. Secure global funding and assess progress during pre-launch Risk Management : Proactively raises risks within the brand/launch plan to ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...Are you ready to experiment with us? 5 Associate Director - Launch Excellence positions open in the following… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working with… more
