- Merck & Co. (Rahway, NJ)
- …and lifecycle management . This individual will oversee device risk management activities to ensure the delivery of high- quality products and efficient ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is a crucial...experience in pharmaceutical development, device development, device systems operations, quality management , or a related area.Strong knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintain strategic integrated GOMA Franchise project plans, project timelines, high quality risk management plans, and communication plans, as ... and immune disorders. Summary The Global Oncology Medical Affairs (GOMA) Director , Program Management & Operational Excellence provides strategic planning… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & ... Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide...understanding of Good Manufacturing Practices, Good Documentation Practices ( Quality Data Portal ); and project management … more
- Merck & Co. (Rahway, NJ)
- …manufacturing and 10 years overall within biopharmaceuticals.Planning and facilitating high risk and highly complex Quality -related process reviews and/or ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Implement and use efficient project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere ... around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides...reports, study data protection, operational metrics, and clinical trial quality and risk management reporting… 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 ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement strategies ... for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for the Quality Management System deployed throughout the company. The Quality Director will oversee the health of the manufacturing processes through ... audits and management review. In addition, the Quality Director will represent the company as...21 CFR part 4, and all associated regulatory requirements.Drive risk management in design, validation, and ongoing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality ,… 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 ... This position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk ... planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management . Drives and leads...DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …with dependable interpersonal and communication skillsAnalytical and problem-solving skillsProject/time management skills which deliver on time and quality ... Job DescriptionReporting to a Technology Director in Global Engineering Solutions (GES), the Associate...the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication, planning and management of schedule, budget, scope, issue risk management , and quality /outcomes. Communication: Ensure that assigned ... initiative is on track and adheres to the strategic goals. Issue and Risk management and reporting: Ensure that assigned PMs identify and manage issues and risks… more
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... submission strategy for the compound. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing… more
