- Daiichi Sankyo, Inc. (Bernards, NJ)
- …epidemiological data , and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert ... the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous improvement around… more
- Merck & Co. (Rahway, NJ)
- …Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming Language), Risk Management , R Programming, Science, Scientific Literacy, Trade ... to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data ...of current and future information needs Strong commitment to compliance and ethical standards in data handling… more
- Merck & Co. (Rahway, NJ)
- …point for the docketing team, attorneys, and staffImmediately reports all risk management -related concerns to Senior LeadershipResponsible for the compilation ... checks are performed and discrepancies resolvedOversee IP docketing system to ensure data integrity, accuracy, and compliance with rules and departmental… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities in collaboration with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical database (edit checks, CCG ... file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Pharmaceutical Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, Scientific Data Management , ... quantitative systems pharmacology, model-based drug development (MBDD), or scientific data management .- Proven experience leading cross-functional teams to… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Merck & Co. (Rahway, NJ)
- …Capital Project Management , Capital Projects, Change Management , Cybersecurity Risk Management , Data Analysis, Deviation Management , Equipment ... start-up operations (FLEx) and new capital builds, including automation lifecycle management , data /analytics, and site representation on capital projects.- Some… more
- ValSource, Inc. (Rahway, NJ)
- …21 CFR Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality, ... projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data -Driven Decision Making, ... drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… 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
- Merck & Co. (Rahway, NJ)
- …Communication, Data -Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management , ... strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare… more
- Merck & Co. (Rahway, NJ)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... toCoordinate project planning, resourcing, progress reporting, troubleshooting and people management .Responsible for process development, process characterization and regulatory filing… more
- Merck & Co. (Rahway, NJ)
- …in commercialization and manufacturing in aspects of quality control, compliance , and strategic partnering. Primary Responsibilities: Reports to the Executive ... employees. Establishes a viable succession plan for key positions. Ensures cGMP compliance and operational excellence in the laboratories. Maintains a state of… more
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug… more
- Merck & Co. (Rahway, NJ)
- …Services primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityUnder ... will be expected to lead small teams of auditors audits with limited management supervision in addition to actively performing audit work.Under the direction of the… more
- Merck & Co. (Rahway, NJ)
- …the functional area; guide career development; build strong, collaborative teams.Champion compliance and safety while promoting a culture of diversity, equity, and ... (omics (transcriptomics, metabolomics, or/and proteomics), metabolic flux analysis); statistics, data -science, machine learning, artificial intelligencePRDRequired Skills: Biological Manufacturing, Biological… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAPAs, change controls and complaints.Perform analysis on quality indicating data and identifying trends.Contribute to maintain investigation compliance ... able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and capital expenditures (CapEx), ensuring alignment with business objectives, quality, compliance , and cost optimization. The role will work closely with ... goals. The Manager will play a key role in vendor management , contract negotiation, and operational procurement excellence.Key Responsibilities Support and lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an approved cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes ... functional partners.Key Responsibilities Integrate into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including… more
