- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director , Asset Management & Reliability, in this role as Associate Director Asset Management & Reliability CoE, you will be ... Manufacturing Operations within a designated region in the Manufacturing Division.As Associate Director of Asset Management & Reliability CoE you will play a crucial… more
- Merck & Co. (Rahway, NJ)
- …background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... 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)
- …in Small Molecule Global Science, Engineering, & Commercialization (SM GSEC) The Director , DCT Leadership position in the Manufacturing Division is a dedicated ... and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial… more
- Merck & Co. (Rahway, NJ)
- …and analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality and Regulatory Location - Remote, Preference ... Job DescriptionPosition Title - Director / Principal Scientist, Regulatory Compliance Department - Device...Director / Principal Scientist, Regulatory Compliance Department - Device Quality & Regulatory Brief Description of Position- This position… more
- Merck & Co. (Rahway, NJ)
- …Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new ... indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development ... for parenteral drug products within the small molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Office of General Counsel is seeking an Associate Director , Legal - Intellectual Property (IP) Technology & Operations to provide application ... test and provide training for database version releases and new features, manage data migration and improvement projects Apply country law updates to the IP… more
- Merck & Co. (Rahway, NJ)
- …across our Digital Manufacuring Division and IT to develop, test, and deliver high quality , scalable, and reusable data and digital products Oversee Agile Scrum ... of the contribution of such program to organizational success. Manage the quality and appropriateness of the work performed and delivers measurable business benefits… more
- Merck & Co. (Rahway, NJ)
- …is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are ... in achieving those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the ... strategic and execution perspectives for Eisai. Reporting directly to the Executive Director , IT Security, Compliance, & Architecture, s/he is the Global IT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... updated Core Data Sheets, EU and US Documentation: As the project...Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: Serve as a… more
- Tris Pharma (Monmouth Junction, NJ)
- …guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves as Deputy to ... Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory guidelinesContinuing Education:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems, incorporating relevant advancements to optimize system performance and functionality.- Data Quality , Testing and Release ManagementEstablish and enforce ... privacy.Implement processes to regularly test, audit and validate HR data to maintain high data quality...and validate HR data to maintain high data quality standards.Conduct system audits, optimize performance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training and Documentation management ... leader, however is also accountable to the VP of quality . The incumbent is expected to understand and apply...periodic alerts to teams to ensure that shared point data is current and accurate- In collaboration with Head,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality Compliance ... SME for health authority reporting (eg, FAR, BPDR, DPRs, MDRs)develop and use data analytics tools to assess compliance risk at sitessupport our company's audit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for remote/in office dedicated time. EST time-zone hours. The Position The Director , Diversity, Equity, Inclusion & Belonging (DEI&B) plays a pivotal role in ... a market leader in the DEI&B space. Relationships The Director , DEI&B reports to the VP, People, Culture &...the process and consultation associated with sharing of employee data with ET members and HRBPs for their respective… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and execution of National Advisory Board meetings, at the discretion of Executive Director ) Deliver clinical data and other presentations at National Advisory ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …helping to solve vital business needs for Finance by leveraging data analytics and understanding implications on global healthcare systems. Audit assignments ... working intimately with our global business operations.-In addition, individuals will use data analytics to gain insights into business practices and the execution… more
