- Merck & Co. (Rahway, NJ)
- …second shift openings available#MSJR#eligibleforERP#PSCSRequired Skills:Biopharmaceutical Manufacturing, CNC Operations , Computer Literacy, Data Analysis, FDA ... Job DescriptionPOCS - Rahway: Technician, Operations (FLEx Sterile Filling Technician)-Level: O3Job Family: Manuf/OperationsSenior Technician,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Principal Scientist with expertise in microbial process development for the ... biomolecules, including novel biotherapeutics, vaccines, and engineered enzymes.As a senior scientific leader, the successful candidate will shape strategy, drive… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in ... through launch and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Risk Management will be responsible… more
- Eisai, Inc (Nutley, NJ)
- … regulatory developments and assess their impact on business operations . Collaborate with Government Affairs colleagues to proactively address public policy ... If this is your profile, we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic, business-minded, and hands-on attorney role whose job will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide...managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity… more
- Merck & Co. (Rahway, NJ)
- …and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Support ... and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical… more
- Formation Bio (New York, NY)
- …will work closely with our business development, legal, clinical, CMC, and data /engineering teams to on-board products with strong IP potential, and thereafter ... coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect...and labeling-related IP issues Oversee trademark, trade secret, and data exclusivity strategies Advise on IP issues to multidisciplinary… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Senior Oncology Account Manager (OAM) for the Pittsburgh territory builds and maintains strong ... in-person engagements, aligning with customer communication preferences.Analyze key market data points and convert insights into actionable business plans.Build and… more
- Insmed Incorporated (NJ)
- … Regulatory , Compliance, Medical Affairs, Market Access, and Commercial Operations team members to align and compliantly execute key tactical activitiesWork ... future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our...participate and represent Brand in various cross-functional meetings (ie. Data Governance, Supply, Global Brand Strategy Team etc)Build a… more
- Insmed Incorporated (NJ)
- …efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents Clinical Operations in a range ... lead over an 1-2 indications within one compound, in collaboration with the Senior Director, Clinical Operations . Ensures consistent and successful execution of… more
- Insmed Incorporated (NJ)
- …and present metrics and reports on MRC activities and performance for senior leadership.Monitor and analyze operational performance data to identify trends ... in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing the operational execution of the company's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … more
- Insmed Incorporated (NJ)
- …governance frameworks and control structures consistent with NIST and FDA data protection standards.Partner with Legal, Compliance, Clinical Operations , Quality ... we do. We are seeking an experienced leader to oversee cybersecurity operations , enterprise risk management, and Computer Systems Validation (CSV) program. This role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide...managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity… more
- Insmed Incorporated (NJ)
- …us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Global Data Enablement, Corporate & Commercial Reporting, you'll ... that Salesforce Marketing Cloud (SFMC) supports compliant, effective, and data -driven customer engagement across brands and regions.The ideal candidate combines… more
- Formation Bio (New York, NY)
- …and communication skills, with a history of effectively collaborating with senior scientific, medical, and operations staff. Demonstrated ability to ... implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deliverables according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with ... of feasibility analysis to manage study implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure… more
- USAA (Charlotte, NC)
- …us special and impactful. The Opportunity As a dedicated Business Risk and Controls Advisor Senior , you will be positioned in the first line of defense to ensure the ... of risk and compliance management programs, risk analytics and operations in the business. This role will partner and...risk and compliance remediation, internal and external audits and regulatory exams, and monitoring of the first line of… more
- Genmab (NJ)
- …selection, patient recruitment forecasting, and operational risk analysis.Serve as a senior strategic partner to Development Operations (DevOps), Clinical ... strategies.Shape feasibility approaches and standards by incorporating internal and external data sources, novel technologies, and evolving regulatory and… more
