- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized ... solutions to the world.Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … business leaders with updates regarding same (including Legal Affairs Department colleagues). Works independently and, as appropriate, in collaboration with ... to, areas of GPO/PBM and trade/distribution agreements, Medicare, Medicaid, product pricing, and government price reporting. Coordination with, and appropriate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Marketing leadership to oversee and execute all aspects of field-based programs, product theaters, & national broadcasts in conjunction with the Brand teams. This ... in pharmaceutical brand marketing, pharmaceutical industry, legal, compliance and regulatory , convention industry to provide recommendations, anticipate issues and… more
- Merck & Co. (Rahway, NJ)
- …multiple internal stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory , Legal etc. as well as external partners (diagnostic ... diagnostic products with digital pathology enabled decision support tools New product concepts and building business cases for commercialization Demonstrated… more
- Merck & Co. (Rahway, NJ)
- …including research and development, medical affairs , regulatory affairs , manufacturing, Health Economics Outcomes Research, Business Development & ... Company's commercial point of view on alliance global brand team, joint product development team, and joint regulatory / labeling discussionsSupport alliance… more
- Eisai, Inc (Nutley, NJ)
- …(s) and execution of HEOR and RWE research for the development and communication of product value data to support Eisai business . This role primarily focuses on ... products, interfaces with cross-functional teams including marketing, market access, and medical affairs to align strategies, and partners with HEOR field team in… more
- Merck & Co. (Rahway, NJ)
- …Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical challenges, provide scientifically ... stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools. - Validate and… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Novo Nordisk Inc. (New York, NY)
- 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical challenges, provide scientifically ... in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools....then your employment may pose an undue burden to business operations, in which case you may not be… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …plans and provides important input into key business decisions. Regulatory assessments and recommendations influence the product portfolio plans, scientific ... **Job Description Summary** The Director, Regulatory Affairs , Specimen Management reports directly...partner to the businesses with close alignment between the regulatory strategies and tactics and the business … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …plans to support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external contractors (eg, ... on real-world evidence, and creating hope for all facing illness. The Senior Director, Regulatory Affairs - Clinical (Neuroderm), may be called upon to guide a… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory ... develops initial product labeling and assesses proposed product claim proposal (pre-NDA). + Interfaces with Business...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Mondelez International (East Hanover, NJ)
- …may contact ### for assistance. **Job Type** Regular Scientific Affairs & Regulatory Affairs Product Quality, Safety and Compliance At Mondelēz ... In this role, you will analyze and evaluate scientific affairs issues and advocate for our business ...and provide guidance to business teams and product development on appropriate regulatory compliance and… more
- Merck (Rahway, NJ)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... **Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:** +...Associate Vice President, Therapeutic Area Lead. + Develops worldwide product regulatory strategy to optimize label and… more
