- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans, ensuring appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT ( Global ... with direct regulatory affairs experienceExperience in regulatory submissions in OncologyManagerial experience preferredExperience with global … more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- JobsRUs (Athens, GA)
- …current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areasUnderstand and monitor ... JobsRUs.comis seeking to hire a Senior Specialist for our client in Athens,GA! Pay...and support key user responsibilities as applicable.Knowledge in relevant Regulatory Affairs areasAbility to understand and anticipate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… more
- Tris Pharma (Monmouth Junction, NJ)
- …and/or licenses or certificates requiredGCP Subject Matter ExpertThorough understanding of global and local clinical trial/study regulatory requirements and ... New Jersey, Tris has an immediate opening for a full-time permanent Director/ Senior Director, Clinical Quality Assurance. This is a hybrid position. Job Title… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director… more
- Merck & Co. (Rahway, NJ)
- …global network. -You will work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs -CMC to ensure that validated methods ... Research and Development (ARD)-at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation &… more
- Merck & Co. (Rahway, NJ)
- …sites, External Manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs , Procurement, and suppliers. Key Functions Work ... Job DescriptionWe are seeking a Growth and Improvement minded Senior Engineer in Device Technology that can help drive our Strategic Operating Priorities.Invent -… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...Compliance, and Finance. The position has high exposure to senior management and requires a highly motivated individual who… more
- Merck & Co. (Rahway, NJ)
- …interfacing with other functional areas (eg project management, manufacturing, quality, regulatory affairs ) and external partners to drive project milestones ... breakthrough science changing the way we approach animal health challenges.-The Senior Scientist within our company's Animal Health Formulation Group is responsible… more
- Merck & Co. (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (Rahway, NJ)
- …learn new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements. The ability to multi-task, work independently, ... reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs ) as well as DSI employees performing Global roles in the ... limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...United States (such as Global Marketing, Global Medical Affairs ). For these areas, acts… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior ... Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical … more
