- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... RA strategy into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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)
- …Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global...with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global … more
- Merck & Co. (Rahway, NJ)
- …partners including disease and alliance teams, research and development, medical affairs , regulatory affairs , market access, outcomes research, ... competitive strategy, target product profile development, health authority interactions, global regulatory filing strategy, launch readiness reviews, organized… 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 ... 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 Director … more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills:Minimum 10 years' experience in communications and corporate affairs ; healthcare and pharmaceutical experience at global publicly-traded ... Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing...is responsible for leading, developing and executing US and global communications strategies and programs that support our Company's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionTitle: Associate Principal Scientist/Associate Director , Outcomes ResearchRole SummaryUnder the guidance of a senior leader, an Associate Principal ... Scientist/Associate Director , has primary responsibility for planning/managing real world and...Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… 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 ... Job DescriptionOur company is a global health care leader with a diversified portfolio...regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to 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
- Merck & Co. (Rahway, NJ)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. We are currently seeking a Global Oncology Medical Affairs (GOMA) Publications Intern for summer 2025. This ... hours per week. Responsibilities: Daiichi Sankyo Inc's Oncology Publications team within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems… more
- Merck (Rahway, NJ)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global ... business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
