- Merck & Co. (Rahway, NJ)
- …preferred (engineering or scientific discipline, MBA)Knowledge of Global Regulatory Affairs and Clinical Safety organization, roles, and ... Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... science and technology. With more than 125 years of scientific expertise and a presence in more than 20...transparent ways of working across the Alliance within US regulatory affairs and will work closely with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across… 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 ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. --Specifically, the Director may… 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 ... analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational work for… 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...is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The… more
- Merck & Co. (Rahway, NJ)
- …partners including disease and alliance teams, research and development, medical affairs , regulatory affairs , market access, outcomes research, ... We are seeking a talented individual to join the team as Global Marketing Director to focus on expanding and growing our product, the first-and-only HIF2 inhibitor,… more
- Merck & Co. (Rahway, NJ)
- …and manage all communications across the vaccine portfolio and pipeline, including regulatory approvals, governing bodies, publications of scientific data and ... Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and… 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 Team ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting will drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... science and technology. With more than 125 years of scientific expertise and a presence in more than 20...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Merck & Co. (Rahway, NJ)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be… more
- Merck & Co. (Rahway, NJ)
- …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 May… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... diseases and immune disorders. We are currently seeking a Global Oncology Medical Affairs (GOMA) Publications Intern for summer 2025. This full time position works… more
- Merck (Rahway, NJ)
- …(engineering or scientific discipline, MBA) + Knowledge of Global Regulatory Affairs and Clinical Safety organization, roles, and responsibilities. Current ... **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory … more
