- Merck & Co. (South San Francisco, CA)
- Job DescriptionHealth Systems Oncology Medical Affairs Director , US Medical Affairs - NorCal, NV, AZThe Health Systems Oncology Medical Affairs ... organizations.The HSO MAD provides accurate information across the full oncology product portfolio, clinical science, and quality management in...resource for the HSO MAD Team Lead, HSO Executive Director Medical Affairs , and other members of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US,...in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory … more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs .-Preferred: MS with minimum of 8 years of relevant … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in ... oncology , as well as other research areas centered around...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in ... oncology , as well as other research areas centered around...diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in ... oncology , as well as other research areas centered around...around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … 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 ... that could include Executive Director , Senior Director , or Director level personnel responsible for oncology clinical development programs or projects.… 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 ... 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)
- …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)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in ... oncology , as well as other research areas centered around...centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be… 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 ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … 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)
- …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)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
