- 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
- 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)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... 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
- Merck & Co. (Rahway, NJ)
- …DescriptionThe GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global ... effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with leadership across the… 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, ... submissions, as appropriate, and corresponding therapeutic dossiers.Interacting with global regulatory authorities and diagnostic partners to determine… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical ... edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset… 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 ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… 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
- 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...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… 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 ... around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical, life sciences and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device and/or AI algorithms ... diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! -...stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory , Legal etc. as well as… 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
- 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)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... as Pharm Tech SC and biologics, Corporate Business Management)Partner and collaborate with global marketing, global medical affairs , global payers… 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
- Merck & Co. (North Wales, PA)
- …Leaders; and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical standardsCommercial lead in driving engaging presence of ... Vaccines Franchise brands at Congresses; identifying strategic congresses for Global support, including key regional congresses, aligning team activities, and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director will lead the execution and lifecycle management of Global Medical Affairs ' externally sponsored clinical research (ESR) initiatives, ensuring ... 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)
- …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
