- Eisai, Inc (Nutley, NJ)
- …industry preferred.Skills:Eisai Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and...issues, and risks in written and verbal format to regulatory senior leadership team and other governing… more
- Eisai, Inc. (Nutley, NJ)
- …Skills: Eisai Salary Transparency Language: The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from :272,200-357,300 ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… 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 ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Merck & Co. (Rahway, NJ)
- …your leadership, technical skills, and scientific acumen as part of a global , cross-functional team . - Job Responsibilities - Responsible for leading specific ... clinical data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... 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
- Merck & Co. (Rahway, NJ)
- …- Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/ Sr Principal Scientist in ... and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... 4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Merck & Co. (Rahway, NJ)
- …to demonstrate your advanced leadership and technical skills as part of a global , cross-functional team. You will build and coach your team in the development ... execution elements (eg operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes...and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position supports value evidence outcomes research… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a… more
- Merck & Co. (Rahway, NJ)
- …leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of ... clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of Protocol… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... MA training modules). The focus of these plans and activities will be either global , US-focused with intended use and adaptation by other regions globally, or solely… more
