- Eisai, Inc (Nutley, NJ)
- …of staff. Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... cycle management of existing products. May serve as the lead regulatory representative on the project team...Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Director , Global Sourcing (Direct Materials) as part of the Technical ... Operations team based in Raritan, NJ.Role OverviewThe Director , Global Sourcing (Direct Materials) is responsible for leading the design and execution of a… more
- Eisai, Inc (Nutley, NJ)
- …reports, education, and needs.Essential Functions Advance Medical and Scientific Knowledge of the Global Medical Team (45%) Lead Global MSL continuing ... profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and...to supplement MSL development.Collaborate with Digital Strategy & Innovation lead on global MSL insights sharing forums.… more
- Merck & Co. (Durham, NC)
- …Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.-- Director Global Engineering Services Construction and Logistics ... improve standard work based on learningsTrack industry trends and lead improvementsMonitor Quality Control and Assurance programsDevelop site logistics plans… more
- Merck & Co. (San Francisco, CA)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be...policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report… more
- Merck & Co. (Rahway, NJ)
- …As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS ... every aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with cross-function teams to identify opportunities… 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...controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and… more
- Twist BioScience (South San Francisco, CA)
- Twist Bioscience is seeking a visionary and results-oriented leader to lead our global marketing efforts and drive sustainable growth. The Sr Director , ... Marketing is responsible for leading all aspects of Twist's global marketing activities. This person will plan, develop and...launching new products; and interfacing with customers. The Sr Director , Marketing also will lead growth marketing,… more
- Merck & Co. (Rahway, NJ)
- …cell bank and working cell bank) manufacturing operationsStrong understanding of regulatory requirementsAbility to lead without authority, build trust, and ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… 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 ... 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
- Eisai, Inc (Nutley, NJ)
- …management.Demonstrated track record as Study Director (or equivalent role) with Global Clinical Lead or Clinical Program Director accountability. Proven ... profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the...Development resides within the Oncology at Eisai. This Executive Director will lead franchise programs, and will… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical...the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and ... and innovative commercial work streams for a highly visible AD brand.Job Summary: Director , HCP Marketing, Alzheimer's Disease will lead several core marketing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… more
- Twist BioScience (South San Francisco, CA)
- …are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization ... processes, and align with our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software… more
- Merck & Co. (Rahway, NJ)
- …in the laboratories, and for always maintaining a state of inspection readiness.- The Director should be well engaged with regulatory and industry trends and ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The...technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate… 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 ... will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Partnerships and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch ... organization, Clinical Development, Research & Early Development, other affiliates, and the Global HQ teams. We are looking for highly motivated individuals who are… more
