- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Policy activities focused on the USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory intelligence and policy ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...of leading Regulatory Intelligence, this role will lead the development and implementation of a global… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader of the GRT ( Global Regulatory Team)The primary point of contact ... diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects....or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
- Merck & Co. (Rahway, NJ)
- …review and final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and ... to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize label and obtain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound,...escalate study issues /risk mitigations to the Operations Program Lead and study team leader .Ensure adherence to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … education, and process development projects, as requiredMay serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For Phase 2 ... 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. (Rahway, NJ)
- …Coordinate & facilitate upskilling to embed critical capabilities (to support the PPS director conduit from HHDDA) on behalf of Global Oncology dept. (ie-L3, ... submissions, timelines, development of deliverables for markets-- Partner closely with Global Tumor/Brand teams to assimilate L3 Next outputs to identify strategic… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... regulatory , and compliance standards. Collaborating with business and EIT...Privacy standards through continual risk and security assessment.Collaborates with global stakeholders from EIT and leaders across regions in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QA Training and Documentation management team. This position will take direction from global strategy and operational QA leader , however is also accountable to ... to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA… more
- Merck & Co. (Rahway, NJ)
- …drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the ... SAP Platform Team is responsible for our company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business...the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... 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)
- …development, including a communication cascade plan in conjunction with Director of Commercial Operations (DCO)Contracting point(s).Collaborate with brand teams to ... understand priorities and synergies with commercial engagement.- Lead the development of resources through the promotional approval process; requires collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Merck & Co. (Rahway, NJ)
- … requirements- Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that ... and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the...Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is… more
