- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead is responsible for the management ... of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial drugs to the sites… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety ... studies Lead activities under the direction of Clinical Safety Scientist Product Lead Develop expertise in one or more focus areas (SME) Involved in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …proactively perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team ... proactively perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and ... may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project...Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians… more
- Merck & Co. (Rahway, NJ)
- …all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact ... for multiple indications simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug ... Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and… more
- Merck & Co. (Rahway, NJ)
- …degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth ... of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations/change… more
- Merck & Co. (Rahway, NJ)
- …capabilities understanding with key business and IT partners, as well as product ownership for the technology solutions and services.This Associate Director role ... IT area to support the Market Access and Revenue Management IT product roadmap.- Business capabilities in this area include payer engagement, affordability… more
- Merck & Co. (Rahway, NJ)
- …of immediate and future state business objectives.The SAP Platform Communications Lead will play a critical role in our customer/business-centric approach. This ... in supporting our organization through a transformative journey as we adopt a product model mindset and begin our S/4 Journey.As the SAP Platform Communications … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role Overview ... The Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting...systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to ... is the GPT Leader, directly accountable for conceiving, designing and implementing product development strategy and delivery for their asset(s). The GTL has… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all Product Launch, Sales, and POA Meetings. Take the lead in "Train-the-Trainer" programs when rolling out assigned customers training programs and ... and manage vendors and/or projects that enhance disease state and/or product knowledge, and/or selling skills. Responsibilities: Product Training Development:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation and evidence generation for a successful market ... will engage the clinical, Medical Affairs and commercial organization and drive the product evidence strategies to ensure an effective use of HEOR and RWE methods.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as identified by senior management.Responsibilities- Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting US ... States (such as Global Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and support for the business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... Global Team leader as the Project Management lead on drug development projects. This position can be...strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …efficiency and decision making.Responsibilities Project ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development ... the Global Team Leader to drive strategy development and create an integrated product development plan and timelines. Ensure execution of overall plan and annual… more
