- Merck & Co. (Rahway, NJ)
- …ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and ... or CRDRequires strong understanding of local regulatory environment. Strong scientific and clinical research knowledge is required. Strong understanding of … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... study plan including critical path activities and interdependencies for assigned clinical study (-ies) utilizing Microsoft Project or equivalent.Lead the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …integrated product development plan. This position may independently manage a lower complexity or regional project or be partnered with a more senior project ... Project Responsibilities: Independently manage and drive strategy development on Global Project Teams (GPT) for moderately complex or regional projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in a medical ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all phases of studies and participates in KOL and regulatory interactions at a project level, and interacts with regional and global project team ... studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase 2/3 clinical … more
- Eisai, Inc (NJ)
- …will oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical ... Pop PK-PD analyses,Participates in KOL and regulatory interactions at project level, interacts with regional and global...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study results as Clinical Study Leader, medical monitor or regional clinical /Translational Medicine and Clinical Pharmacology representative.External ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as… more
- Merck & Co. (North Wales, PA)
- … project management skills Preferred experience and skills: Deep clinical expertise in Rheumatology, Dermatology and Gastroenterology; building early phase plans ... and decision makers. This is a headquarters-based position in Our Company Research Laboratories Global Medical and Scientific Affairs ( Research & Development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary Responsible for leading ... Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease of review of… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Merck & Co. (Rahway, NJ)
- …deliverables.Negotiate and prioritize resource assignments with staff and stakeholders at a regional or global level ensuring that project plans are executed ... Job DescriptionResponsibilities:Responsible for both people and project management and is accountable to set strategy for the delivery of high quality and compliant… more
- Merck & Co. (Rahway, NJ)
- …and after.The candidate will work closely with value and Implementation teams under clinical development -to ensure all clinical trials include the appropriate ... design input needed for successful reimbursement and ensure alignment across Clinical , as well as with Commercial teams on pricing & reimbursement strategies,… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate ... solutions. The role involves establishing strong working relationships with the Regional and Local Access leads; alliance partners; and strong collaborations with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across the ADC portfolio plus emerging pipeline assets to advance our research and development. This role will lead workstreams with highly matrixed cross-functional ... and cross- regional teams. Stakeholders include many functions within R&D and,...disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the… more
- Merck & Co. (Rahway, NJ)
- …medical affairs as the SME in dermatology to collaborate and consult on research projects, including market support studies, clinical trials, grant programs, and ... Animal Health as a scientific speaker and veterinary professional expert at regional and national meetings by communicating key scientific and veterinary business… more
