- Merck & Co. (North Wales, PA)
- Job DescriptionActing as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with ... Quality and Continuous Improvement (QCI), Global Clinical Trial Operations (GCTO), and Global Clinical ...and others.Ensures compliance and alignment with GCD model and regional and local regulations.Collaborates with GCD roles to evaluate… more
- Merck & Co. (Rahway, NJ)
- …models a plusDomain knowledge in pharmaceutical business areas such as research , clinical , manufacturing, commercial and corporate functions highly ... Job Description Job title: AI Research Scientist -Opportunity to be a part of...of a global Artificial Intelligence team!Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study results as Clinical Study Leader, medical monitor or regional clinical /Translational Medicine and Clinical Pharmacology representativeExternal ... 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
- 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 The Clinical ... leads company operational activities to comply with US, EU, Japan and other regional disclosure regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member… 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)
- …(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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for planning, managing, and coordinating projects within DSI CSPV and global clinical safety and epidemiology function. Deliver the project according to ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position is… 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)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The purpose of ... oncology franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE...key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the… more
- Eisai, Inc (Nutley, NJ)
- …planning, development, deployment, and support in multiple domains (such as research , clinical , finance, human resources, manufacturing, sales, marketing). ... 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)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position serves ... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads… more
- Merck & Co. (North Wales, PA)
- …processes) including experience including bringing materials through legal, regulatory, and clinical review Strong project management skills as demonstrated by ... interface with internal and external stakeholders, including US Medical Affairs, Regional Vaccine Medical Directors, Global Marketing, the Center for Observational… more
- Eisai, Inc (Nutley, NJ)
- …disease.Drug development experience, preferably in AD, and thorough understanding of clinical research methodology is preferred.Must understand and adhere to ... required.Demonstrated track record and authorship of peer-reviewed publications in AD research ; Experience with authorship of publication and project management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research , Research , Informatics Services Project ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Deliver the… 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
- Aequor (Thousand Oaks, CA)
- …support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully ... Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data...offers the opportunity to be at the interface between research , global development and manufacturing to ensure that our… 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
- 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
- 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
