- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after ... to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Merck & Co. (Rahway, NJ)
- …including global marketing, regional marketing, forecasting, market research, digital solutions, clinical , outcomes research, medical affairs , and IT. The ... successful candidate will also 'connect the dots' across HHDDA capability functions including market research, forecasting, payer insights & analytics, data science, data strategy & data solutions.Primary Responsibilities:-Portfolio analytics: Develop and… more
- Merck & Co. (Boston, MA)
- …closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects, ... has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in...manage and oversee the entire cycle of late stage clinical development from Phase 2 to Phase V, including… more
- Merck & Co. (Boston, MA)
- …closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… more
- Merck & Co. (Rahway, NJ)
- …and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of ... position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.The… more
- Taiho Oncology (FL)
- …The Sr. Manager, Medical Field is a field-facing representative of the Medical Affairs Department with a primary responsibility to engage in the exchange of ... practitioners on Taiho products and relevant disease states, and facilitation of clinical research. The Sr. Manager, Medical Field integrates clinical /scientific… more
- Eisai, Inc (Tyler, TX)
- …key scientific, clinical and research insights from KOLs to Medical Affairs .Develop, implement and present to management plans to support Medical Affairs ... (Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the...and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as a conduit… more
- Merck & Co. (New York, NY)
- Job DescriptionOur Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring ... applicable policies Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) - Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …intelligence to ensure that marketing, Sales operations, Market Access and Public Affairs , and enterprise function's clinical and business decision-making is ... methodologies to provide key insights into the biopharmaceutical landscape across clinical , commercial, and enterprise domains. This role involves applying data… more
