- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... (from an accredited college or university)Bachelor's Degree (preferred in Life Sciences ) with relevant clinical development experience required Experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilitiesSummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the development and ... Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending best… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... Qualifications (from an accredited college or university)- Bachelor's Degree in Life Sciences , Pharmacy or Medicines required or- Master's Degree or other advanced… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Preferred1 or more years of experience in a leadership role within Data Science in a Global Life Sciences organizationDemonstrated experience in the ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulations and company SOPs regarding safety reporting from both post-marketing and clinical trial sources for all Novo Nordisk Inc (NNI) US marketed products… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas...cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT,… more
