- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for...role such as a Global Project Leader at Sr. Director level or equivalent preferred- Relevant therapeutic experience and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …limited to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will also serve as the ... in one or several programs.Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations , Data Management, Scientific Operations etc) and ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years relevant experience is required with a BSc required.Experience in clinical operations methods and processes in industry setting required.Experience ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Daiichi Sankyo, Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs and labelling.- ... areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's ... communicates internal compliance metrics within Daiichi Sankyo.Member of Global Clinical Trial Disclosure Function and Operations Committee.Act as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... and Regulatory Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally- Creates a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders. Provides ... research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etcQualifications: Successful ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...your employment may pose an undue burden to business operations , in which case you may not be offered… more
