- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Merck & Co. (Rahway, NJ)
- …Oncology medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Senior/Executive Director /AVP in ensuring… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of ... areas centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex ... areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Clinical Director will manage the entire ... and joint internal/external research project teams relevant to the development of new compoundsThe Clinical Director...relevant to the development of new compoundsThe Clinical Director may:Supervise the activities of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development , Research Development , Regulatory Affairs. Facilitate ... areas centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and ... external development project meetings. Conduct completeness, scientific accuracy, and ease...governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... the development and maintenance of the CCDS, US and EU...PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& ManagementOversight of Data Request processing by Service ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and ... 8.0.x and 7.0.x Patches.Experience with SQL programming/querying, custom report design/ development from Argus Safety backend database.Strong knowledge of Oracle… more
- Merck & Co. (Rahway, NJ)
- …- The Senior Director will manage the entire cycle of clinical development , including study design, placement, monitoring, analysis, regulatory reporting, ... and publication. - Specifically, the Senior Director may be responsible for Evaluating pre- clinical ...and translational work for the purpose of generating early clinical development plan and Investigational new drug… more
- Merck & Co. (Rahway, NJ)
- …clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity, ... Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... development process & connectivity between functions supporting pipeline (ie clinical development , Compound Management Coordination , supply chain, & human… more
