- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Degree preferredExperience Qualifications7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or ... position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This... Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also contribute to the program study ... Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or ... new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader; Responsible before the IST for the creation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be ... also accountable for supporting divisional and departmental level objectives and may also lead a non- project initiative in support of these objectives. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Merck & Co. (Rahway, NJ)
- …which enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, ... members to ensure the quality and safe delivery of clinical supplies , the scientific rigor of the...Preferred Experience and Skills: Operations experience in a GMP clinical supply facility (intermediate scale or pilot… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for planning, managing, and coordinating projects within DSI CSPV and global clinical safety and epidemiology function. Deliver the project according to ... Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Eisai, Inc (Nutley, NJ)
- …start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support , creates, and communicates ... clinical trials. Oversees and resolves operational aspects of clinical trials in conjunction with project teams...plans CRO and Vendor Contributions: Assist in managing ancillary supplies with vendor/ sites Assists COL with action Item… more
- Merck & Co. (Rahway, NJ)
- …Vaccines AR&D, Global Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply , CMC Regulatory, Quality, and Commercial-facing ... Analytical Validation team to serve as an Analytical Program- Lead . The lead must take charge in...of release, characterization, and stability assays for testing of clinical trial material and in support of product and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally… more
- Merck & Co. (Rahway, NJ)
- …well as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical ... (Pharm Ops Engineering).The FLEx facility supports the formulation and filling of clinical , stability, and developmental supplies for Oral Solid Dosage (OSD)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to ... Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …macros and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Aequor (Thousand Oaks, CA)
- …teams that include: Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply ... at Thousand Oaks, Building 20. Building 20 is a clinical and commercial syringe and vial filling facility supporting...approach. Strong project management skills, with prior project experience a must Lead meetings with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation and evidence generation...key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tools and macros and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Project lead on programming safety supports for safety signal detection, ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... areas centered around rare diseases and immune disorders. Summary The purpose of the Lead of Global Medical Affairs Oncology is to take the leadership position to… more
