- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Degree preferredExperience Qualifications7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or ... Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label...Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational… more
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with...packaging processesAct as the Quality partner to support the Supply Chain and Operations department. Act as site subject… more
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... Supervisor. The Pre-Distribution Supervisor is responsible for distribution supervision of clinical supplies . This is a full-time position: Monday - Friday,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... within the Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and interdependencies for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical ... level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and current awareness of the evolving global requirements for diversity in clinical trials -Continually evaluate industry landscape and lead identification ... clinical operations experience in trial diversity and patient access and/or clinical operations project management preferably with a sponsor company at a… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …one or more key functions (eg clinical research & development, clinical science, clinical quality assurance, project management) Preferred requiredStrong ... 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. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project ;...meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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 ... research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...likely to benefit from our therapeutics. Contributes to CDx project teams for the diagnostic, under the direction of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL)- Clinical Surveillance: Documents ... ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of … more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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 ... end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
