- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, on ... resolve or escalate study issues /risk mitigations to the Operations Program Lead and study...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, on ... resolve or escalate study issues /risk mitigations to the Operations Program Lead and study...complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study… more
- Merck & Co. (North Wales, PA)
- …execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead , you will collaborate with global, cross- functional team-members including ... trial scientific-activities.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical … 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...bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of… more
- Merck & Co. (Rahway, NJ)
- …Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the ... Operations .Collaborates internally with HQ functions, regional and local operations , EU Clinical Development, Pharmacovigilence, Global Medical Affairs to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies ... 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… more
- Merck & Co. (Rahway, NJ)
- …to the CTCs, as well as for interns-delegated to the Clinical Operations team based on the Internship program , while-properly managing situations of low ... or non-performance.The role will work across the different country operations roles (eg CRM( Clinical Research Manager), CRA( Clinical Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple program -level CS Asset Leads ... life cycle is optimized across multiple programsThe CS group lead will also contribute to the program ... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will… more
- Merck & Co. (Rahway, NJ)
- …your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device ... Job DescriptionDevice Development Principal Scientist - Device Development Lead (Director Equivalent) Our company's Device Development (DD) Team designs, develops,… 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
- Eisai, Inc (Nutley, NJ)
- …unlawful actions.Oversee system data retention standards and verify system operations .Manage Eisai's information governance program , including JSOX ... security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the… more
- Merck & Co. (Rahway, NJ)
- …(LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and ... product (LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and Operations… more
- Merck & Co. (North Wales, PA)
- …Responsibilities: -Portfolio and Project Management (~50%)Responsible for aggregating individual program information to a portfolio viewEstablish robust CMC and ... clinical stakeholder interfaces to maintain a pulse on all...tools, dashboards, and business systems.Manage cross divisional workstreams and lead or input into improvements to processes / templates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical ... cloud-based label phrase library, working collaboratively with the CSO Program Managers to identify and meet delivery dates for... Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead QC Microbiology Data ... air and surface sampling, related to Raritan manufacturing processes, either for clinical trials and commercial operations in a controlled cGMP cleanroom… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and delivers a holistic, effective process qualification program for Operations trainees who support daily clinical production and strategically prepare ... Process Trainer will be responsible for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy… more
- Merck & Co. (Boston, MA)
- …and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early ... clinical space, determining and implementing the initial ...the Common Technical Document (CTD) and label, including relevant compound/ program life-cycle management.The successful candidate will have an essential… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of External Vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers,… 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 ... the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program … more
