- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Director , Clinical Operations/CPMSun Pharma Advanced Research Company, Limited SummaryThe Director , Clinical Operations/CPM is responsible for the development of ... for required deliverables.Oversee maintenance and timely update of Trial Master File (TMF/eTMF) & Study folder and timely tracking...& study plans and other reports ie Protocol Deviations, Data entry & SDV status, Query status etc. and… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey SummaryThe Associate Director , Clinical Operations is ... responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as...required deliverables. Oversee maintenance and timely update of Trial Master File (TMF/eTMF) & Study folder and timely tracking… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential? ... support the organization's long-term aspirations. Relationships Reports directly to the Sr. Director , Planning, Execution & Operations, with a strong dotted line to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement clinical ... programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD functions to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is responsible for the ... management and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to create submission plans that result in high… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to both technical and non-technical stakeholders. Preferred:Hands-on experience with Veeva CRM and master data management tools preferredExperience with big ... or more years of IT experience, with a focus on digital analytics, data management , or related roles supporting the pharmaceutical industry.4 or more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is ... responsible for the management of technology transfer of the manufacturing processes of...transfer, site-to-site technology transfers and PPQ as needed. Conduct data review and analysis, data -driven decision-making process,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a ... in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to Medical ... MA staff in other functions to drive consistent interpretation of our scientific data and establish a consistent, unified medical voice/position across MA- Lead new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders ... reconciliation as necessary. Operational Efficiency / Continuous Improvement:Provides leadership within Data Management related to medical coding topics by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc. - Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST...a science or in a technical field preferred - Master 's Degree preferred Experience Qualifications - 10 or More… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population...Phase 3 registrational study(ies); Develop prospective contingency plans for management of key risks in a large study or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST and DSE to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR ... but not limited to, service agreements, research partnerships, sponsorships, memberships, data sharing, non-disclosure, and master service agreements across a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Legal to ensure successful pull through of corrective action plans and/or performance management Manages ER data in order to identify, measure, and analyze ... Position The Manager, Employee Relations role ensures consistent and thorough management of Employee Relations processes, including performance management .… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … stewardship and governance processes, data cataloging data standards, data quality, and data management .- Develop and implement strategies for ... data governance program, data stewardship program or similar intent data management program focused on setting standards, policies, and guidelines for… more
