- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have ... and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and...and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DS Program developments. This position provides expertise within the Biostatistics and Data Management teams by having the Medical / Scientific knowledge for ... including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for...role. In addition, significant experiences in the use of data management systems (EDC, MDR, CDR), knowledge… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... impacting products from a quality perspective. Provide updates to management on MTP strategy for PV QA area and...to ensure Quality is consistently and proactively represented at program level and along the GvP modules in support… 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 ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This...collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Collaborate with Medical Director responsible for Communication Strategy and Medical Program Management on tracking and management of budget.Support Head ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to define problem statements and provide efficient solutions. required- Demonstrated project/ program management experience required- Certification in one or more ... as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg, Periodic ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… 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)
- …(ICFs), for assigned product(s)Authors or oversees the development of the Safety Management Plan for assigned product(s)Independently evaluates safety data of ... Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)Collaborates with… 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)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the ... Senior Director , GMA Oncology (Global Medical Affairs team lead for...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one or more indications; Interacts ... strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol… more
- Merck & Co. (Rahway, NJ)
- …concepts and solutions considering competitive factors, market demand, risk management , program economics, strategic fit, and operational complexity.Identify ... Job DescriptionThe US CA Veterinary Insights and Medical Affairs Director sets the strategic vision for the development, refinement, and implementation of veterinary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical ... perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior… more
- Merck & Co. (Rahway, NJ)
- …technology evaluation and shaping scientific strategy both at the platform and program level.Project management and/or scientific over-sight of work outsourced ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning). Maintaining… more
- Merck & Co. (Rahway, NJ)
- …Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …and variables that will influence the long-term success of a businessExecution / Program Management Skills:- Advanced project planning and management ... Job DescriptionThe Learning Director in Global Animal Health Learning & Development...metrics and measurement strategies.- Ability to analyze and interpret data for business and learning decisionsLeadership/ Management :… more
