- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Director US Medical Affairs (USMA) Oncology, under the direction of the Senior ... Director , USMA Oncology (US Medical Affairs team lead for...assigned medical affairs plan activities, in collaboration with Sr. Director .- Leads medical readiness activities for market launches. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports ... projects and interacts with the DSI Case Management team / global case management team and partners on a daily and as-needed basis. Management of escalated case processing issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Lead/contribute to DS R programming system technology development: Lead/contribute to the R programming system development. Act as R programming SME and functional ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe purpose of the Senior Director , Forecasting & Business Analytics is to lead the forecasting and financial ... and analytical support of commercial assets. In addition, this role will lead the forecasting process supporting the Business Development team through financial analysis and valuation process for investment and other business development opportunities. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Associate Director FP&A position is an integral part of the finance team supporting ... on reasons for any variances and implications on business performance. Works with Director of FPA to streamline and improve reporting to offer management insights to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... strategy for the RBQM function within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable for innovation, standards, processes and infrastructure in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts ... with a comprehensive and all-encompassing approach to coordinate activities, under the leadership of the Head of Functional Excellence, across key functions to improve the benefit-risk in patients treated within the oncology compounds throughout the course of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; ... Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOverviewThe Associate Director of Federal Tax Audit plays a crucial role in supporting the audit function within the Tax Department, reporting ... directly to the Director of Tax Audits. This position is responsible for...compliance and effective audit execution.The Federal Tax Audit Associate Director will be responsible for preparing responses to Internal… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action.- The DD&T Team manages the development of the device constituent of our… more
- Merck & Co. (Rahway, NJ)
- …support for Oncology programs.- The position reports to the Senior Director responsible for Portfolio Real-world Evidence (RWE) in Oncology.- -Position objectivesTo ... design and execute real-world evidence studies, designed to demonstrate the value of new products in support of HTA, reimbursement, provider, payer and patient decision-making.To provide outcomes research leadership and consultation on advanced evidence… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Merck & Co. (Rahway, NJ)
- …patient access through innovation in patient access models and solutions.The Director , Global Market Access, PAP (Pharma Access & Pricing) Ophthalmology will ... and reimbursement strategy for our ophthalmology products. In this role, the Director will lead the development and execution of global market access strategies,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory ... Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and experience with IT System/Business System Management.Education Min. Requirement: BS/BA or an equivalent certification/experience in science, engineering, IT… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...like peptides, novel biological constructs, and others. The Associate Director is a skilled quantitative drug developer, with a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic ... are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise… more
