- Aequor (Piscataway, NJ)
- …Using Acadia's eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority ... guidelines and industry best practices. For authored documents, ensure formatting is applied consistently according to Acadia's Style Guide. As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …: Leadership, Direction, and Strategy: - Establishes Data Management deliverables and expectations at the study level.- Proactively identifies and manages risks to ... data quality and/or timelines at the study level and escalates issues to the DM program lead.- Will manage DM resources of assigned studies; provides FSP/Vendor oversight for end-to-end Data Management activities.- Acts as a core member of the Study Team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position oversees ICSR Standards activities, projects, and procedures. This level interacts within global CSPV and with CROs, vendors, and partners; and ... participates on interdepartmental study teams. This level handles escalated global CSPV case processing issue and handles project. This position prepares trainings, supports CAPA investigations, case review, documentation reviews in collaboration with the ICSR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, ... both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... 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)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... university) Bachelor's Degree in a scientific, healthcare or related discipline required Experience QualificationsMust have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will vary depending on the stage of development of assigned projects (ie, Phase I through commercialization). ResponsibilitiesDepending on the status of development ... 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)
- …below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Must have a Bachelor's Degree Bachelor's degree ... 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)
- …below with or without a reasonable accommodation.Education (from an accredited college or university)Bachelor's Degree in Computer Science, Life Science, Engineering, ... 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)
- …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)
- …- Group strategy: Sets the vision and strategy for the group including overall vision for a robust risk assessment, mitigation, central (statistical) monitoring 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)
- …positions from Director through Vice President, as needed, and in so doing will provide direct assistance to the project teams, committees and the ... department/function.Attend GPT meetings and assist in creation of drafts of presentations, meeting agendas and action items.Utilizes independent judgment and makes decisions in responding to questions related to assigned matters, processes, and procedures as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... 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)
- …Business Analysis: Analyze sales and marketing business requirements and translate them into functional specifications for Veeva CRM. Collaborate with business ... 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data management strategy across regions. This position is ... 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)
- …Analyse, design and configure processes related to sales and distribution (supply chain management) and material management in the global ERP landscape, develop high ... level solutions for new demands from business and provide input for business casesCollaborate with business stakeholders to gather and document requirements, translate business requirements into technical specifications for the SAP SD module.Propose measures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... university)Bachelor's Degree in Accounting, Finance, or related field requiredMBA in Finance preferred Experience Qualifications 7 or More Years experience in accounting and/or Financial Planning and Analysis-related work, and/or pharmaceutical/R&D experience… more
