- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure that deliverables are met according to agreed timelines and quality standards . Lead a team of professionals specializing in intelligent automation, ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies...the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... & Operational Excellence, the assigned Global Medical Affairs Team (GMAT) or Functional Lead , and the Franchise or Function Head to deliver GOMA projects and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements), including conduct of impact assessments and implementation of changes as required. Lead development and maintenance of RBQM standards such as ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... quality and risk management reporting requirements that adhere to programming standards and specifications across clinical studies. This position involves managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... and immune disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... organizational efficiency and decision making.Responsibilities: Project ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development projects/programs.… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting ... and vendor oversight. The Sr. Director ensures compliance with cGMP standards , oversees QA activities at CDMOs, performs critical documentation reviews, and… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionWe are seeking a seasoned Staff Engineer to lead our AI Foundations Team-a new initiative dedicated to establishing the core ... ecosystem, we'd love to hear from you. ResponsibilitiesArchitectural Leadership: Define and lead the end-to-end design of our AI Platform, ensuring robust, scalable,… more
- Formation Bio (New York, NY)
- …of quality systems to ensure adherence to regulatory requirements, industry standards , and best practices in pharmaceutical manufacturing and defending it during ... (QMS) to ensure compliance with regulatory requirements (eg, FDA, EMA), industry standards (eg, cGMP), and company policies. Establish and maintain quality assurance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... areas centered around rare diseases and immune disorders. SummaryAccountable to lead , manage and ensure that all Contract Manufacturing, Testing and Warehousing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... and prioritize improvement opportunities with the greatest impact.Process Optimization Lead initiatives to standardize, simplify, and optimize core processes across… more
