- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... leadership team. This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … governance approach/framework with a continuous improvement mindset. Coordinate GRA's data strategy with broader corporate IT projects and objectivesCollaborate ... with Corporate IT to align GRA's data strategy with the overall...preferred)2 or more years Familiarity with pharma and regulatory information management systems (RIMS); Veeva Vault experience preferred. Travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …decision making would be preferable. Responsibilities Leadership, Direction, and Strategy :Leads implementation of Program/Therapeutic level external data ... Data quality checks, External Data reports and / orExternal Data listings.Remains current with and disseminates information about external data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Strategy : Leads implementation of department-level strategies for external data management activities and drives consistency of data acquisition, ... SOPs, SOIs, and associated guidelines. Remains current with and disseminates information about external data trends and advancements, regulatory requirements,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that includes veterans and people with disabilities.Summary Reporting to the Disease Area Strategy Team (DAST) Lead for GU Cancer, this position is integral to R&D ... and partners with the DAST Lead to build and execute a disease area strategy across the ADC portfolio plus emerging pipeline assets to advance our research and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. SummaryReporting to the Disease Area Strategy Team (DAST) Lead for GU Cancer, this position is an integral ... R&D and partners with the DAST Lead to build and execute a disease area strategy across the ADC portfolio plus emerging pipeline assets to advance our research and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PV QA and Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents ... has advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all disciplines within the Daiichi Sankyo organization to obtain and/or provide information / data for regulatory filings.May serve as the single regulatory ... growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and maintenance of analytics platforms, tools, and processes to drive data -driven decision-making, enhance analytics capabilities, and contribute to the success of ... Lead the development and execution of the digital and omnichannel analytics strategy , aligning it with the overall business objectives. Develop and maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the DMC in the open session- Reports on/prepares presentation material of trial safety information / data to internal and external safety boards (eg, DMC, SC, Ad ... Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical program designed to support registration and develop value-enhancing life-cycle strategy . The GTL is the GPT Leader, directly accountable for conceiving, ... designing and implementing product development strategy and delivery for their asset(s). The GTL has...plans, and addressing all regulatory, drug and patient safety, data , CMC, IP, patient selection, market acesss and and… more
- Merck & Co. (Rahway, NJ)
- …processes for data product owners, data analysts and scrum masters.Leverage data domain knowledge to shape the vision, strategy , and roadmap of domain ... Job DescriptionPosition Description: Associate Director Data Product Management Job Description We are seeking...with key vendor partners to shape the overall staffing strategy and continuously ensure high quality deliverables and optimized… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position ... and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication. Responsibilities Support GMA the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan for select ... indications/projects related to evidence generation, medical information and internal education, publications, scientific exchange and external data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …author safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information , Company Core Data Sheet (CCDS), Risk Management Plan(s) ... and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential safety signals,...Safety Physician(s), PSL, and cross-functional team to develop safety strategy , key safety messages, and review and author safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementing, and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across various ... of performance, scalability, and reliability.- Drive the organization's GenAI strategy forward as a member of the GenAI Center...Gen AI security and governance policies to ensure that data is collected, managed, and used in a responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of data as well as market supply base information for their categories ... multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of high dollar… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Enterprise Strategy Office (ESO) develops, implements, and drives enterprise strategy in support of our company, its customers, and ... implementation and cross-functional engagement. Position Description: The Director of Commercial Strategy will lead and support strategy development for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy for gynecological oncology indications/projects related to medical information , internal education, publications, scientific exchange and external ... Review Committee meetings.- Collaborates across functions to support GMA Medical Information Education activities to achieve approval of key scientific communication… more
