- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global product... for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of PJ Lead and Tech Unit.- Provides leadership in the project/development team , as Matrix Lead , interfacing with various site locations globally and on ... research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analytics, testing, and integration, to ensure cohesive and comprehensive service delivery. The lead will provide technical leadership, guiding the team in the ... are met according to agreed timelines and quality standards. Lead a team of professionals specializing in...agreed timelines and quality standards. Lead a team of professionals specializing in intelligent automation, solution architecture,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …depth medical knowledge to provide insights and support to the cross-functional GOMA team including TA lead , medical information & education, patient advocacy, ... medical activities for assigned TA in coordination with GOMA SE lead and other relevant cross-functional stakeholders, and collate for reporting to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as developing activity plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by working with ... holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing...chair of PAC-MT, etc.Manage (or have subordinates manage) project team by working with other L-1 functions to get… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. ... accountable for supporting divisional and departmental level objectives and may also lead a non-project initiative in support of these objectives. This position will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections in the US, in collaboration with the Global RD/PV QA team .RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional ... assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is in...perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently...team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently...team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead respective workstream(s) to gather, document, implement and validate all system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and ... stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the external innovation ecosystem, internal stakeholder communication, and GBD team training & development efforts. This experienced leader will ensure ... associated communications, identifying and supporting thought-leadership opportunities for the team , and more. Supports corporate communications with messaging and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. ... performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory ... resource management, and clear communication with stakeholders and the project team . The Project Manager identifies and mitigates risks, maintains high-quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Assistant to provide comprehensive support to leaders and members of GMP Quality Assurance team and will serve as the primary point of contact for internal and ... decisions and overcomes challenges using experience and resourcefulness and may lead lower levels in prioritizing and distributing workResponsibilities for the role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment, ... meetings; leading negotiation sessions in concert with senior GBD Transactions team members; and alliance management participation following successful completion of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally, this position ... Management Plan, and dictionary coding synonym list. Coordinate with Data Operations Team on coding dictionary set up, registration of dictionaries, and responsible… more
