- 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 ... leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the...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)
- …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)
- …products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the ... 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)
- …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)
- …newsletter. Reviews all drafts of committee communications and responses. - The OEDC Program Lead leads an agile team in a rapid growth environment and conducts ... disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the...focused centers. This role will help the OEDC Leadership Team (OLT) to accomplish its vision to promote innovative,… 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)
- …has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program in CSPV ... organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and risk management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skillsets, to develop new ideas and insights, including takeaways about yourself as a leader Interns will be assigned to projects to help and support the regulatory ... able to manage multiple tasks and to work independently and as a team member. Students with demonstrated leadership skills in projects at home and abroad… 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)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of… 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)
- …global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader of the GRT (Global Regulatory Team )The primary point of contact with ... review of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input… 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)
- …visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip ... CRO CRA monitoring oversight and share findings with appropriate stakeholders/ team leadership.Collaborate on the development of monitoring plan templates including… 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)
- …is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and ... and assisting in preparation of regulatory sections.Schedules rapid response team (RRT) meeting, creates response templates and coordinates processes for… 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)
- …SummaryThe Manager, Medical Content for the Medical Content and Training (MCT) team in Global Oncology Medical Affairs (GOMA) will support the development of ... and ensure accuracy and scientific balance. As part of the medical review team , the manager is responsible for conducting comprehensive medical reviews and clearance… 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)
- …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
