- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product ... plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by...group leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of ... services are developed, implemented, tested, and integrated efficiently and effectively. The Lead will define and drive the methodology, approach, and best practices… 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)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaborate cross-functionally with stakeholders to align IT projects with business goals, gather input, prioritize initiatives, and develop functional IT roadmaps in ... alignment with Daiichi Sankyo's mid-term goals. Aid in the delivery of a strategic short- and long-term IT transformation plan to business, ensuring continuous improvement and optimal solutions that support business processes as well as unmet business needs.-… more
- Merck & Co. (Rahway, NJ)
- …in the role of Human Health Digital, Data and Analytics (HHDDA) Shared Services Lead . In this capacity, this role will help HHDDA realize the aspiration for the ... partners across the Globe. - Specifically, the HHDDA Shared Services Lead will:-- Shared Services Team Lead Serve as people manager to a team of Administrative… more
- Merck & Co. (Rahway, NJ)
- …of diseases in people and animals. In the capacity of a Global Labeling Lead , you will be instrumental in shaping the labeling strategy and ensuring the development ... you to demonstrate your superior execution skills.Core ResponsibilitiesAs a Global Labeling Lead , you will guide cross-functional teams in the creation, review, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities for supporting the document ... management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… 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)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of...new products or products in the development phase. Independently lead cross functional teams through all labeling discussions with… 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 ... (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure (IB): author the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of...new products or products in the development phase. Independently lead cross functional teams through all labeling discussions with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to any therapeutic ... 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)
- …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 ... site training material as stated in the CSOPSupport and/or lead mitigation of CRO/vendor oversight findings. Additional Collaboration Opportunities:Support strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk ... and leadership. Provide coaching, motivate, direct, and foster teamwork, lead cross-functional, multi-cultural teams to develop talents among CSPV organization.… 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, ... proposal/review/negotiation of EOI/NBTS and Definitive Agreements, either acting as Lead for simple opportunities or supporting more complex transactions. Work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. ... labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
