- Merck & Co. (Rahway, NJ)
- …the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of the organization, from ... that balances user desires with technology capabilities.Develop and maintain product materials, including training documentation, SDLC documentation, and product… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively planning, ... wide range of functions in Daiichi Sankyo (DS). Reporting to the Sr. Director , Enterprise Program Management, this position requires a capable leader with strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …success of product messaging, programs and promotional effort. The Associate Director is also responsible for a broad array of brand functions including ... research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Consumer Marketing serves as the patient, brand and product … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director...strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... Marketing leadership to oversee and execute all aspects of field-based programs, product theaters, & national broadcasts in conjunction with the Brand teams. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development, commercialization, market access, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... on customer insights, external landscape, and internal information including overall product development plans.- Proactive planning for asset milestones to account… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product strategy based on a cross functionally designed strategy, as well as ... plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by working with other L-1 functions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Lead the definition of solutions ... with the business users to define user information needs, research innovative product value proposition and collect ideas for future roadmaps and planned projects;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned project(s).Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting ... breakthrough therapy designation requests, orphan drug applications.Participate in global product team meetings (development and marketed products); provide regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to ... or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget. ... Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …providing forecasting & financial support to Brand Teams by assisting product directors/ managers with strategic planning and financial consulting, leading financial ... planning and net revenue forecasting processes.The person will own and facilitate the forecasting process to develop P&L projections for the inline and pipeline brands, partner with various functional groups to provide financial assessment, communicate results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …display, results validation, interpretation and reporting to accelerate worldwide product submissions and approvals.Drug Development Strategy: Reviews and provides ... strategic input to entire portfolio or specific therapeutic areas from Phase I through life cycle management. Briefs senior management on assigned projects or studies as needed. Subject matter expert in multiple therapeutic areas.CRO / Vendor Oversight:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Work with User Support Leads ... and the business users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications solutions to meet business needs.Assemble applications solutions… more
