- 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)
- …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)
- …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)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... innovative, science-driven portfolios with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to drive strategy and… 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
- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical ... and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross functional Clinical Study Oversight… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …globally. We are currently recruiting for an Associate Vice President (AVP) to lead global marketing for our Global Ophthalmology Franchise.For more than 35 years, ... and Global Commercial Leader, Infectious Diseases, Neuroscience & Ophthalmology.Primary Responsibilities: Lead the development and execution of the Global Marketing… more
- Merck & Co. (Rahway, NJ)
- …of our communications efforts.Scope of work and core responsibilities include: Lead the development of communication strategies grounded in data insights, ... strategies.Guide vision and structure of enterprise social intelligence operations, serving as lead contact for all social intelligence needs.-Stay up to date on the… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... of impact to automation systems with IT driven firewall rule changes. Lead /assist project scopes, define IT and infrastructure deliverables, timelines and estimates… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has primary responsibility for the ... group and in the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical development, including development strategy, study… more
- Merck & Co. (Rahway, NJ)
- …Ophthalmology will be a member of the GMAx Pharma leadership team and will lead a team across the ID&O portfolio.T he Executive Director, Global Market Access, ... this role, the Executive Director will work collaboratively across the enterprise and lead the team in development and execution of global market access strategy,… more
