- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, ... This position (GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are tracked and ensure implications are assessed and communicated on timely manner- Clinical Development Life Cycle Management Decision Support: Be the key point ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...launched brands. The role will be responsible for the development and maintenance of Short to Long Term Forecasts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...from a medical strategy standpoint to the development of clinical sections of study-level documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Standards is responsible for the development and sustainability of the Global Clinical Data Standards for quality submissions and success of the Daiichi ... the appropriate levels of the Standards framework.Participate in review of Protocols, Global Clinical Libraries, Standards package, etc. to enhance efficiencies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy : Provides the strategic ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the fabric of Daiichi Sankyo.Responsibilities- Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC ... disease strategy and the strategic choices for clinical development and data generation- Develop and...or leading change management initiatives preferred- Prior experience in clinical development , Medical Affairs, or Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy : Clinical study ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...early development plan and contributes to overall development Strategy ; Develops program biomarker strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …learning cross functional roles and responsibilities such as (but not limited to) Clinical Development , Global Medical Affairs, Biostatistics, Clinical ... zones such as Japan. Education/Experience: o Express an interest in Leadership and Global Research and Development Drug Processes. Prior experience in project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing strategy for respective categories. Builds and ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development , Research Development , Regulatory Affairs. Facilitate ... research areas centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy , design, execution, and ... when needed- Clinical Development Expertise Strategy - In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThe Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy , design, execution, and ... and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable, leads the … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...Daiichi Sankyo, and where applicable, partner companies for the development and approval of US, EU and global… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will ... collaborate with global , cross-functional team members including clinical directors and study managers to lead/support clinical trial scientific activities… more
- Merck & Co. (Rahway, NJ)
- …and monitor performance across our portfolio, studies & processes within Global Clinical Trial Operations (GCTO).Primary responsibilities include but are ... and reports to measure operational performance.-Defines release training and communication strategy .- Coordinates development and delivery of training and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance oversight is in place and all regulations being adhered to.Ensure that Clinical Development activities (ie , protocols) are aligned with GLP/GCLP, ... partners and collaborators.Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities and… more
- Merck & Co. (Rahway, NJ)
- …Ophthalmology.Primary Responsibilities:Lead the development and execution of the Global Marketing Strategy for the Ophthalmology Franchise.Drive launch ... of our key products is currently in Phase 2b/3 clinical trials for the treatment of diabetic macular edema....commercial input on activities such as target product profile development , global regulatory filing strategy ,… more
- Merck & Co. (Rahway, NJ)
- …DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy , Design Controls and Risk Management Our company's ... projects.-Lead the implementation and/or ensure effective execution of the device development strategy , design controls and risk management activities for… more
- Merck & Co. (Rahway, NJ)
- …- The position will require: Outstanding leadership in market assessment, disease state strategy , product clinical development , product strategy , market ... Leader engagement execution, competitive strategy , target product profile development , health authority interactions, global regulatory filing strategy… more
