- Merck & Co. (Rahway, NJ)
- …with partners and value teams, ensuring strategic alignment across the product line.Discovery and Prioritization: Lead product line-level discovery ... objectives, and ensuring that these are well defined with measurable outcomes.- Product Line Lead , Workplace Services' primary responsibilities include, but not… more
- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs...field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical development,… more
- Merck & Co. (Rahway, NJ)
- …candidate will lead a cross functional insights team that spans data science, market research, data strategy, and measurement.The preferred candidate should ... Job DescriptionThe Associate Director Data Science will be responsible for developing and...be an independent contributor as well as be a lead partner in helping to scope, design, and deliver… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategic Application product roadmaps to meet business goals and objectives. Lead the definition of solutions based on business needs, cost, and required ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed and ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Merck & Co. (Rahway, NJ)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization and join the leadership team of Small Molecule ... for three core areas within SM S&T: (1) technical product leadership across the lifecycle of product ...into the organization.Drive innovation and productivity enabled by robust data analysis. Responsibilities include, but are not limited to,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the GCL, if applicableDelivers all relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit-risk ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the… more
- Merck & Co. (Rahway, NJ)
- …is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision ... a team of crystallization subject matter experts, the Crystallization Lab Lead collaborates with cross-functional teams to ensure small molecule Active… 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, ... collaboration skills.-A strong track record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …scientific understanding and capability builds within the organization.Primary Responsibilities:Responsibilities: Lead development of new, innovative approaches for ... of the drug development processDemonstrated ability to independently design, execute and lead complex experiments and data analysisTrack record of working… more
- Merck & Co. (Rahway, NJ)
- …This role includes the comprehensive preparation and submission of combination product sections for both commercial and investigational products, such as pre-filled ... include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional teams to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This ... position will be a member of the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead … more
- Merck & Co. (Rahway, NJ)
- …execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate directors. ... leaders and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders. They...guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I… more
- Merck & Co. (Rahway, NJ)
- …closely with PMO Leads, technical leads, software engineers, architecture team, product managers, vendors, other technical project managers, and business functional ... on technology and process transformation, simplification and innovation to:Invest in data that fuel innovationModernize our current state clinical technology and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of… 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 ... Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based assessment… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.Ability to design, execute… more
