- Merck & Co. (Rahway, NJ)
- …and enhance the efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the development and maintenance of ... seeking a highly qualified and experienced Associate Director in Data Management to lead our data...numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data… 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
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… 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)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... not limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative) such as clinical development,… more
- Merck & Co. (Rahway, NJ)
- …benefit of patients and global human health.This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders. ... with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the data into analysis/modeling datasets, and… 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 ... division and IT, including scientists, engineers, IT architects, infrastructure, quality , vendors in building, optimizing, and troubleshooting the OT automation… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be ... remove barriers on portfolio or scientific prioritiesEvaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging… 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)
- …Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications ... for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform ... around rare diseases and immune disorders. Summary The Manager, Data Programmer is a member of the Biostatistics and...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are ... and external cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and… more
- Merck & Co. (Rahway, NJ)
- …on technology and process transformation, simplification and innovation to:Invest in data that fuel innovationModernize our current state clinical technology and ... while being able to influence to gain alignment with stakeholders through use of data and logic.Support creation and management of all aspects of a given project,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of ... 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)
- …ensuring that these are well defined with measurable outcomes.- Product Line Lead , Workplace Services' primary responsibilities include, but not limited to :Vision ... teams, ensuring strategic alignment across the product line.Discovery and Prioritization: Lead product line-level discovery activities, prioritize problems and opportunities,… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional teams to ensure ... agency background packages, post-approval submissions/variations, 510(K)s, CE markings. - Lead the development, communication, and review of Regulatory Strategies… 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 ... of small molecule, peptides and biologic modalitiesReview and approval of data and technical documents including critical evaluation of predictive modelsAbility to… more
- Merck & Co. (Rahway, NJ)
- …solving.Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... 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… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, ... The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and… more
