- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with project teams to analyze solution requirements and produce preliminary solution design and architectural diagrams. 35 E- Lead technical feasibility ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Merck & Co. (Rahway, NJ)
- …core understanding of the drug development processDemonstrated ability to independently design , execute and lead complex experiments and data analysisTrack ... and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good Manufacturing Practice (GMP)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure effective transformation and automation across the organization. Responsibilities Process Design , Development, and Optimization:- Coordinate and lead the ... global IT Governance and Project Assurance.- Take on global cross-functional BPM lead functions to implement and influence BPM strategy, including conducting process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications solutions implementation teams (including external vendors) in the design , development, implementation, validation, roll-out, training and support of ... global and regional DS applications to meet business needs using a standard methodology. Oversee applications support groups' system validation and change control process. Collaborate with the Services organization to ensure smooth transition from system… more
- Merck & Co. (Rahway, NJ)
- …safety and industry guidance are preferred.- Candidate should have demonstrated ability to lead a cross functional team through design and execution, while ... sharing of lessons learned and drive efficiency in execution of project deliverables.- Lead or participate in Engineering Design review sessions.-Ensure that… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary Responsible for managing the design , development, optimization and administration of global HCM Platforms and processes. ... This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing deep understanding of HR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy, design , execution, and interpretation of Oncology clinical trials. Serves as a ... a physician's perspectiveMay provide clinical input into the eCRF (Case Report Form) design , participate in the UAT (User Acceptance Testing) and CCG (CRF Completion… 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
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design ... Product Development & Commercialization (SDPC, our Manufacturing Division ) in the design of new formulations and development of robust and scalable processes for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and Central ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary Position leads complex studies in study design , statistical analysis and interpretation of results with some supervision. This ... report (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review, SAP development, analysis files development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …report (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review, SAP development, analysis files development, ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… 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 m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific/technical experience to: (i) lead and contribute to assigned late-stage Active Pharmaceutical Ingredient (API) ... mentor junior staff within the CCT organization, and (iii) lead or support internal and external development with line...learning and utilizing Quality Risk Management (QRM) /Quality by Design (QbD) methodologies and tools around the statistical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and meet increasing project demands. Program Management: Guide Program Managers to design and charter programs to efficiently plan, execute, and manage a group ... to realize overall program benefits in alignment with the organization's strategic objectives. Lead PgMs and PMs to manage the delivery of approved IT programs and… more
- Merck & Co. (Rahway, NJ)
- …and solving incidents, problems, identifying root causes and performing crisis management roles. Lead efforts to map and design operational service architecture ... and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that… 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
