- Merck & Co. (Rahway, NJ)
- …Phase Clinical Supply and Technology Innovation implementation into the pipeline.The Director Manufacturing Operations (m/f/d) leads an Operating Unit ... and continuous manufacturing -with a Quality First, Safety Aways Mindset. -The Director Manufacturing Operations (m/f/d) leads teams responsible for Technology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular ... file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the assigned… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssoc. Director of Support Operations (m/f/d)The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping ... Supply and Technology Innovation implementation into the pipeline.The Assoc. Director of Support Operations (m/f/d) will be a member of the Biotech Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP Operations , will oversee laboratory compliance across multiple ... Job Description Job Description: The GMP Operations branch of Biologics Analytical Research & Development...for a team of 8-10 scientists. Our BAR&D GMP Operations team validates analytical methods and performs release and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems and Operations Intern to work closely with the Director of Publications ... Operations to optimize department resources for delivery of high-quality medical publications in an efficient and compliant manner. They will assist in the operation and governance of iEnvision, an internal global publications database system, as well as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , Insights & Analytics is responsible for leveraging data-driven insights and advanced analytics to shape communication strategies, ... data sources that inform the strategy and execution of corporate communications. The Director , Insights & Analytics will work closely with IT, the company's social… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Global Oncology Commercial Pipeline Analytics, HHDDAOur Human Health Digital Data and Analytics (HHDDA) organization is charged ... digital, data, and analytics to measure our organizational impact.The Associate Director , Global Oncology Commercial Pipeline Analytics, HHDDA will be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... Start-Up activities for PV Safety Operations . This position oversees the creation of SAE Flow...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: The Associate Director , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... drives coordination of global and US regulatory activities. The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …growth. These responsibilities will include management of all day-to-day payroll operations and activities for all US (multi-state) and Canada regions, ensuring ... the candidate possesses significant domain experience with the DSI payroll operations preferred- ADP Vantage Certifications preferred Experience Qualifications- 7 or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include but are not limited to Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative ... Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quantitative value delivered to the business. Works closely with Procurement Operations to integrate the Small Business Administration plan and continuous ... improvement into the sourcing activities. Supports supplier diversity initiatives and promotes sustainability best practices. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and strategy for process improvement initiatives as a member of PV Operations leadership. Qualifications: Successful candidates will be able to meet the ... qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree Bachelor's degree in nursing, pharmacy, life sciences, health care or related field is required- Master's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Local DSI CSPV SystemsMonitoring disruptions in customer service and internal operations , while ensuring the highest level of qualityCollaborate with internal ... stakeholders - including IT and business resources, contracts, and procurement - to develop criteria and best practices for vendor selection.Establish and/or approve internal and external policies, standards, and processes for vendor interactionServe as the… more
- Insmed Incorporated (New York, NY)
- …Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include trial site ... identification, ongoing recruitment motivation, and issue/problem solving.Provide medical and scientific support to payers, commercial managed markets, and related health care organizations to facilitate access to Insmed's medications for appropriate patients.… more
