- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: The Office of General Counsel is seeking an Associate Director, Trademark Operations to provide docketing and legal ... Property (IP) organization. Primary responsibilities are to oversee the Trademark Operations team, including operations and workflow; partner with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… 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)
- …areas 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations . This position oversees the creation of SAE Flow Plans and may ... activities. This position will interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members.… 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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …Modeling Team in our Company Manufacturing Division seeks an experienced Associate Principal Scientist who will develop and utilize advanced computational models ... substance (upstream, downstream, and conjugation) and drug product manufacturing unit operations using a variety of process-modeling tools.-As a potential candidate,… more
- Merck & Co. (Rahway, NJ)
- …disciplines: Knowledge of IAM, Network Security, Endpoint Security, Security Operations , Risk and complianceStrong Grasp of Architectural Principles and ... Technologies: Deep familiarity with modern architectural methodologies including serverless architectures, microservices, and the principles of DevSecOps. Ability to leverage these technologies to deliver innovative and effective security solutions that align… more
- Merck & Co. (Rahway, NJ)
- …individual to join our Downstream Process Development and Engineering group as an Associate Principal Scientist.- In this role, you will work with a highly ... and activities include designing and optimization of downstream unit operations such as cell harvest, filtration, chromatography, viral clearance, precipitation,… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... team, Quality Control, Information Technology, maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiatives/projects and improving the efficiency and/or effectiveness of internal operations of MCT.Responsibilities- Provide MCT system support and access ... (from an accredited college or university)- High School Diploma required- Associate 's Degree preferred Experience Qualifications- 1 or More Years overall related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study Start-Up: ... Plan, and dictionary coding synonym list. Coordinate with Data Operations Team on coding dictionary set up, registration of...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure accuracy and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking a Supervisor, Maintenance (3rd shift) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Supervisor, Maintenance is an ... exempt level position working within Technical Operations team. This individual will be responsible for managing facility maintenance activities, including… more
- Merck & Co. (Rahway, NJ)
- …proficiencies. -To focus on realizing this objective, we are hiring an Associate Director, Technical Capability Business Engagement. -The person in this role will ... through IT, ensuring long-term adoption and integration into daily IT operations .Collaborate closely with IT leadership and cross-functional teams to embed new… more
