- Merck & Co. (Rahway, NJ)
- …the Sterile Product Development (SPD) leadership team to support the strategy and operations of the organization. This position will have an opportunity to represent ... the SPD function on key strategic initiatives and a variety of opportunities for cross departmental collaboration (eg Finance, Quality, Procurement) across the development areas collaborating with various chiefs of staffs.The incumbent will report to the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Facilities Cleaning Program Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Facility ... This person will communicate and provide updates 1st shift facilities and operations teams. The lead will work closely with the cleaning team to ensure all 3rd… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job Summary: The TA Oncology Strategy and Execution Lead is a pivotal leadership role responsible for driving the strategic and ... TA Oncology organization The incumbent will be expected to independently lead cross functional initiatives intended to build capabilities, improve processes, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations , Regulatory Affairs CMC, and Clinical Development to collate the ... Initiatives in close collaboration with RD colleagues.Drive discussions with Clinical Operations and the scientific SMEs, prepare and Coordinate responses to queries… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for ... at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure successful implementation ... of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally For late-stage programs, executes the Diagnostic development strategy for… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: - Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw ... development, and seamless technology transfer to commercial sites. The SSO Operations Specialist will provide hands on assistance for daily production activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respond appropriately to these concerns, barriers, and the evolving marketplace. The role will lead the training efforts and support the needs of a variety of DSI ... Director is also responsible for gaining cross function inputs and lead the projects' execution, tactical implementation, and sustainment leading to improved… more
- Merck & Co. (Rahway, NJ)
- …quality measures specified in local SOPs- - Data Centric Business System Owner Operations : Lead the regulatory data governance and standards team, which manages ... are not limited to: - - Data Centric Submissions: Lead the data submissions team that is accountable for...and mediation, ownership, and stewardship roles, including business system operations .- Veeva ARC : Play - - ing a… more
- Merck & Co. (Rahway, NJ)
- …and external stakeholder engagement, working in close partnership with the operations lead .Specific responsibilities include:Oversee the team of Regional Privacy ... and regulators. -The other team drives program governance and privacy operations , supporting privacy compliance through the development and maintenance of program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employer including veterans and people with disabilities.SummaryThrough strategic leadership, lead and manage skills and capabilities development initiatives for the ... through established interactions with Japan and Europe as required.Responsibilities- Lead the Global Finance and Procurement Capability Building Program- Design… more
- Merck & Co. (Rahway, NJ)
- …Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with ... is seeking a dynamic and versatile leader for External Manufacturing Operations , Drug Delivery Systems and Devices within our Manufacturing Division (Associate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced ... Leadership, Direction, and Strategy:In collaboration with Clinical Development and Clinical Operations as well as other BDM functions, sets the vision, direction,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiatives and implementation of changes and projects. The support of daily operations (incidents, service requests, changes) for the functional modules in scope is ... Implement best practices to enhance efficiency and effectiveness in sales operations .Ensure the SAP SD/MM modules integrate seamlessly with other SAP modules… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role is responsible for partnering with DS internal senior stakeholders to lead , assess, develop, negotiate, and execute strategic sourcing activities (both US and ... procurement policies and methodologies are understood and utilized. Serve as the lead "relationship manager" to deliver best practices to the business partners.Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and other internal groups) and ... development staff.Consults with KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the site level to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or other external process steps where appropriate.Ensure and execute smooth operations and technical support of the relevant HRIS Module(s) including technical ... and support materials for end-users, handling of queries, troubleshooting, and quality control. Lead or support consulting and implementation projects in the area of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Contamination Program Lead as part of the Technical Operations team based in Raritan, NJ.Role OverviewThe Contamination Program ... Lead will be responsible for creating and maintaining the...than 8 years of experience in Technical, Engineering, and/or Operations in a GMP production environmentExperience conducting, supporting, reviewing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… more
