- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, ... Management & Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead ...resolve or escalate study issues /risk mitigations to the Operations Program Lead and study… more
- Eisai, Inc (Nutley, NJ)
- …unlawful actions.Oversee system data retention standards and verify system operations .Manage Eisai's information governance program , including JSOX ... security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, ... relevant governance bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence… more
- Merck & Co. (Rahway, NJ)
- …validation, injection molding, automated assembly, and human factors analysis)Maintain a high level of engagement in the program -specific design controls process ... Job DescriptionDevice Development Principal Scientist - Device Development Lead (Director Equivalent) Our company's Device Development (DD) Team designs, develops,… more
- Merck & Co. (Rahway, NJ)
- …and aspiration of our Company's digital (Chemistry, Manufacturing, and Controls) CMC program to set the foundation for a digital continuum from development to ... manufacturing for our products and processes. The digital CMC program is a multi-year investment, and will need to...strategies - across the full technology stack across of Operations , Supply and Quality.- The resultant standard architecture must… more
- Merck & Co. (North Wales, PA)
- …Responsibilities: -Portfolio and Project Management (~50%)Responsible for aggregating individual program information to a portfolio viewEstablish robust CMC and ... appropriate tools, dashboards, and business systems.Manage cross divisional workstreams and lead or input into improvements to processes / templates that support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Overview The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for leading a team of microbiology data reviewers supporting ... manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead QC Microbiology… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA and QC oversight ... which include oversight of raw material qualification, lab investigations, stability program , etcProvide oversight of QC equipment program , which includes… more
- Insmed Incorporated (Bridgewater, NJ)
- …and Best Workplaces for Millennials™ lists.OverviewReporting to the Vice President of Program Management, the candidate will be responsible and accountable for the ... successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program management support to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Science (CS) Group Lead will be responsible for overseeing multiple program - level CS Asset Leads who are managing a team of clinical scientists ... throughout the project life cycle is optimized across multiple programsThe CS group lead will also contribute to the program study strategy, planning, execution,… more
- Merck & Co. (Durham, NC)
- …and embraces an inclusive team culture including significant interaction with Operations , Quality, Automation, Technology, and other groups as required.The Lab ... Maintenance Technician will provide maintenance supporting vaccine process equipment operations . Takes appropriate action to correct Plant Engineering maintenance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program ... and market access discussions for select indications.Support as medical lead for select company-sponsored GMA evidence generating studies/projects. Manages all… more
- Insmed Incorporated (Bridgewater, NJ)
- …the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic ... will have responsibility for the management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization,… more
- Merck & Co. (Rahway, NJ)
- …you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of impactful ... across the HHDDA portfolio. In addition, you will also lead a team of highly talented individuals working on...to shape the vision, strategy, and roadmap of domain level analytics ready datasets.experience in large scale multi country… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …be preferable. Responsibilities Leadership, Direction, and Strategy:Leads implementation of Program /Therapeutic level external data collection requirements by ... planning/start-up, conduct and close-out of external data management activities by managing Program / Therapeutic level external data collection process, study… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, ... New Jersey. Role Overview The Quality Systems Lead role is an exempt level position...for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA program for the CAR-T… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program ... peer-to-peer discussions, and collation of insights.- Serve as medical lead for select company-sponsored GMA evidence generating studies/projects. Manages all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training materials and content on the speaker engagement platform.ResponsibilitiesProgram Operations : Lead the coordination of speaker bureau nomination process ... are following compliance with all DSI requirements and meeting all service level agreements.Analyzing speaker program data, provide reporting and maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …maintaining innovative technology solutions for Meetings and Events, ensure smooth operations , and collaborating with vendors to optimize services and achieve ... selection process- Collaborate with vendors to define and manage service- level agreements (SLAs), ensuring compliance and high-quality service delivery- Monitor… more
- Novo Nordisk Inc. (Boulder, CO)
- …The Senior IT Engineer I - Labs will be responsible for ensuring operations of existing local laboratory IT infrastructure as well as pursuing novel solutions ... Labs will therefore be working closely with research and operations staff in Lexington, MA as well as with...in Boulder, CO and reports to the Lab IT lead in Lexington, MA. Additional internal stakeholders include IT… more
