- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by identifying efficiencies, cost effectiveness and improved ways of working.Provide leadership to Clinical Operations staff and to project teams for Vendor ... meetings on behalf of the Study Management Group Heads and/or Vice President, Clinical Development Operations .Contribute to and/or lead in the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsibilities:Develops and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label ... updating relevant Trial Master Files (TMF) with CSO-related documents.Supports the CSO Project Mgmt Lead in executing additional operational and logistical… more
- Merck & Co. (Rahway, NJ)
- …Molecule VCM Product Leader (PL) is the end-to-end (E2E) supply chain lead responsible for developing and executing product supply strategies for one or more ... ultimately affects access, continuity of supply, and commercial outcomes. The VCM Product Leader will lead the cross-functional Supply Chain Working Group (SCWG)… more
- Eisai, Inc (Nutley, NJ)
- …15 or more years significant clinical pharmaceutical experience (ie, clinical development or operations , regulatory compliance).Substantial experience in ... through cross-functional teams, as well as budget planning & management.Significant project management experience leading multiple critical complex clinical … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities ... Biotech is seeking a Strategic Initiatives & Capacity Expansion Project Manager as part of the Technical Operations...readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionLocation:-Rahway, New JerseyDepartment:-Pharmaceutical Operations and Clinical Supply-Position OverviewJoin us at the forefront of pharmaceutical ... team is following up on assigned actionsServe as the liaison for EDC Operations at non-sterile production tiers, confirming that clinical & development batches… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … project management in cross-functional drug development teams or clinical , regulatory, pharmaceutical sciences/technical operations in the biopharmaceutical ... Manager, Site PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position...OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical … more
- Merck & Co. (Rahway, NJ)
- …depth and breadth of scientific, technical, and operational experience to lead and support facility operations , process development activities, compliance ... drive overall success of the pilot plant. The Facility Lead position reports to the Director of Operations.... Track-record of independent problem-solving. Preferred Experience and Skills: Operations experience in a GMP clinical supply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …based on Business Plans. Cross-Functional Leadership and Communication: Act as a trusted leader , directing QA Strategy and Operations team members. Develop and ... and immune disorders. Job Summary: Director, Global QA Strategy & Operations (Global R&D PV QA) is responsible for providing...promotion of the 6th Mid-Term Strategy for Global QA, lead the execution of the business plan, and manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible ... Operations .Support organizational design updates, operations organization build, operations ramp-up of commercial and clinical capacity.Build strong… more
- Merck & Co. (San Diego, CA)
- …Vice President, Immunology Discovery. This position will serve as Discovery Immunology Project lead on early-stage immunology programs, driving projects from ... and partnering necessary for pharmaceutical development with Translational Medicine, Clinical , CMC, Regulatory, Operations , and other functional areas.Effective… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical ... ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the… more
- Merck & Co. (Durham, NC)
- …achieve project objectives and defined business requirements through exceptional project management. The incumbent will lead cross-functional teams for ... responsible for assessing, leading and managing the successful "end to end"(E2E) project management of major and complex supply chain changes by driving… more
- Insmed Incorporated (San Diego, CA)
- …experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability and experience in the development and execution ... assessments to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations , CMC, QA/QC, Nonclinical,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will ... and risk management. Responsibilities Leadership, Direction, and Strategy: - In collaboration with Clinical Development and Clinical Operations as well as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Facility Support Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Facility Support Manager ... is at an exempt level working within the Technical Operations team. This individual will be responsible for managing facility maintenance activities, including… more
- Merck & Co. (Rahway, NJ)
- …the Company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the ... organization and for the Company's Research & Development division.For our Company Clinical Supply, act as the Quality Unit representative for information technology… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the discovery interface through ... and manufacturing process robustness assessment. - - Primary Responsibilities: - Lead development of new, innovative approaches for product development, generation… more
- BioAgilytix (San Diego, CA)
- …life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of preclinical, clinical , ... while also playing a key role in client engagement, project delivery, and cross-functional collaboration.Essential ResponsibilitiesLead team(s) developing and… more
- Bluestone Physician Services (Stillwater, MN)
- …Overview : We are seeking an experienced and driven Clinical Operations Project Leader to lead and support a range of strategic, operational, and ... Group Home communities throughout Minnesota, Wisconsin and Florida and are supported by clinical operations and administrative colleagues who work remotely or at… more