- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and ... objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role,...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... to department repositoryCoordination of collection, international shipment, processing by internal/ external labs and data transfer for biospecimen- based studiesParticipate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... procurement activities.- Contract Management for contracts requiring internal approval and/or external approval (CMO, requests over $100k) is required. A full… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, ... Services, Senior Leadership, etc.) on deviations and PQC investigations relating to production operations , quality operations oversight and quality … more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... define priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing… more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's DSCS Digital… more
- Merck & Co. (Rahway, NJ)
- …CRA manager and/or functional vendor and internal management as-needed.Performs Quality control visits as required.Leads local study teams to high performance: ... Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end performance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, ... to Clinical Operations on site issues. Contributes to development of CSR. External collaboration: Consults with internal experts and external KOLs for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This position reports to the Director - Accelerated Efficiencies and Optimization, Strategic Operations . The Project Manager regularly works with members of CMR ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of… more
- Insmed Incorporated (San Diego, CA)
- …as quality initiatives and therapeutic area training (TAT).Oversees daily operations in the laboratory with respect to troubleshooting instrumentation, out of ... unit to ensure efficient and effective scientific and administrative operations . Operates, maintains, and repairs clinical laboratory equipment within scope… more
- Merck & Co. (Rahway, NJ)
- …with strict adherence to local regulations, company SOPs and ICH GCP.As line manager the role is critical to continuously develop key talents by providing training, ... continuous development.Ensures CRA compliance to corporate policies, procedures and quality standardsExtent of Travel:up to 50%Qualifications, Skills & Experience:CORE… more
- Aequor (Thousand Oaks, CA)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... contracting negotiations and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
- Merck & Co. (Durham, NC)
- …Required Experience and Skills: Minimum 2 years of experience in pharmaceutical operations , technical services, and/or quality operations . Preferred ... grasping pushing and pullingAbility to travel WORKING RELATIONSHIPS: Reports to Quality Manager Interacts with employees within own department Frequent… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...initiatives related to supply chain assets, workflow processes and operations . The ability to work efficiently and partner with… more
- Merck & Co. (North Wales, PA)
- …and Key Opinion Leaders.Coordinate confidentiality, consultant agreements and external engagement meetings.Participate in quality control and ... exchange, improving access and health outcomes for patients. The Research Management Operations team sits within the Real-World Evidence (RWE) Operations … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... effort will have a focus related to industry available cell therapy unit operations to be incorporated with an automation platform that integrates with MES systems… more
- Insmed Incorporated (Bridgewater, NJ)
- …of raw materials, components and services consistent with specified levels of quality , delivery, price and total cost. This position will support the Associate ... Director, Supply Chain & Logistics in managing a network of external manufacturers, maintain plan/schedules, conduct supplier meetings and managing inventory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batch records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor (2nd shift) as part of the Technical Operations team… more
- Lundbeck (Chicago, IL)
- …other areas of the business; ie, marketing, sales training, managed care account manager , sales operations , account management is a plus. Previous sales ... on our journey of growth! As an Area Sales Manager (ASM) you will be responsible for leading, developing,...to discover and meet the needs of internal and external customers by building relationships and delivering innovative solutions.… more
