- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... (IR) and pre-approval Inspection preparation activities for global clinical operations , responsible for representing the GCO-CQM inspection readiness within the… more
- Merck & Co. (Durham, NC)
- …supply to customers and patients on time, every time, across the globe.The Manager , Quality Operations (QO) Microbiology will be responsible for leading and ... supplements and new product license registrationsCollaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirementsInfluence, motivate, and… more
- Merck & Co. (Durham, NC)
- …the last several years; currently Durham employs 1,000+ people.This role as a Manager , Operations will be an energetic, leader with strong interpersonal, ... based on business unit needs during start up and operations , and specific assignments.This position is for days reporting...- that impact the efficiency and effectiveness of own unit; Compliance - Responsible for creating and sustaining a culture… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based ... in Raritan. Role Overview The Warehouse Operations Manager will work within Technical ...as per Legend Biotech policies and GXP requirements. Ensure compliance of operational activities with GXP, quality, training, EHS,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trends, and variances to ensure acceptable business practices, procedures and compliance have been followed.- Contract Management/ Finance Liaison/ Internal Audit ... service disruption is required.- Strategic Planning- Under the guidance of the Manager develop and implement business operational strategies that align with the… more
- Merck & Co. (Rahway, NJ)
- …and project management for assigned protocols in a country in compliance with-ICH/GCP and country regulations, our Company policies and procedures, quality ... Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned… more
- Merck & Co. (Rahway, NJ)
- …performance and project management for-assigned protocols in a country in compliance with ICH/GCP and country regulations,-our company's policies and procedures, ... Point of Contact (POC) for assigned protocols and link between Country Operations -and clinical trial team (CTT).- Responsible for project management of the assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations . This position develops SAE Flow Plans and electronic data capture (EDC) ... 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
- Eisai, Inc (Nutley, NJ)
- …relevant security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution ... review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creativity and foresight needed for continuous improvement and efficiency in payroll operations . This role is integral to the efficient operation of the ... organization's payroll function, ensuring both accuracy and compliance in all aspects. This role is expected to play a key role, acting as single point of contact,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver upon near & mid-term NACO ... studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually… more
- Merck & Co. (Durham, NC)
- …and embraces an inclusive team culture including significant interaction with Operations , Quality, Automation, Technology, and other groups as required. Primary ... Controllers (PLC), robotics)Maintenance Equipment (eg tools and calibration equipment) Compliance : Ensure that maintenance activities are executed in compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... and outside of the organization Demonstrates knowledge of internal business operations and applies this knowledge to analyses, processes and deliverables Manages… 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 / Sr. Operations Supervisor (2nd shift) as part of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the financial management and budget development of North America Clinical Operations (NACO). Responsible for driving financial oversight across trial portfolios to ... from draft protocol through trial closure for North America Clinical Operations (NACO) Manages and communicates financial status of ongoing clinical trials,… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …entire Market Access & Public Affairs Team, PCOR (Pricing, Contracting, Operations and Reimbursement), Marketing, Area Commercial Sales Team, Medical Affairs, Legal ... & Compliance and Human Resources. External relationships include responsibility for...in business-relevant field preferred Previous experience as a people manager preferred At least 5 years pharmaceutical/biotech / healthcare… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …the Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance , will oversee end-to-end contract ... management for the Institute and manage daily operations for all federal contracts and compliance ... of the Office of Research Contracts (ORC).The Contracts Manager - Federal Contracts and Compliance will… more
- Aequor (Seattle, WA)
- Job Description: Position: Technical Project Manager Location: Seattle WA Top Skills: 5&plus years' experience in bio tech/life sciences project management; cell ... CMC drug development. Familiarity with alliance management Job Description The Technical Project Manager (PM) will be a key member of the Cell Therapy Development… more
