- 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)
- …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
- 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)
- …seeking a highly motivated candidate to join our team as a Pilot-Scale Operations Lab Manager . This role involves managing, organizing, and providing support ... to the laboratory areas within our pilot-scale lab operations team. The position offers an excellent opportunity for growth and development in a professional lab… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and compliance with ... and assures proper documentation of complaints and timely investigation and operation . Supports the receipt, logging, and assignment of complaint investigations for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Disbursement operations , processes and strategies as a shared services operation , meeting all deadlines and related responsibilities in support of the enterprise ... of Financial Disbursements, that manages the day-to-day Financial Disbursement operations (Accounts Payable Processing, Travel and Expense Reimbursement and… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure ... around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global Quality departments… 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 ... with vendors to define and manage service-level agreements (SLAs), ensuring compliance and high-quality service delivery- Monitor vendor performance, conduct regular… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… 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
- Merck & Co. (Rahway, NJ)
- …and International Conference on Harmonization Good Clinical Practice (ICH GCP.)As line manager , the role is critical to continuously develop key talents by providing ... of the country capabilities. The role will collaborate with country Partner Line Manager 's ( PLMs) to ensure alignment across all monitoring functions. The person… 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
- Aequor (New York, NY)
- …drives growth by supporting all lines in GCS with business planning, operations & external engagement activities. The optimization of all these elements internally ... several key accountabilities: Act as an interface between internal operations and high touch external suppliers to drive the...use of systems and data analysis, to ensure business operation information is delivered in a timely manner aligned… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be ... to existing GCO procedural document packages.As needed, monitor 1) procedural compliance metrics to support inspection readiness activities, and 2) procedural… more
