- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner ... on assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is...a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Manager of External Brand & Content Strategy will be instrumental in shaping ... from ideation and drafting through editing and production. Develop strategic, high- quality content across multiple formats (written, audio, video). Top priority work… more
- Merck & Co. (Rahway, NJ)
- …evaluate existing workflows, and implement best practices to improve the quality , accuracy, and speed of regulatory operations activities. Perform regulatory tasks ... management certifications (eg, PMP, PRINCE2) preferred.Experience as a project manager preferred.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Rahway, NJ)
- …and analyzing system and passive data governance reports to ensure high quality data and timely and complete synchronization between systems. Acts to resolve ... preparation and overall accounting knowledge. Thorough understanding of data manager packages. Strong understanding of Enterprise Process Management to troubleshoot… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology department of the Global Precision Medicine function. The Manager , CDx Diagnostics Scientist's primary responsibilities are:Assists in defining the ... Laboratories and Clinical CROs for the timely deployment of high- quality biomarkers analysis on clinical samples.Responsibilities:Supports the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations ... with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... and maintaining new SOPs, Work instructions, templates, and other quality documents.Responsibilities:Leadership, Direction, and Strategy: Establish and manage accountability… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …global markets are also met.Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the ... dealing with contract manufacturing organizationsMust have solid understanding of quality management and continuous process improvement principles including global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors colleagues on the outsourcing process and procedures. (not ... a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development and management of other ad hoc special projects as they… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance ... to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.Vendor Management -supports Person… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Accounting at Novo Nordisk Inc. As part of the NNI Finance team, the manager will business partner with budget controllers (FP&A) and other key stakeholders across ... what it takes mindset and positive attitude Commitment to Quality - dedicated to providing the highest quality... Quality - dedicated to providing the highest quality services to internal and external customers; demonstrates attention… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance ... Manager role is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring that all stakeholders are aligned and informed. Ultimately, the Content Project Manager plays a critical role in delivering high- quality digital content ... A WEEK, IN OFFICE IS REQUIRED The Position The purpose of the Content Project Manager role is to oversee and manage the execution of content projects from strategy… more
- Genmab (Plainsboro, NJ)
- …Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical ... Drug Supply Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In… more
