- 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 ... exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control laboratories in support of both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...QA processes and quality standards for continuous improvement and operations excellence. This may include the review of business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL ... and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position will assist in supporting several areas within Legal Operations , including but not limited to; Contract Management, Program and Grants ... regarding actions to be taken on each request, communicate with counsel and compliance on a regular basis. Communicate daily with colleagues of PGC to assist… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Manager role supports Government Pricing, Contracting Compliance , State Price ... FCP/FSS, IFF, and URA) and rebates for Federal Drug Programs in compliance with Genmab's methodologies and standard operating procedures.Oversee the analysis and… 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 ... Data Management Data Operations team and serves both as a subject matter...of identified access discrepancies per study to maintain overall compliance and inspection readiness of the application. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …which include API and drug product manufacturing, packaging and labelling operations , QC testing and release, and distribution for biologics and small-molecules ... Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …master batch records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, ... Legend Biotech is seeking Operations Supervisor as part of the Technical ...individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.Work closely with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , Cleaning ... SciencesMinimum 5 years of experience in Technical, Engineering, and/or Operations in a GMP production environmentExperience conducting, supporting, reviewing and… 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 ... to clinical supply planning and incorporate them into the team's operations . Focus on Customers and PatientsMake rapid, disciplined decisionsDemonstrates ethics 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 ... matter expertise- - Knowledge of order management, supply chain operations and document control - GCSCareer#eligibleforERPPSCSGCSCareer25VETJOBSCurrent Employees apply HERE… more
- Tris Pharma (Monmouth Junction, NJ)
- …Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures ... New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ,...systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to… 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 ... will focus on maintaining House in Order by ensuring compliance with Sarbanes Oxley and Novo Nordisk Corporate Accounting...Inc. As part of the NNI Finance team, the manager will business partner with budget controllers (FP&A) and… 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 ... Access), Brand Marketing, Training, Market Access & Public Affairs, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to… more
- Genmab (Plainsboro, NJ)
- …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 ... influence over the refinement of Genmab's processes, both within the GCDS Operations team and cross-functionally to ensure scalability.It is expected that you will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as IT Security Architect for assigned services. Relationships Reports to the Senior Manager - Global Security Operations - Americas. Will support the Advanced ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team ... to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global Clinical Drug Supply Project/Trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …policy compliance regarding the Master Data Domain Works closely with Sr. Manager - Data Management Operations to support, communicate and build transition ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ... on new procedures, to auditing against local and corporate policies, to reporting compliance -related issues, ECP keeps us accountable every step of the way as we… more
