- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director, Global Strategy & Investigations Owner/ Lead as part of the Technical ... MSAT organization leadership team. This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory ... on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in...regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Development Operations (GDO) ( Global Clinical Operations / Clinical Quality Management or other RD business process owners that applicable clinical ... well as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and enable visibility across regions and sub-functionsPartner with the Process Excellence Lead and others to identify… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be ... Area strategy that will bring forth programs to successful approval and registration. Lead late-stage development for our company's assets in this TA by overseeing… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- HKA Enterprises (Columbus, OH)
- …in vulnerability management using SAST and dependency management tools.Ability to lead a small team of security engineers responsible for vulnerability remediation ... application maintenance. Release / SCM Management: Supports the DevOps release management process in an agile and rapidly changing environment. Fosters the execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored ... and Medical Access/Expanded Access Program (MAP)/(EAP)Support the oversight of the overall global oncology review process of PhIV company sponsored studies per… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred- Relevant ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...clinical trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …your career. Are you ready to realize your potential? The Position The Deviation Leader /Coordinator is responsible for the quality and oversight of the deviation ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...global leadership We commit to an inclusive recruitment process and equality of opportunity for all our job… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For Phase 2 ... PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …such actions. Participate in cross-functional teams responsible for regional and global process improvements in the operational efficiency of PJ ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... around rare diseases and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner ... and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer... global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit… more
- Catalent (Manassas, VA)
- …suppliers in compliance with Global procedures and Regulatory requirements Generate Global Quality Agreements in accordance with templates and liaise with ... Quality Auditor Position Summary: Catalent is a global , high-growth, public company, and a leading partner for...quality teams globally during the management of supplier quality issues Lead and support Supplier issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the ... teams on RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CSO Continuous Improvement function to establish industry-leading label development process that incorporates global regulatory requirements while incorporating ... leading process improvements designed to reduce cycle times, improve Quality and decrease costs. Qualifications: Successful candidates will be able to meet… more
- Catalent (Philadelphia, PA)
- …array of categoriesCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over ... Quality Assurance Document Control Position Summary Catalent Pharma...position: Monday - Friday, 1st shift. Catalent is a global , high-growth, public company and a leading partner for… more
- Merck & Co. (Rahway, NJ)
- …drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the ... SAP Platform Team is responsible for our company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business...the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all… more
- Russell Tobin & Associates (Dublin, OH)
- …firm, with additional offerings in vendor management, payroll programs, and business process optimization. BENEFITS DISCLOSURE Pride Global and its affiliates - ... the Transportation Project Manager for the Great Lakes, this candidate will lead roadway expansion and improvement projects within the transportation team across the… more
