- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review...Program related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior … more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. ... as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and… more
- Catalent (Manassas, VA)
- Senior Quality Auditor Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... safety of every patient, consumer and Catalent employee. The Senior Quality Auditor will be responsible for...quality teams globally during the management of supplier quality issues Lead and support Supplier issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical … more
- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the ... manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit...quality issues to Site Leadership Team and QA senior management. Lead programs for: QA department budget,… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Merck & Co. (Rahway, NJ)
- …design and monitoring of clinical programs and studies, producing high- quality clinical documents and presentations.Collaborate with functional area leaders ... 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… more
- Eisai, Inc (Nutley, NJ)
- …to evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this ... we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to...study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the… 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
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population...in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution:… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director, ... Engineering, Automation Lead position and will be a member of the...production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Merck & Co. (Rahway, NJ)
- …2 years of management responsibility and experience developing staffFluency in the clinical quality management system and CMC process, across modalities and ... a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New...leadership of the FLEx complex is shared across two co- leader roles, and includes operations that support end-to-end GMP… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Senior Manager, US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the ... to and executed by internal business partners and external agenciesPotentially Lead or Co- lead cross-functional project teams involving Marketing, Sales,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Global Team Leader , is a senior , cross-functional leader in Daiichi Sankyo's ... In this key role, the candidate will have to lead a complex, global team in charge of a...a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible… more
- Aequor (Thousand Oaks, CA)
- …for candidates who are the stronger the better, can be a hands off leader , candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal ... or more high-level, complex non-technical projects within the constraints of scope, quality , time, and cost, to deliver specified requirements. Projects may be… more
- Merck & Co. (Rahway, NJ)
- …such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform.-The position will be heavily ... develops colleagues in areas of expertise.- Leads others in a matrix/management environment. Lead the resolution of business practice, Quality and/ or compliance… more
