- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior … more
- Merck & Co. (North Wales, PA)
- …in collaboration with Data Management /Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of ... and presentation skillsEducation/Experience: Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management , and/or medical field… more
- Merck & Co. (Rahway, NJ)
- …this valuable insight, you will provide feedback to senior management and drive continuous improvement initiatives. Quality Improvement Champion:-Act as an ... Job DescriptionJoin our team as a Clinical Quality Operations Lead - Inspection...inspections. Your expertise and guidance will ensure the smooth management , training, and support of regulatory Health Authority inspections,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Manager, Operations and Reference Data Management , Global Clinical Data Standards Working closely with the Global ... and provide insights into implementation of strategic direction.In support of the Senior Director, Operations and Reference Data Management , ensures project… more
- Merck & Co. (Rahway, NJ)
- …standalone, laboratory instrument systems and manufacturing automation systems.Endorse and build Quality Management System elements into the end-to-end computer ... organization and for the company's R&D division.For company's Clinical Supply, act as the Quality Unit...and testing.Act as a liaison with respect to the Quality Management System and Compliance pillars of… more
- Catalent (Manassas, VA)
- Senior Quality Auditor Position Summary: Catalent...approval Act as a liaison between suppliers and the quality teams globally during the management of ... safety of every patient, consumer and Catalent employee. The Senior Quality Auditor will be responsible for...be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are… more
- Eisai, Inc (Nutley, NJ)
- …Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides statistical and ... we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… 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
- 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. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management… 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 ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ;… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead...the compounds' life cycle management , with support from management as needed.… more
- Merck & Co. (Rahway, NJ)
- …a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will ... Quality SystemsExperience in supporting compliance investigations and change management .Familiarity with US and EU GMP and Safety compliance regulationsEffective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …design, operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management Drives and leads the successful ... components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people … more
- Eisai, Inc (Nutley, NJ)
- …business decisions. Can apply financial analysis to build business cases that drive quality decision making and management processes.Travel is estimated at 30% ... this is your profile, we want to hear from you. Senior Manager, US Alzheimer's Strategy and Lifecycle Planning Marketing...and logistics associated with the congress experience.Assist with the management of the brand plan dynamic dashboard to drive… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… 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)
- …top end of the experience level. Ideally candidates who have strong project management experience as well as product development experience (Have skills such as lean ... better, can be a hands off leader, candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal candidate possess that will work well with the… more
