- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Director, GCTO Project Management Office will report to the Executive Director, Head of the GCTO Project Management Office (PMO). ... and cost control. Monitor project financials and provide regular reports to senior leadership. Risk Management : Identify and mitigate project risks, proactively… 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. (Rahway, NJ)
- …continuity of site relationships through all phases of the trial.Performs clinical study site management /monitoring activities in compliance with ICH-GCP, ... with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.… more
- Catalent (San Diego, CA)
- …and escalation of quality issues to Site Leadership Team and QA senior management .Lead programs for: QA department budget, Site Training, Supplier and ... CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies...the development of site Quality Objectives, site Quality Plans, Quality Management Reviews,… more
- George Washington University (Washington, DC)
- …poisonings, save lives, and limit injury from poisoning.The NCPC is seeking a Senior Poison Center Administrator, Clinical Operations. The incumbent trains and ... affiliated with The George Washington University. In recognition of its high quality , the Center is accredited by America's Poison Centers. The mission 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
- 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
- Carolinas ContinueCARE Hospital at Pineville (Charlotte, NC)
- …to quality assurance- Provide guidance and support to staff regarding quality improvement initiatives- Collaborate with medical management to ensure ... Responsibilities:- Develop and implement quality improvement strategies.- Ensure compliance with all regulatory requirements and standards Ensure survey readiness. -… more
- Integrated Resources, Inc (Atlanta, GA)
- Job Title: Senior Quality Improvement RN Location: 100% Remote Duration: 3-6 months (possibility of extension) Full Remote, must work M-F 8:00 AM to 5:00 PM PST. ... Job Summary: . Client's Quality Management function implements, oversees, and maintains...clinical decision-making. These activities may include initiation and management of interventions (eg, improving patient safety); preparation and… more
- Option Care Health (Tallahassee, FL)
- …communicates with departments across the organization with emphasis on integrating the Quality Management Program into all applicable activities. Oversee and ... and/or time spent)Provides leadership, oversight and support for the organizational-wide Quality Management Programs, including patient safety, risk … 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
- 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management , regulatory agencies, or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/Associate Director, External Manufacture as part of the Global Manufacturing Supply ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… more
- Merck & Co. (Rahway, NJ)
- …collaborate closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success ... Job DescriptionPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation,… more
