- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA ... serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by… more
- 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). ... portfolio, ensuring successful delivery of projects on time, within budget, and meeting quality standards. You will play a critical role in driving the strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... Coordinates clinical activities across the project; Represents IPT to Sr . ManagementAdditional non-study related activities: Provides input on KEE selection for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… 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 ... online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the...in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant… 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 ... this 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Carolinas ContinueCARE Hospital at Pineville (Charlotte, NC)
- Responsibilities:- Develop and implement quality improvement strategies.- Ensure compliance with all regulatory requirements and standards Ensure survey readiness. - ... Medical chart reviews - Manage and supervise the quality assurance team- Conduct audits and assessments to identify areas for improvement- Collaborate with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/Associate Director , External Manufacture as part of the Global ... 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)
- Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing ... various GMP activities supporting the production of clinical supplies with focus on drug product. Additionally, experience in medical device and/or combination… more
- Catalent (Manassas, VA)
- Senior Quality Auditor Position Summary: Catalent...with site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison ... safety of every patient, consumer and Catalent employee. The Senior Quality Auditor will be responsible for...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure) will be responsible for overseeing and facilitating research in ... at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic… more
- Insmed Incorporated (Bridgewater, NJ)
- …the biopharma industry, come to Insmed to accelerate your career. OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional ... strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide....customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and on the market through appropriate epidemiology studies. This Executive Director , the sub-functional lead for Epidemiology group in Global Medical Safety, ... able to provide essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …growth objectives via bespoke, evidence-based M&A advisory services. Reporting into the Senior Medical Director , M&A Scientific Advisory, the Medical Director ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...key M&A focus areas. Relationships Position reports to the Senior Medical Director , M&A Scientific Advisory. Essential… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... focus on uncovering novel biology in immuno-metabolism to deliver a high- quality drug discovery pipeline.We are a research-driven biopharmaceutical company. -Our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD ... Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality...and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality… more
