- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , ... of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating… more
- 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
- 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)
- …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)
- …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
- 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
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... , audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality … 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
- 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
- Merck & Co. (Rahway, NJ)
- …new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… 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)
- …and clinical development leadership. Responsible for leading deep scientific and clinical due diligence, the quality of formal due diligence output, ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and Evaluation Job The Search and Evaluation (S&E) team is a core… 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 ... Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality...on continuous improvement to organizational agility. Manages team of senior managers and professionals within Quality . Hires… more
- Merck & Co. (Rahway, NJ)
- …to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with expertise in biopharma research to support our ... to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities for the portfolio of mature brands. Relationships Reports to Executive Director , Mature Business Unit - Head. Interacts frequently in collaboration with ... internal management and senior level managed markets customer representatives. Interacts internally with...including but not limited to KOL development, advisory boards, clinical communications and medical education programs Responsible for the… 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 ... If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …solutions to mitigate or resolve, for example across various topics, such as clinical trial management, deviation handling, and product quality Develop, execute, ... as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites Support local/global quality projects to improve the … more
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