- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for ... - Leadership, Direction, and Strategy:Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… more
- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands ... the territory for clinical research, finding and developing new-sites.-Participates in internal meetings and workstreams as SME for monitoring processes and-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the ... which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a QSP… 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...you ready to make a difference? The Position The Associate Director, Medical Affairs Omnichannel Engagement, role is to… more
- Merck & Co. (Rahway, NJ)
- …a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director, ... interfacing with the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities include the following:The process/facility… more
- Aequor (Thousand Oaks, CA)
- …Receipt (POR) Temperature Data Review and Assessment: - Review the temperature data from shipments to clinical sites - Assess temperature excursion events ... more of a preference. We can train candidates on our QMTS roles. Associate Supply Chain Description: Candidates will, under limited supervision and in compliance… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and Pharmacometrics - Immune/Oncology team in the role of Associate Director. The team is part of the Global... Director. The team is part of the Global Clinical Development organization and has oversight over drug development… more
- Merck & Co. (Rahway, NJ)
- …requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise. ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug… more
- Aequor (Thousand Oaks, CA)
- …this role: Supply Chain Raw Material Procurement experience or Planning or Master Data . Must have previous buying experience as this role will have buying ... experience preferably in the biotechnology or pharmaceutical industry OR Associate 's degree and 6 years of Life Science or...(ie GxP, SOX) High attention to detail Understanding of clinical study conduct Ability to operate in a team… 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 ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and...IH sampling activities for new or existing equipment. Support data rich experimentation at pilot scale via process analytical… more
- Merck & Co. (North Wales, PA)
- …medical device/combination product documentation to support regulatory filings and audits of data , policies, procedures, and systems to ensure compliance with ... Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Phase 1 studies and multiple dose scenarios, PK/PD M&S analysis data structures and analysis tools requirements, simple disease models, regulatory guidelines ... in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required Experience Qualifications 1+ years Industry… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC ... automation activities throughout the facility.-Primary Responsibilities:Provide process support for clinical manufacturing and R&D processes while also facilitating tech… more
- Aequor (Newbury Park, CA)
- …in Microsoft Suite (Outlook, Word, Excel, PowerPoint) Technical competency for data entry into electronic document management systems , SharePoint sites ... - both oral and written. Ability to understand and communicate scientific/ clinical information, Organizational skills. Knowledge of clinical regulatory… more
- Eisai, Inc (Nutley, NJ)
- …Analytics plus 2 years of work experience in job offered or as Senior Systems Analyst/ Data Analyst/ Associate Projects. Also requires 2 years of experience ... to hear from you.Application Programmer sought by pharmaceutical company in Nutley, NJ.Support clinical applications for clinical data management. Perform … more
- Daiichi Sankyo, Inc. (Louisville, KY)
- …research, academic or US managed markets preferredPrevious experience in Oncology, clinical research and medical education preferred Principal MSL/ Associate ... (eg, Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by… more
- FlexStaff (New York, NY)
- …of care provided and documents same;Performs variance analysis related to outcome data for performance improvement;Designs, implements, and evaluates systems to ... in coordinating and implementing procedures and treatments. Uses leadership skills/ clinical judgment in coordinating patient care and directing/delegating activities… more
