- Novo Nordisk Inc. (Plainsboro, NJ)
- …for quality, performance, regulatory compliance, and patient safety related to managing assigned clinical trials, document management and management of ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...start up through closure, including but not limited to: Management of clinical trial documents, including but… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical ... employer including veterans and people with disabilities. Summary The Associate Director, External Data Management ,...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focused approach, leveraging competencies, tools and technology, and with change management skills. Relationships Reports into North American Clinical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… 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 ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Merck & Co. (North Wales, PA)
- …database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Catalent (San Diego, CA)
- Quality Assurance Associate , Clinical SuppliesPosition Summary: Catalent Pharma in San Diego, CA is hiring a Quality Assurance (QA) Associate , Clinical ... level. Use mathematical and scientific reasoning ability to identify aberrant data and potential quality/compliance concerns escalating to management .Excellent… more
- Merck & Co. (North Wales, PA)
- …and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs ... drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders… more
- Merck & Co. (North Wales, PA)
- …the assurance of deliverable quality and process compliance.Familiarity with statistics and clinical data management concepts. Preferred Experience and ... analysis and reporting deliverables for Research & Development (R&D) projects ( data , analyses, tables, graphics, listings). Clinical Data Interchange… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is ... responsible for the management of technology transfer of the manufacturing processes of...transfer, site-to-site technology transfers and PPQ as needed. Conduct data review and analysis, data -driven decision-making process,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …placement and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply ... Operations (shipping, receiving, inventory control, customs clearance, supply / device management ) Responsible to ensure timely availability of clinical study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … across internal and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research ... facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who are primarily responsibility for ... to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent… more
- Merck & Co. (North Wales, PA)
- …SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or ... and according to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the discovery interface through ... development, generation of experimental designs, execution experimental plans and data analysisDrives evaluation of new technologies and leads capability build… more
- Merck & Co. (Rahway, NJ)
- …Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder ... Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global... Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work ... and patient support service providers and organizations. Essential Functions Operational Management & Business Support Support all inline and future launch products… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Engineering Auto Eng position will ... and non-capital improvement projects, and the automation systems spanning various clinical manufacturing facilities. In this role, you will be responsible for… more
