- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership:Has primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross… more
- Genmab (Plainsboro, NJ)
- …to support efficient operations.Forecast demand, manage inventory, and prevent stockouts. Lead cross-functional collaborations, including Clinical Project Supply ... integration management, process and continuous improvement management, digital or data technology, operations, supply chain, manufacturing, ERP, clinical … more
- Insmed Incorporated (San Diego, CA)
- … Research Scientist (CRS) will support and work predominately with the Clinical Trial/Indication Lead (s) and Medical Monitor(s) for assigned protocols and/or ... reporting of results Provide scientific input and review of clinical study data , support in assessing medical...minimum 5 years of drug development experienceExperience with EDC systems (ie, RAVE) and data analysis tools… more
- Genmab (Plainsboro, NJ)
- …with the Global Clinical Drug Supply Planning team. Together with the Global Clinical Drug Supply Systems team, these groups form the Global Clinical ... handling, and cold chain management.Proven experience working with CMOs for clinical trial supplies, including vendor management.Ability to lead cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The role supports all phases of systems development for global informatics systems , ETL and integrations. The Tech Lead must develop and implement ... but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory...15 E- Maintains detailed Solution Architecture diagrams for ALL systems , integrations, and data flows. Work with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform ... to provide complex data review listings and reports to support Data Management and clinical teams. Develop, implement and maintain SAS programming… more
- Merck & Co. (Lower Gwynedd, PA)
- …QbD/DOE principles as well as data analysis and statistics for reporting clinical dataAbility to lead , mentor, and inspire scientists at various levels; ... and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team within the Exploratory Vaccines &… more
- Merck & Co. (North Wales, PA)
- … clinical operations and product quality complaints processes and systems Working Knowledge of Veeva technology productsUnderstanding of regulatory requirements ... that drive IT delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory… more
- Merck & Co. (Rahway, NJ)
- …person for changes to these rules, and evaluation of impact to automation systems with IT driven firewall rule changes. Lead /assist project scopes, define IT ... management of the virtualization system and servers, capital project representation, and increasing systems that send data to an enterprise system (PI).4 years… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … coding process.Working knowledge of MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding tools is a ... - Certified MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience in a medical device,… more
- Merck & Co. (North Wales, PA)
- …strategy, training, and prioritization of Global Plans for USMA.As a core member (or co- lead ) of the US Regional Medical Affairs Team (RMAT), the SDMA partners with ... US Regional Director of Medical Affairs (RDMA) (where applicable), US Global Clinical Trial Organization, Global Medical and Scientific Affairs (GMSA) TA leads, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip ... for ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments and creation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE team. This role will ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...focus on pharmaceutical research Strong knowledge of health care systems in the US, real-world data sources… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ancillary and printing supplies Ensures financial transparency between R&D Finance and clinical operations while maintaining data consistency and accuracy across ... 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)
- …execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate directors. ... the countries, that guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I staff globally in… more
- Merck & Co. (Lower Gwynedd, PA)
- …(eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility ... and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) Vaccines bioanalytical… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …are responsible for: 1) Recruiting and scheduling participants, 2) Conducting clinical and neuropsychological assessments, 3) Analyzing data to assure ... research staff and student volunteers, 5) Using statistical software to analyze data quantitatively and qualitatively, and assisting in the preparation of conference… more
- Lundbeck (Tucson, AZ)
- …transform lives. It's a very exciting time to join our team as we lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager, you ... lead the promotion of our infusion product, driving demand...our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the… more
