- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Organization ( CRO ). preferredCRA experience preferredTime spent directly in a medical environment (eg as a Study Site Coordinator) preferredFamiliarity to a ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with some supervision. This position also guides contract research organization ( CRO ) programmers and statisticians in preparing analysis files and performing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... project needs. The position works closely with contract research organization ( CRO ) programmers and statisticians and collaborates with internal programmers in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...Oncology clinical trials. Serves as a primary source of medical accountability and oversight for one or more clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):- Provides oversight to the CRO MM ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...Summary / Objective Serves as a primary source of medical accountability and oversight for one or more clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implementation of sourcing strategies for a specific set of R&D categories ( CRO , Medical Writing, BDM, etc..). Builds strategic plans for specific categories ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... the Clinical Study Teams, Central & Specialty Laboratories, and CROsOversee CRO partner sample management activities per study level including sample tracking,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO , Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills… more
- Merck & Co. (Rahway, NJ)
- …to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human ... projects.Interacts with Academic Research Organization (ARO), Contract Research Organization ( CRO ) and external statistical consultants.The incumbent may initially work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... she will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program. Other responsibilities… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- BioAgilytix (San Diego, CA)
- …Preferred QualificationsEducation: Bachelor's degree in biology, chemistry, biochemistry, medical technology, or other scientific discipline Not less than ... GLP/GCLP/GMP quality assurance (QA) Experience working in biotech, pharmaceutical, CRO /CMO or similar organizationSkills: Internal and/or external GxP auditing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx assays and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with stakeholders to ensure a compliant ready state of operation.Ensure that CRO / Vendor quality events/ incidences are adequately reviewed and CAPAs followed up… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... departments within the Company. Also communicates with outside consultants (ie CRO 's) as needed. Qualifications: Successful candidates will be able to meet… more
- Merck & Co. (North Wales, PA)
- …to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human ... activities for clinical drug/vaccine projects. May interact with Contract Research Organization ( CRO ).This position may serve as a statistical lead in project teams.… more
