- Deloitte (Jersey City, NJ)
- …program and target operating model, data strategy & governance, risk & control framework, content definition & standardization, training and end user enablement ... for optimization + Working collaboratively with senior risk stakeholders (CIO, CRO , CISOs and direct reports) + Building solid, trust-based relationships with… more
- Grifols Shared Services North America, Inc (Toms River, NJ)
- …and treatment questions in collaboration with the contract research organization ( CRO ) medical monitor, or directly with study investigators + Work closely ... with preclinical scientists to understand how the biological effects observed in animals can be translated to humans, and use this information to choose the best clinical endpoints and biomarkers for clinical trials + Be familiar with the nonclinical safety… more
- Sanofi Group (Morristown, NJ)
- …3 or phase 4 studies, in an industry setting (ie. pharma, biotech, CRO ) **Knowledge and Skills** + Thorough and up-to-date knowledge of statistical methods, ... especially those related to human clinical studies + Thorough and up-to-date working knowledge of SAS with hands-on programming experience. Knowledge of S-PLUS or R is a plus + Working knowledge of SDTM and ADaM data structure and CDISC standards + Working… more
- System One (Trenton, NJ)
- …company Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO 's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ... ensure all needs are met. * Working with teams for optimal use of the investigational material supply chain to achieve study and corporate goals. * Identifying and supporting strategies for continuous improvement and departmental and/or inter-departmental… more
- Actalent (Basking Ridge, NJ)
- …study protocols and amendments, and lead document review and coordination. + Oversee CRO and vendor selection, scope of work creation, and ensure compliance with ... quality measures and timelines. + Monitor clinical trial performance and quality metrics, escalating issues and proposing solutions as necessary. + Ensure study adherence to internal procedures for planning, conduct, close out, and reporting. + Monitor and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …RBQM and/or related work experience in pharmaceutical company, Biotech, or similar environment (eg, CRO ). required - 5 or more years managing people required - 5 or ... more years managing projects required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion,… more
- Merck (Rahway, NJ)
- …trends in commercial production space + Experience working with CMO's and CRO 's **Preferred Experience and Skills:** + Working knowledge of pharmaceutical drug ... substance and/or drug product development and commercialization + Working knowledge of CMC filing requirements and regulatory guidances (eg, ICH) for drug substance and/or drug product + Experience supporting regulatory inspections and internal audits as… more
- Merck (Rahway, NJ)
- …of API development and commercialization + Experience working with CMO's and CRO 's **Preferred Experience and Skills:** + Technical experience that includes LC-MS, ... GC-MS and/or ICP-MS. + Working knowledge of CMC filing requirements and regulatory guidance's ( _e.g._ , ICH) for API + Demonstration of working in cross-functional team + Strong interpersonal skills including the ability and sensitivity to deal with different… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc. + Review development of site and CRA training ... materials and presentation at SIV and Investigator meetings and support on Study committee (eg, DMC) activities + Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (eg, IB, DSUR, regulatory responses)… more
- Dodge Construction Network (Trenton, NJ)
- …website performance: Drive conversion strategy and Conversion Rate Optimization ( CRO ) across company-managed websites and landing pages, including primary ownership ... of Construction.com + Act as the key liaison with internal engineering and/or external development partners to scope, prioritize, and implement website enhancements or technical changes + Oversee content performance: Collaborate with the Director of Content to… more