- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset ... and quality. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning, review Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review, review analysis dataset ... submission strategy, perform integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission QAs, perform ad-hoc… more
- Taiho Oncology (FL)
- …personnel. Medical Affairs personnel. In collaboration with Medical Affairs personnel support data generation Investigator-Initiated Trials (IITs) and HCP ... Department with a primary responsibility to engage in the exchange of scientific data , education of health care practitioners on Taiho products and relevant disease… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... any required documents to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs. Develop and maintain positive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high standards of ... data quality and compliance within Global R&D & PV...stakeholders (RD, PV and MA) to drive timelines and report on key deliverables related to quality and compliance.… more
- Merck & Co. (Rahway, NJ)
- …operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities, preferably with experience in new ... functional potency assay technologies, such as cell line engineering to build reporter gene assays, cytotoxicity assays.- Expertise in binding assays such as… more
- Raytheon (Tucson, AZ)
- …with formal testing, which may include Test Readiness Review (TRR) and Test Data Review (TDR) packages. Support field testing and occasional travel for durations ... laboratory testing events, and the associated analysis of test data . This position is an onsite role in Tucson...aircraft in the field and provide test plans and report writing at home station.Make cost and schedule decisions… more
- BioAgilytix (Durham, NC)
- … data -driven decision-making across BioAgilytix, by leveraging enterprise systems and data visualization tools to report critical business information. This ... role is responsible for gathering and integrating data to provide actionable insights that support sales operational efficiencies, commercial initiatives, and… more
- Merck & Co. (Rahway, NJ)
- …This role requires excellent analytical, negotiation and communication skills.This role will report directly to the Chief of Staff to the General Counsel & ... leading RFP projects, managing timelines, preparing reports and analyzing data , creating presentations, and coordinating deliverables. Respond to inquiries from… more
- Merck & Co. (Rahway, NJ)
- …monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position ... Ambition - Respect - Inclusion.Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Primary responsibilities include validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and ... in the pharmaceutical or biotechnology industry Experience preparing protocols, executing data analysis, and report writing Experience preparing protocols,… more
- Merck & Co. (Rahway, NJ)
- … manager packages. Strong understanding of Enterprise Process Management to troubleshoot report /input templates (in cases of master data or other validations) ... And will also provide operations solutions reviewing and analyzing system and passive data governance reports to ensure high quality data and timely and… more
- Aequor (Framingham, MA)
- …and pilot-scale projects, including regular team meetings and updates for, data management, investigations, technical report writing, and regulatory filings. ... (eg, Client Healthcare AKTA). Authoring and executing protocols, interpretation of data , and report generation. Operating and troubleshooting process equipment. more
- Merck & Co. (Boston, MA)
- …(RaDS) value team in R&D IT brings together product management, engineering, and data science expertise. We enable data , technology and services that accelerate ... to join the RaDS Product organization. The position will report to the-Lead of the Disease Biology and PharmTox...partner closely with key business stakeholders, the product, engineering, data science and other IT teams, to leverage advanced… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: The selected candidate will provide procurement support for Clinical Development Sourcing and Procurement (CDSP) in C linical ... negotiating costs, executing contracts and ongoing contract management. This role will report to the Associate Director, Clinical Trial Central Labs to support… more
- Genmab (NJ)
- …and study-related materialsDevelop and maintain the study TMF PlanClinical Study Report (CSR) Management: Support filing appendices of Clinical Study ... 3-5 years in clinical trial operations.Experience in coordination and support activities for clinical trial conduct.Experience maintaining and tracking critical… more
- Eisai, Inc (Mckinney, TX)
- …with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers (healthcare ... and participation in strategic thinking.. Essential Functions Product/Therapeutic Area Support to External Stakeholders Act as the primary clinical/scientific… more
- Tris Pharma (Monmouth Junction, NJ)
- …other, and we believe in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris has ... to Net Analyst - BrandSUMMARY:The Revenue/Gross-to-Net Analyst - Brand provides operational support to the Finance team by leading the Brand Gross to Net… more
- Genmab (NJ)
- …Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust ... country and site identification, support of DEI (as applicable), recruitment projections, and any...stages of global feasibility. Ensure standardization in use of data , tools and processes to inform risk-benefit decision making… 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 ... and MASH programs, ensuring market/product/organizational readiness. Relationships This position will report to the VP of Future Portfolio, Pipeline Strategy and… more
