- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will provide knowledge-based coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally ... Clinical Development to collate the necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …request; manage interactions with Vendor, finalize, and execute amendment.Audit Ready/Inspection Prep : As per the audit requirement and processes, storage of ... appropriate information and follow up directly with individuals to close any gaps. To prepare for an Audit/Inspection, the first step is to create a Vendor List for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate training (ie compliance, workshop training, facilitation skills, etc) and are prepared to deliver the materials.Will be required to partner with Senior ... appropriate training (ie compliance, workshop training, facilitation skills, etc) and are prepared to deliver the materials.Will be required to partner with Senior… more
- Eisai, Inc (Boston, MA)
- …(NLP) techniques to generate insightful infographics and actionable data-driven insights.Data Preparation for Analysis: Prepare data for modeling by cleaning ... Proactively propose alternative solutions to optimize business outcomes.AI-Driven Data Preparation : Skilled in utilizing AI and machine learning techniques for… more
- Repligen (Waltham, MA)
- …departments and building strong relationships with stakeholders.ResponsibilitiesSEC ReportingLead the preparation and filing of all SEC documents, including 10-K, ... with the legal, investor relations, and senior finance teams to prepare and review quarterly earnings releases and related disclosures.Research and implement… more
- Twist BioScience (South San Francisco, CA)
- …biology protocols, cell culture, fermentation, purification, aseptic filling, media/buffer prep , etc.) and associated automation/control systems (SCADA, DCS, PLC, ... HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for custom-built systems.Experience with system integration (eg, ERP, LIMS, QMS) using APIs, web services, or other… more
- BioAgilytix (Durham, NC)
- …scientistsAbility to assist with definition of project scope and proposal preparation (SME) Prepare and review scientific training materialsSet up studies ... project needsMay serve as principal investigator on a projectMay prepare and submit deviationsManage project timelines/schedulingManage budget and revenue for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …insights and deliver concise updates on project statuses and next steps to prepare the Head of Late Stage Oncology Development for upcoming discussions, commitments, ... and meetings; Prepare presentation documents, speaker notes and memos for meetings,...Late-Stage Development in management of budget, capacity, resources and preparation of associated reportsPrepare communications on behalf of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, ... (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Ensuring efficient travel arrangements are made. Ensures the President is sufficiently prepared for all meetings Works closely with and assists President on various ... expat related & personal matters. Provides information as required. Handles all matters with the utmost discretion Executive Meeting Management Addresses and manages a schedule with a high level of prioritization, analyzes schedules, resolves conflicts and… more
- Merck & Co. (Sacramento, CA)
- …effectively meet project timelines and deliverables.Ensure our external testing sites are prepared for inspections from multiple agencies (ie FDA, EMA, PMDA) from an ... analytical technical perspectiveAuthoring and/or reviewing technical documents to support Process Performance Qualification (PPQ), licensure and regulatory technical questions. SKILLS REQUIRED Minimum Education Required and Experience: Bachelor's Degree… more
- Merck & Co. (Millsboro, DE)
- …to approved procedures Assist with performing aseptic procedures including media preparation , antigen inoculation and harvest, tissue culture preparation and ... Process, Manufacturing Documentation, Manufacturing Operations, Manufacturing Quality Control, Media Preparation , Process Improvements, Regulatory Compliance {+ 5 more}-Preferred Skills:Job… more
- Eisai, Inc (Mckinney, TX)
- …requested.Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr. ... MSL activities, as required and assigned by the management.Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs.Develop, implement and present to management plans to support Medical Affairs strategic direction for… more
- Aequor (Fort Worth, TX)
- …(Cataract, Vit) sales and placements and Generic ASC rebate agreement preparation , calculation & payment. This includes in-depth portfolio analysis and results ... Assist Surgical Sales Force in the timely and accurate negotiation and preparation of various financing contracts. Ensure pricing is within guidelines and that… more
- Pratt & Whitney (Clayville, NY)
- …set up and sample preparationTroubleshoot all issues associated with sample prep , establish training plans and verify training effectivenessPlans and verifies ... training effectiveness Perform analysis on a wide variety of materials where methods and techniques have been established, and assist in establishing methods or techniques when required Accept or reject material based on specificationsOrganize, report, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the requirements and functions of the job of the date this description was prepared . It is a general guideline for managers and colleagues, but it does not ... purport to be an exhaustive list of all the elements of the job. Management reserves the right on a temporary or indefinite basis to change or adjust job requirements to meet business, scheduling and staffing needs. Daiichi Sankyo, Inc. is an equal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) ... and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose ... mitigation plans. CRO and Quality Oversight:Responsible for oversight of all CROs utilized within their therapeutic area. May represent Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure… more
- Eisai, Inc (Exton, PA)
- …suites in a cGMP biopharmaceutical pilot plant, including scheduling of staff, preparation and close-out of documentation, manufacture of DS/ADI materials, and suite ... production schedules. Be responsible for the scheduling of staff and facility, preparation and close-out of documentation, and maintenance of the facility and… more
- Twist BioScience (South San Francisco, CA)
- …improve, and troubleshoot our latest genomics/NGS products, ranging from library preparation kits, enrichment reagents, synthetic controls, and beyond. In this ... is requiredExpert understanding of molecular biology techniques including library preparation , molecular cloning, DNA modifications, DNA amplification/purification, Target Enrichment,… more
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