- Daiichi Sankyo, Inc. (Bernards, NJ)
- …information, letter of authorization, etc.) for US regulatory submissions.Support FDA meeting preparation including preparation of briefing document , meeting ... request, response to FDA preliminary comments and logistics.Support FDA meeting preparation including preparation of briefing document , meeting request,… more
- Merck & Co. (Rahway, NJ)
- …to enhance the overall learner journey.Responsibilities Facilitate meetings and document meeting outcomes, ensuring that action items are accurately recorded ... execute processes/ activities necessary for ensuring the success of the product. Prepared to be adaptable and maintain an open-minded approach towards changes and… more
- Aequor (Bothell, WA)
- …usage of TFF systems, Nucleic Counters, Mixer, Filler, FIT, Veeva Document Management System, Infinity, ServiceNow, and emerging technology is preferred.Ability to ... and Lab/Clean room environments, PPE required at times.Physical Demands:Ability to move computers and monitors from prep room to labs, lifting up to 25lbs. more
- Eclaro (Research Triangle Park, NC)
- Sample Prep & Logistics Assistant Job Number: 24-02847 Join the ECLARO Team! ECLARO is looking for a Sample Prep & Logistics Assistant for our client in Research ... Exceptional attention to detail and problem-solving skills. Ability to document activities accurately and responsibly. Excellent verbal and written communication… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assessment, and CAPA/EC determination.Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, ... consistent with Quality risk management principles.Must be able to effectively prepare communications with interpretation of data analysis and potential problems to… more
- Merck & Co. (North Wales, PA)
- …and guidance.- The Principal Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. ... the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead development and execution of detailed,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …messages, and review and author safety sections of Common Technical Document (CTD). May oversee multiple simultaneous submissions to ensure harmonized approach ... messages, and review and author safety sections of Common Technical Document (CTD). May oversee multiple simultaneous submissions to ensure harmonized approach… more
- Eisai, Inc (Nutley, NJ)
- …with creating, updating and maintaining project trackers in EPIC Provides support for document preparation and follow-up ( eg Informed Consent Form, eTMF fling ... plan, Co-Monitoring Plan) Creates Clinical Trial Agreement requests using the legal tracker and follows-up on original agreements and amendments. Upload to Epic site Coordinates reviews for essential materials such as ICFs and Co-monitoring plans CRO and… more
- Merck & Co. (Durham, NC)
- …responsibility include but are not limited to activities of: Media Preparation , Fermentation, Tangential Flow Filtration, Process Monitoring, Sampling, and area ... to maintain own training status and ability to train others.Participate in document design activities working alongside operations team members to develop reliable,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …concepts Proficiency in data cleaning, feature engineering, and data normalization to prepare the data for model training. Understanding of statistical methods and ... of the project and system development methodologies Excellent technical writing, document organization, technical document review and analytical thinking skills… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and existing functionality. Responsible for the development of the Technical Design Document to ensure all requirements have been met. Responsible for reviewing unit ... refine and prioritize business requirements. Assist in the technical preparation of Business Process Procedures, functional specifications, test scenarios, end-user… more
- Genmab (Plainsboro, NJ)
- …Treasury, Tax, Internal Audit, External Audit and other functions within FP&A. Prepare partner settlement invoice posting by working with cross functional teams ... due dates internally and externally to prevent negative impact on cash flows. Prepare ad hoc analysis to assist Senior Director with actuals and forecasting… more
- Merck & Co. (North Wales, PA)
- …with FDA at all phases of drug development.Leads cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.Coordinates ... advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label… more
- Davron LLC (Traverse City, MI)
- …in early project phases, including structural methodology and load determination Prepare detailed drawings and specifications for permitting and construction Ensure ... and ensure compliance Evaluate existing structures, perform necessary testing, and document findings Maintain thorough records for future reference and reporting… more
- CHRISTUS Health (Irving, TX)
- …service line and assist in developing data pathways for complete QAPI preparation and presentation. Develop and implement effective written mechanisms to document ... and implement effective tools to measure performance against these standards and to document and regularly report on the status of projects and routine assignments.… more
- CHRISTUS Health (Beeville, TX)
- …to our soon-to-be moms, laboring moms, delivering moms and new moms, and help them prepare for the most exciting experience of being a new mom or new parents. As ... between various stations or units Discusses the functions, features and document flow of electronic documentation Transcribes verbal orders; explains techniques for… more
- CHRISTUS Health (Leon Valley, TX)
- …the patient while waiting to be registered or seen by the provider. Document in the computer system all necessary demographic, insurance, and financial information. ... of facility, exam rooms and instrumentation per practice and OSHA policies. Prepare exam rooms with necessary instruments. Order supplies per clinical standards. … more
- HO PENN (Stewart Manor, NY)
- …be computer proficient to be able to run diagnostic software and prepare service communications Must have strong communication and self-management skills Must be ... problems Troubleshoot mechanical problems Efficiently utilize resources to correct problems Document steps taken to correct problems Maximize the efficient use of… more
- HO PENN (Ozone Park, NY)
- …Must be computer proficient to be able to run diagnostic software and prepare service communications Must have excellent verbal and written communication skills Must ... superior value Troubleshoot problems Efficiently utilize resources to correct problems Document steps taken to correct problems Maximize the efficient use of… more
- HO PENN (Middletown, CT)
- …Must be computer proficient to be able to run diagnostic software and prepare service communications Must have strong communication skills and have a high level ... superior value. Troubleshoot problems Efficiently utilize resources to correct problems Document steps taken to correct problems Maximize the efficient use of… more
