- Merck & Co. (Rahway, NJ)
- Job Description Responsibilities Design and implement file transfer system solutions based on business requirements. Configure and deploy file transfer protocols ... SFTP, and FTPS. Troubleshoot and resolve issues related to file transfers, ensuring minimal downtime. Monitor file ...to file transfers, ensuring minimal downtime. Monitor file transfer activities and proactively address any performance or… more
- Merck & Co. (North Wales, PA)
- …physical, or performance specifications.Lead and manage development of Global Design file (GDF) (Design History File -DHF) deliverables for medical devicesSkills: ... Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485).Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.Risk Management experience (ISO 1497124971, ICH Q9).Effective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), External Data Structure Specifications (eDTS) to ... readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements.Supports… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or administrator capacity Experience with metadata schema development, high-volume file transmissions, establishing naming conventions, cataloging and taxonomy for ... assets Experienced in one or more digital asset management technologies Excellent communication, presentation, and interpersonal skills, with the ability to explain complex concepts in a clear and concise manner A keen eye for detail, aesthetics, and user… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds and support ... building up oncology programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset and TLF… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug ... project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD).- Drug Development Strategy: Provides input to the entire development plan to ensure the overall… more
- Chatham (San Marcos, CA)
- …Receive and log incoming packages and deliveries accurately. Administrative Support: File and organize documents efficiently. Answer and direct phone calls as ... necessary. Assist management with various administrative tasks and projects. Creation and printing of company Certificates of Authenticity. Inventory Management: Monitor and manage office supplies inventory. Place orders for office supplies as needed to ensure… more
- Merck & Co. (Rahway, NJ)
- …engagement in the program-specific design controls process and design history file development.Author and review relevant portions of the regulatory submissions ... (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards.Lead/support/oversee clinical supplies production with respect to device component manufacture and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …readiness and quality initiatives pertaining to assigned stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Sr. CSM ... may act as the Study Team Leader for the assigned clinical study and responsible for leading the cross-functional study team, project managing and coordinating with internal stakeholders to ensure cross functional integration and delivery of study team plan… more
- BioAgilytix (Durham, NC)
- …Outlook, etc.), and automated liquid dispensing software. Must understand software and file permission settings as it pertains to data integrity and computer system ... validation.Detail oriented and highly organizedExcellent oral and written communication skillsVersatility, flexibility, and willingness to work within constantly changing prioritiesAbility to work collaboratively across departments and functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …readiness and quality initiatives pertaining to assigned stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate ... Director, Clinical Operations may act as the Study Team Leader for the assigned clinical study and responsible for leading the cross-functional study team, project managing and coordinating with internal stakeholders to ensure cross functional integration and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …contract work including GSA, Federal, HHS and DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee ... the daily operations of the LBRI Office of Research Contracts. Will work closely with the Director of Research Administration and other staff to identify staffing needs and available expertise, provide leadership and mentoring to all department staff, and work… more
- Tris Pharma (Monmouth Junction, NJ)
- …functional requirementsResponsible for organizing and maintaining the Engineering File Library.Creates and revises SOPs, as neededMaintains Laboratory, Manufacturing ... and Packaging equipment validation schedules, testing and developmental roll-outsPrepares appropriate Change Controls and performs associated tasks in an accurate, timely, effective and compliant mannerRequirementsKNOWLEDGE/SKILLS/ABILITIES REQUIRED Bachelors… more
- Everglades Equipment Group (Wellington, FL)
- …(1099's or tax exempt forms) Scan all invoices into system and destroy or file the paper copy as appropriate Assists other co-workers with related tasks as necessary ... within the Accounting Team. Experience with using Microsoft office Word, Excel and business system applications preferred Knowledge of agriculture equipment industry preferred, CDK Understands accounting fundamentals Ability to use standard desktop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the Manager for Patent Administration and works with patent/intellectual property attorneys, File Clerk(s), and other positions in IPD as well as with agents, ... patent authorities, and with relevant stakeholders throughout Novo Nordisk, including occasionally working with inventors in Novo Nordisk affiliates and frequent interaction with the administrative and professional staff in Novo Nordisk Corporate Patents… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Visio, MS Project) Physical Requirements: Shipping out large packages/boxes. Moving/arranging file folders in large quantities. 5% of Time. Travel Ability to ... travel up to 5% 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, national origin,… more
- PACIV (Miramar, PR)
- …Medical Device, F&B, and Water/Wastewater clients, is looking for a part-time File Clerk employee for our Puerto Rico office (San Juan). Position Overview: ... The File Clerk plays a vital role in maintaining the...filing, and retrieving documents, records, and other materials. The File Clerk will work closely with the Accounting Leader… more
- Highmark Health (Harrisburg, PA)
- …This job is responsible for corporate provider enrollment and provider file maintenance across all markets. This includes, enrollment, contracting and demographic ... and processing additions, updates, and deletions of provider information in the Provider File database. Ensures executions of data entry and updates are completed in… more
- Robert Half Office Team (New Orleans, LA)
- Description Robert Half has an opportunity for a File Clerk with our client in the Non-Profit industry. This role is based in New Orleans, Louisiana and is a ... short-term contract position. As a File Clerk, you will be involved in document management,...policy. You will also be working closely with our file room personnel, helping to maintain order and efficiency… more
- WellLife Network (Coram, NY)
- File Clerk - QAS060 - Mon-Fri 9AM-5PM Job Details Job Location Coram - Coram, NY Position Type Full-Time Education Level High School Salary Range $16.00 - $16.10 ... Category Admin - Clerical Job Description Position Summary: The File Clerk is responsible for providing records maintenance support...Department as directed by the Manager of HIM. The File Clerk is also responsible for ensuring that all… more
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