- Teva Pharmaceuticals (Parsippany, NJ)
- …registrations. The Director offers clear guidance, leadership, accountability for the preparation of quality, fit-for-use clinical regulatory documents for ... guidelines, ICH guidance, and Teva standards + Leads/contributes to the preparation /revision of document templates + Participates in the recruiting/hiring… more
- Astellas Pharma (Westborough, MA)
- …storage database run reports for retention and metrics. + May also support the preparation and hosting of internal audits and regulatory (eg, FDA, EMA, DHHS, ... **Senior Document Specialist** Do you want to be part...an EDMS. + Familiar with applicable US and international regulatory requirements (eg, 21 CFR Parts 11, 210, 211,… more
- Sanofi Group (Cambridge, MA)
- …and/or innovative biologics products + Demonstrated experience with driving the preparation of regulatory documents (eg (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health ... ** Regulatory Strategist** + Location: Cambridge, MA + Remote...+ Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial… more
- Fresenius Medical Center (Waltham, MA)
- …maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information ... AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required… more
- Siemens (Roebuck, SC)
- …The Siemens Industry, Inc. distribution center in Roebuck, SC is seeking an **EHS Document Control Assistant,** to be an integral member of a diverse and dynamic ... team. As an **EHS Document Control Assistant** , you will be responsible for...documents are accurately filed, easily accessible, and comply with regulatory and company standards. This position offers the chance… more
- New York State Civil Service (Albany, NY)
- …of ongoing litigation or regulatory matters. * Assist in the preparation of privilege logs, document summaries, and other relevant documentation.* ... HELP No Agency Attorney General, Office of the Title Staff E-Discovery Document Review Attorney(6340) Occupational Category Legal Salary Grade NS Bargaining Unit M/C… more
- LA Care Health Plan (Los Angeles, CA)
- …with business units in audit universe preparation and validation. Assists in document preparation for regulatory and internal audits. Regulatory ... the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance...the deficiencies. This position will be responsible for the regulatory obligations for each line of business and their… more
- University of Miami (Medley, FL)
- … preparation , scanning, and indexing activities, customer communication, and regulatory requirements related to privacy and security, preferred + Previous ... Health Information Management has an exciting opportunity for a Full Time Supervisor, Document Management to work at UHealth. The Supervisor, of Document … more
- Kelly Services (Freeport, TX)
- …management or administrative roles, preferably within an EH&S context. + Experience with regulatory compliance and audit preparation is a plus. **Skills:** + ... The EH&S Document Administrator is responsible for managing and maintaining...Health & Safety (EH&S) documentation to ensure compliance with regulatory requirements and company policies, supporting our three sites… more
- TXNM Energy (Albuquerque, NM)
- …as assigned. + Facilitates process for self-certifications, on-site audits, and the preparation of self-reports and mitigation plans for regulatory violations. + ... Creates and maintains any and all document repositories necessary for PNMR and its affiliates to...annual self-certification, spot checks, on-site audits, investigations and the preparation of self-reports and mitigation plans for regulatory… more
- Salado Isolation Mining Contractors (Carlsbad, NM)
- …and has excellent communication skills (written and verbal). Responsibilities: + Perform document control duties, from preparation to issuance, in accordance ... CCP Document Services Technical Editor Department:WO-CC CCP Compliance Location:Carlsbad,...The successful candidate will be responsible for coordinating the preparation , review, approval, and issuance of controlled documents. Will… more
- J&J Family of Companies (Columbus, OH)
- …Writing interdependencies between all major documents of electronic Common Technical Document (eCTD) is required. + Experience conducting Regulatory Medical ... Director, Regulatory Medical Writing (1 of 4) - 2406211847W...Development Teams (CDTs) at the early stages of submission preparation and the RegMW expert for the delivery of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …+ works closely with Regulatory Publishing to ensure electronic Common Technical Document (eCTD) compliance. + reviews and leads preparation of IMPD to ... support international CTA submissions. + oversees preparation of regulatory submissions to ensure compliance with all FDA regulations and guidelines. + Ensures… more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Regulatory Project Manager (Department of Neurology) Job Profile Title Manager Research Project ... of Medicine. The purpose of this position is to be responsible for regulatory activities in a large translational research center with federally funded (NIH, NIA,… more
- Taiho Oncology (Princeton, NJ)
- …Provide management level guidance to all functions in the preparation of regulatory documents in the eDMS (Electronic Document Management System). + Advise ... Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA * Princeton,...marketing commercial support. + Technical expertise in handling electronic document management system (eDMS). + Management experience with personnel,… more
- Robert Half Legal (Denver, CO)
- Description Robert Half is seeking a Document Review Attorney to join our client's team in Denver, Colorado. This role functions within the legal industry, ... specifically focusing on litigation and document review, and offers a long term contract employment...estate law in daily tasks * Assist with the preparation of legal documents such as briefings and handle… more
- Defense Logistics Agency (Battle Creek, MI)
- …information regarding this job. Responsibilities Serves as customer advocate for Document Services by providing customer service and marketing services to both ... customer's desktop publishing requests. Furnishes technical advice regarding the preparation , design, layout, specifications, production and distribution methods for… more
- SpaceX (Hawthorne, CA)
- …environmental management, engineering or planning related field + Demonstrated experience in document preparation and attention to detail in either academic or ... Sr. Environmental Regulatory Engineer (NEPA) at SpaceX Hawthorne, CA SpaceX...documentation + Collect and analyze data to support the preparation of environmental documents + Prepare and develop coordination… more
- Sanofi Group (Waltham, MA)
- **Job title: Regulatory Strategist** + Location: Bridgewater, NJ or Swiftwater, PA or Waltham, MA (ability to work onsite 2-3 days each week per hybrid working ... adults. Our team is responsible to develop and execute regulatory strategy for this new asset to protect toddlers...launch. + Lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial… more
- Medtronic (Plymouth, MN)
- …of company, internal audits, and inspections + Directs or performs coordination and preparation of document packages for regulatory submissions from all ... + Maintain Regulatory Affairs documentation to support compliance with applicable regulatory requirements + Coordinate and prepare document packages for … more