- Cepheid (Miami, FL)
- …for functioning as Lead Internal Auditor to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing ... the opportunity to:Function as Lead Auditor to schedule, plan, perform, and document internal audits to provide continuous and rigorous assessment of the Cepheid… more
- Lilly (Durham, NC)
- … / external environments and advocate / influence quality related policies and regulatory requirements related to Document Management . + Responsible for ... people around the world. **Responsibilities** The Senior Director, Global Process Owner for Document Management , as a leader within the Global Quality Systems… more
- Takeda Pharmaceuticals (Boston, MA)
- …managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking ... + Significant experience in global drug development regulations, regulatory submissions, lifecycle management , compliance, business systems technology and… more
- Bank of America (Charlotte, NC)
- Global Regulatory Reporting Observation Management Sr. Specialist Charlotte, North Carolina **Job Description:** At Bank of America, we are guided by a common ... management approach **Required Qualifications:** + 3-5 years experience regulatory reporting in the financial industry + Prior consulting and/or issues… more
- Catalent Pharma Solutions (Harmans, MD)
- …+ Responsible for implementation, management , and enhancements of an electronic Document Management System (eDMS). **The candidate:** + Bachelor in a Life ... lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval,… more
- Fresenius Medical Center (Waltham, MA)
- …+ In-depth knowledge of electronic publishing tools and Regulatory Information Management (RIM) systems. + Proficiency with electronic document management ... systems designed to ensure compliance with electronic submission requirements and document management systems. In addition to publishing responsibilities, this… more
- North Wind Group (Richland, WA)
- …+ Hanford Systems used to provide support are comprised of the following: + Document Management and Control System (DMCS) + Smart Plant Foundation (SPF) + ... policies and procedures to ensure compliance with legal and regulatory requirements. + Work with key stakeholders to establish...Hanford Document Numbering System (HDNS) + Integrated Document Management System (IDMS) + Records … more
- Lilly (Pleasant Prairie, WI)
- …BA/BS. + 3 to 5 years in a GMP environment. + Thorough knowledge of Document Management practices and principles in a Corporate and GMP environment. + Establish ... to those who need them, improve the understanding and management of disease, and give back to our communities...and effective products and to meet customer expectations and regulatory requirements. The Senior Specialist - Document … more
- Savannah River Mission Completion (Aiken, SC)
- … regulatory stakeholders. **Responsibilities** + Coordinate efforts of multiple document developers to prepare tank closure regulatory documentation(similar ... **Overview** Savannah River Mission Completion is seeking ** Regulatory Documentation Coordinator** to be based in our Aiken, SC location on the Savannah River Site.… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory… more
- Charles River Laboratories (Malvern, PA)
- …+ Maintain historical files for SOPs and forms. + Assure that site document management strategies and regulatory requirements for electronic documents ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...flow and final release of controlled documents through the document management system. + Serve as the… more
- Wells Fargo (New York, NY)
- **About this role:** Wells Fargo is seeking a Lead Capital Markets Document Negotiator for the negotiation of various trading agreements as part of the growth of ... manage priorities as necessary). + Work on various projects, including regulatory implementation, amending and updating templates, processes and systems. + Interpret… more
- Amgen (Washington, DC)
- … Information Management System (eg VeevaVault) and support the department in regulatory document management activities. + Maintain regulatory ... global registration activities + Assessing the impact of relevant drug and IVD/CDX regulations on drug and...credentials. **Basic Qualifications:** **Must have in depth knowledge of regulatory document management systems including… more
- Takeda Pharmaceuticals (Boston, MA)
- …and management , metadata standards and data discoverability; Maintain the Regulatory Data Catalog: Document Data classification and quality rules; Identify ... including regulatory submissions, labeling, and product tracking; Oversee Regulatory Document data classification rules, compliance/retention rules, and… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies ... strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment… more
- Lilly (San Francisco, CA)
- …could impact the global product strategy or brand. + Enable discussion of the regulatory strategy document and regulatory issues/challenges at the ... to those who need them, improve the understanding and management of disease, and give back to our communities...(ie, PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR… more
- J&J Family of Companies (Raritan, NJ)
- …protocols and ensure alignment with regulatory requirements + Provide regulatory support throughout registration process and life-cycle management + Advise ... in place on time + Draft and review some document content (depending on level of regulatory ...drug development process + Basic understanding of the regulatory submission and approval process + Knowledge of US… more
- Teva Pharmaceuticals (West Chester, PA)
- …5% international travel required. **Your experience and qualifications** Bachelor's degree in Drug Regulatory Affairs, Pharmacy, Biology, Chemistry, or a related ... Guidance Documents and Code of Federal Regulations + Electronic Document Management Software; Change Control and GMP...or Batch Records + Regulatory Reporting Requirements, Regulatory Assessments and Impact on Implementation + Drug… more
- Savannah River Mission Completion (Aiken, SC)
- **Overview** Savannah River Mission Completion (SRMC) is seeking a ** Regulatory Document Developer** to be based in our Aiken, SC location on the Savannah River ... support for tank closure and salt waste disposal activities and projects. The ** Regulatory Document Developer** will interface with regulatory stakeholders,… more
- Sanofi Group (Morristown, NJ)
- …planning activities, including generating submission content plans, submission tracking, and document management + The RS participates in the development ... **Job Title:** Regulatory Strategist - mRNA Vaccines **Location** : Swiftwater,...is a plus + Ability to work in electronic document management systems, eg, Veeva Vault is… more
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