Prepares other Scientific and Regulatory documents for submission to Regulatory Authorities including pre-IND Meeting Requests and Packages, Orphan Drug Designation requests, Priority Review requests, Fast Track requests, etc. Experience in preparing regulatory documents, publishing regulatory submi...
Ensures that protocol and regulatory documents are maintained and are kept up to date. Maintains study compliance with established local, state, federal, and DoD regulations for human subjects' research with institutional regulatory direction from USUHS, WRNMMC, and HJF. Maintains complete and accur...
Regulatory Health Communication Specialist, Mid. As a regulatory health communication specialist on our team, you’ll impact the development of creative solutions to complex public health challenges and priorities. ...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
The Regulatory Compliance Specialist is a critical member of the Regulatory and Laboratory Compliance team of Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences, Bethesda, MD. The Regulatory Compliance Specialist ...
As a Deputy Project Manager at Boeing Intelligence & Analytics, you will be responsible for supporting the Program Manager in managing a cutting-edge technology that will make a significant impact in the field of data management within the Object Management Service (OMS). The program architecture is...
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy. Accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory stra...
The incumbent will serve as an inter-agency consultant on compliance related matters. This person will review to ensure compliance of Davis Bacon certified payrolls and customer Reasonable Accommodation requests. Will manage and monitor compliance reporting, investigate, follow-up and follow through...
Senior Associate Regulatory Analyst. Econometrica is looking to hire a Senior Associate with Regulatory and Compliance Subject Matter Expertise within our fast-growing Data and Analytics Group. Other responsibilities will include managing and contributing to research projects, guiding junior staff, ...
We are seeking a Section 508 Compliance Analyst to provide support in managing, consulting and ensuring information and communication technology activities integrate appropriately with Section 508 compliance across the IT and acquisition lifecycles for the OCIO Customer Engagement Office in support ...
The Compliance Analyst role within the Housing Opportunities Commission of Montgomery County entails a comprehensive set of responsibilities critical to maintaining and enhancing the quality and compliance of our affordable housing operations. The Compliance Analyst is responsible for identifying an...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
Quality Assurance (QA) Specialist. We need an experienced Quality Assurance (QA) Specialist at the Naval Dosimetry Center (NDC). In this role, you assist command with your expert knowledge of quality management standards, accrediting agencies and regulatory requirements about laboratory operations, ...
Ripple Effect is looking for a part-time, 508 Compliance Document Specialist with 2 years of professional, relevant experience to support our clients' missions. Provide Section 508 Compliance document accessibility reviews and document remediation in accordance with 508 standards and requirement...
Ensure team completes all projects on time and within budget. Analyzes project from a technical perspective. Makes critical contributions to the design, production and fulfillment of project. Develop project timelines and assure adherence to schedule. ...
Regulatory Affairs Manager in the Gaithersburg, MD area. As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives. The RAM contributes to regulatory submission strategy, ide...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, re...
The Senior Manager, Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global team of public policy and regulatory affairs experts. Play an active role in supporting the execution of key projects within the International Government & Regulatory A...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
Will work closely with the Director of Compliance in preparing and implementing policies and procedures. Monitor compliance with policies and procedures. Train communities on compliance procedures. ...
As the Program Management Trade Licensing and Compliance Lead, you will help guide the mission areas by managing and assessing classification and jurisdiction and specially designed aspects of program hardware, software, technical data, and services enumerated under the ITAR, EAR, and Customs Regula...
Quality Assurance Specialist 2. Quality Assurance Specialist 2. Associate degree or a minimum of 2 years’ experience (directly related to Quality Assurance) in a medical environment and any combination of academic education, professional training, or work experience, which demonstrates the ability t...
The primary responsibility of the Compliance Specialist is to review clinical medical records and claims for accuracy of services related to home health care. The Compliance Specialist maintains a comprehensive understanding of ethical principles and independence in their work, professional conduct,...
Our work depends on a Cloud Program Manager (PM) joining our team to support one of our Federal customers in the DC Metropolitan area. Acting as prime technical / managerial POC for all Customer interface and communication on Program and responsible for overall Customer satisfaction. May serve as Pr...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regula...