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 ...
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...
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...
CACI is seeking an Artificial Intelligence (AI) Program Manager to lead an exciting new program at our client’s site in Bethesda MD. Ensure the Government Program Manager and senior level management within the client organization are aware of overall program status including risks, strategic options...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine. Understand the constraints and drivers of other functions and the potential impact on regulatory affairs World-wide, including how regulatory affairs may facilitate ...
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 Assistant Project Manager is responsible for assisting the Project Manager with planning, directing, and coordinating, daily construction management activities. Reviewing project budget and timeframe with the Project Manager, and ensuring a good understanding. Assist the Project Manager and Supe...
Track all program cost, schedules and performance against established program milestones; reporting the status to management stakeholders on a regular basis. Ensures program methodologies for the LOB and/or CO and the program management directives are followed. Understand and develop methodologies t...
MORI Associates is seeking a Project Manager to provide remote project management support for the Office of the Chief Information Officer (OCIO) in support of the NASA Enterprise Multimedia and Integrated Technical Services (eMITS) contract. As a Project Manager III you will be part of a dedicated t...
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 ...
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...
We are seeking a Project Manager in our DC office located in Arlington, VA office to manage select projects while developing and growing a group that is capable of executing large scale projects on a regional and national basis. The Project Manager is responsible for not only their projects but help...
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...
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...
AECOM** is currently looking for an experienced Program Manager to join our Germantown, MD team, leading some of the most complex programs globally. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digit...
The compliance analyst will work alongside a dedicated team of highly trained compliance professionals to ensure our projects meet their compliance objectives. The Compliance Analyst serves as the project compliance expert on a wide portfolio of Clarks government-funded construction projects. This i...
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...
GLOTECH is seeking a Project Manager to work in a collaborative team environment in support of projected new work with our client. Six (6) or more years of hands-on intermediate to expert level experience in planning and executing projects that effectively streamlined and improved enterprise governa...
Manages full project life cycle from project initiation to project closure. Has the ability to mentor Project Coordinators and other Project Managers. We are looking for a Senior Project Manager to join our Digital Services group within the Advisory Department. As a Senior Project Manager you will b...
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...
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. ...
The Analyst will play a pivotal role ensuring compliance with federal funding while supporting various components of the Compliance team. Climate United Fund, a 501(c)(3) nonprofit (“Climate United”), is seeking a full-time Compliance Analyst for an entry level position to support adherence to regul...
Through more than 50 programs across the district and five surrounding counties, Catholic Charities is opening doors to help and hope. Employee referral bonus program. The Case Manager provides direct management services including identifying and coordinating community resources. Complete reports an...