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...
The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). 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 w...
Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulat...
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...
Responsible for providing services to the Compliance Group to ensure the corporation's compliance with relevant laws, executive orders, directions, and regulations governing mission activities. Use compliance-related tools to audit, monitor, or gather oversight and compliance data. Coordinate compli...
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...
Administrative Unit Program Manager. The Program Manager will be responsible for ensuring the Task Order team completes their work on time and within budget, as well as guiding the teams as needed. With experts in biomedical science, software engineering, and program management, we focus on developi...
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...
Position Summary:A CCS Program Manager has operational responsibility of the CCS program to include regulatory compliance and program specific outcomes related to the strategic plan. Under the direct supervision of the CCS Vice Presidents, Program Managers maintain program efficiencies as well as ov...
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...
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...
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...
Project Manager - MSP Transition (East Coast). We are seeking an experienced Project Manager to support and lead the transition of Managed Service Providers (MSPs) within our client's organization. Minimum of 3+ years of experience in project management, specifically related to MSP transitions. ...
Overview: The Senior Risk and Compliance Analyst is internal to Inovalon and part of the Security, Risk and Compliance department that partners with Technology, business groups, and project teams to perform risk and compliance activities and audits for applications, infrastructure, and vendor/third ...
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...
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 ...
Develop program roadmap to execute requirements for 20+ projects. ...
The Program Manager of Commercial Operations is responsible for the leadership, management, and growth of a profitable Commercial Operations Department. This position is located in Largo, MD and reports directly to the General Manager. Promote and enforce compliance with Phoenix's Safety Programs, Q...
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...
AT&T has an opening for a Service Project Manager to perform all tasks project manager, which may include working with the higher level program manager, to provide effective and efficient management of the contractor's effort. Provide guidance and direct tasking for Level 0, 1, and 2 project manager...
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...
As Senior Project Manager, you will be part of a leadership team dedicated to providing world class service to our clients by leading the day-to-day management of the project. The Senior Project Manager will communicate with the project stakeholders, manage risk and monitor progress against the sch...
The Project Manager will, using the Agile framework, build, direct, plan, execute, evaluate and maintain all project/technical support activities; the PM will also monitor project intake and project closeout as client initiatives come up. Agile Project Manager for a project at a large NIH support or...