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...
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...
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...
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...
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 Program Manager of Quality Assurance is responsible for overseeing and ensuring the delivery of high-quality services and supports to individuals in all DDA funded programs. Identify and coordinate behavioral services in conjunction with Case Manager and Person-Centered Plan, as needed. Provide ...
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...
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...
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...
The Program Manager position is a highly visible strategic position to ensure exceptional program execution in delivery of network services to NIH. Leidos Health Mission Solutions is seeking a Program Manager,. Provide overall direction of program activities, manage and maintain contractor interface...
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...
Key Concepts is looking for a Program Manager to manage a program with multiple Task Areas/Task Orders to include IT governance/CIO Support, Desktop, Service Desk, implementation of standards (ISO/CMMI), Network/Telecom infrastructure support, Asset Management, Training, Infrastructure Engineering, ...
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...
Civil Engineer-Project Manager. The ideal candidate would have experience with Managing Projects, Client Communication, Staff, and Mentoring Junior Engineers, as well as be able to plan, design, and coordinate projects from beginning through completion. Regular communication with assigned company Pr...
Overall 10+ years’ experience in program and project management. Should have managed at least 1 multimillion-dollar program through the whole lifecycle. ...
The Senior STIG Compliance Specialist plays a key role in enhancing the organization’s security posture and ensuring ongoing compliance with federal regulations. Lead and mentor junior compliance specialists and IT staff on STIG compliance best practices and procedures. Minimum of 8+ years of experi...
Budget & Fiscal Compliance Specialist, North America. HIAS seeks a Budget & Fiscal Compliance Specialist, North America to support our North America Programs in the creation and management of budgets, as well as the management of grants and cooperative agreements from initiation to closure i...
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...
The compliance analyst tracks federal and state benefits-related legislation and is responsible for interpreting regulations, pending legislation and enacted laws. The analyst responds to client questions regarding compliance. The analyst must synthesize the information into layman's terms for inter...
Syms Strategic Group, LLC (SSG) Program Manager Silver Spring, Maryland Apply Now. Syms Strategic Group (SSG) is seeking a talented Program Manager. If the customer is dissatisfied, the Program Manager informs corporate leadership and assists in the development of action plans to resolve current iss...