Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
The Regulatory Affairs Specialist is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory aspec...
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...
What You’ll get to Do:* * Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team and line management * Reviews status of projects and budgets; manages schedules and prepares status reports * Assesses project issues...
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 ...
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 ...
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...
Serve as an environmental program manager and primary point of contact for client team. Manage large project/client environmental program and client relationships, delivering program tasks on time and within budget. Organize complex and concurrent program elements, provide routine status updates, an...
The Level 3 Quality Assurance Specialist shall possess the following capabilities:. We're searching for talented individuals who provide Quality Assurance support. Review and provide feedback to the Government on the documents and deliverables ensuring that quality assurance requirements adhere to t...
The Quality Assurance Specialist ensures that accounts meet all registration, compliance and billing requirements. The University of Maryland Baltimore Washington Medical Center (UMBWMC) provides the highest quality health care services to the communities we serve. Our medical center is home to lead...
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...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
Compliance Education Specialist. Office of Compliance Professional Fee Services Compliance Plan. Oversees compliance education activities in accordance with the Professional-Fee Services Compliance Plan. Serves as Lead for compliance training and prepares and/or reviews all billing compliance traini...
Minimum 3-5 years' experience as a Project/Civil Engineer or Project Manager or Estimator. Sr Project Manager Opportunity. ...
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. ...
Quality Assurance (QA) Specialist II. Helps champion implementation of the ManTech Quality Management System (QMS) on assigned projects to include adhering to defined processes, submitting supporting artifacts, and properly training staff members. Assist in gap analysis, audits, and appraisals as ne...
The Compliance Analyst will perform compliance based audits to determine if health care providers are adhering to applicable regulatory requirements. We have 45+ years of experience assisting our government clients with complex health care reimbursement and provider compliance issues, operate 20 off...
Project Time Management, Project Stakeholder Management, Project Planning,. Project Procurement Management, Project Tracking. Leads and manages projects consisting of multiple teams and/or requiring integration with other activities Coordination with Site Engineers and Contractors for New branch, Br...
Develops Compliance Hotline statistical data for reporting to the Audit and Compliance Committee of the Board of Directors, the Executive Compliance Committee, the Affiliate Compliance Officer Committees and other meetings as requested. Works collaboratively with the Compliance Director in compiling...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
The Pharmacy Program Manager position is a 100% remote role requiring a HIPAA-compliant workspace. A Pharmacy Program Manager is a Clinical Pharmacist providing pharmacist support for an interdisciplinary care management team and members under assigned plan sponsors through conducting comprehensive ...
School of Medicine - Epidemiology and Public Health....
Review and approve company, product, and producer advertising material for compliance with state and federal advertising laws and regulations. Participate in regulatory and corporate audits for advertising compliance. Contribute to the development of new and/or enhanced compliance programs and enter...
The Project Manager will be responsible for managing and leading all aspects of projects related to Product Lifecycle Management (PLM) applications and associated engineering systems implementation including Project Initiation, Planning, Execution, Monitoring and Control, and Closure. The Project Ma...
The Project Developer will manage the development portfolio in Maryland, Pennsylvania and Illinois, leading full project lifecycle responsibilities from site selection through permitting and interconnection to NTP. Manage project timelines, budgets, and resources to ensure successful project deliver...