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 Awaits You? Career growth and development Tuition Assistance Diverse and collaborative working environment Affordable and comprehensive benefits package Location: Johns Hopkins Hospital, Baltimore, MD-Core Laboratory Days-7am-3:30pm Position Summary: Reports to the Director, Laboratory ...
What Awaits You? Career growth and development Tuition Assistance Diverse and collaborative working environment Affordable and comprehensive benefits package Location: Johns Hopkins Hospital, Baltimore, MD-Core Laboratory Days-7am-3:30pm Position Summary: Reports to the Director, Laboratory ...
Job Opportunity: Specialist, Quality Assurance (QA) ,MD. The Specialist, QA will play a vital role in providing Quality Assurance support for GMP manufacturing of master/working cell banks, biological bulk drug substances, and finished drug products intended for human use. This position involves on-...
This position is responsible for planning, prioritizing, and organizing compliance tasks for clients including Policy and Plan Document Coordination, Non-Discrimination Testing, Form 5500 and SAR Preparation, Health Care Reform compliance, other health and welfare compliance needs. Maintain accurate...
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...
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...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
Has responsibility for leading/managing of technical projects and/or programs during Implementation that fall outside of core IT functionality / scope. Ensures the end state of the project meets business objective(s) and that all deliverables and due dates are met. Ability to manages complex project...
You'll be a member of the Content and Policy Analyst that define content standards and outline policy and inclusion criteria for our FCC and Trade Compliance business. You will support the management of our World Compliance data, specifically the maintenance and dissemination of our researcher-facin...
Responsibilities The primary duties of the Project Manager are to provide administrative and scientific oversight of NEXTGEN in concert with the Direct and the Core Project Administration and related management structures. The School of Agricultural and Natural Sciences (SANS), University of Marylan...
The University of Maryland Eastern Shore (UMES) STEM STARS program is accepting resumes for a full-time, 12-month, grant-funded position of Project Manager beginning in May. Responsibilities The Project Manager will assist the Executive Director in developing and implementing plans and goals for the...
The Technical Project Manager will support high-priority Digital Transformation efforts by providing management, coordination, technical expertise in the execution of approved projects, owning the technical lifecycle through to completion, according to planned milestones and within budget. The Techn...
Project management skills required to include the use of a formal process and system for planning and tracking ongoing progress of clinical projects. Under the direct supervision of the manager, the CPM will:. Demonstrate understanding of BD’s general business functions, products, and procedures and...
The Research Program Manager will be involved in the management of a research program at UMES on the effects of cover crops on soil carbon sequestration and their use as bioenergy feedstocks. The Department of Natural Sciences at the University of Maryland Eastern Shore (UMES) invites applications f...
This role provides leadership and guidance for the company’s transportation safety and compliance processes (DOT/FCSMA & internal policies), while assisting various organizations with transportation operations to maintain compliance. The Analyst will partner with Fleet Safety Director in craftin...
Further, the CICI will manage instructional programs and initiatives focused on process, business management,and efficiency to achieve peak organizational performance, including the development, implementation, andongoing evaluation of training programs and initiatives within OSP. Demonstrated exper...
We are looking for a motivated and detail-oriented Entry-Level Project Manager to join our IT team. This is an exciting opportunity for a recent graduate or early career professional eager to start a career in project management. The ideal candidate will assist in managing projects from inception th...
This is a fantastic opportunity for a Electrical Project Manager to join our major, global pharmaceutical client on their latest new-build project based in Maryland, this is a large-scale greenfield capital project and investing more than $1bn. Electrical Project Manager - Site & Infrastructure - Ma...
The Senior Program Manager Ports and Borders will oversee coordination, management, and execution of all program activities to include Civil Works scoping, management and execution, delivery of products and/or services, demonstration of customer specification performance and quality, scope managemen...
Reporting to the Director of Finance, the Program Finance Manager (PFM) is responsible for all program accounting, billings, program finance reporting, EAC’s, forecasting and partnering with the Program Manager’s and Sales teams from pricing to financial reporting of the programs. Prepare budgets fi...
The Project Manager is responsible for overall project planning and scheduling, resource allocation, project accounting, price book estimating, and control while providing technical direction and ensuring compliance with quality standards. The construction project manager's responsibilities span a b...
Looking to hire an experienced Project Manager for a MD-based general contractor. Review with superintendent project costs to ensure the project is kept within budget. Potential supervisory responsibilities of an Assistant Project Manager. This is an excellent opportunity to join apany with a proven...
As Director of Regulatory Affairs, you'll play a key role in leading US regulatory efforts, working across departments to develop submission strategies, manage timelines, and engage with health authorities. Director of Regulatory Affairs - Join a Leading Biotech Innovator!. Are you a skilled Regulat...
We are seeking a highly motivated Virtual Reality Project Manager to lead our team in the successful. Knowledge of programming and 3D modeling. ...