JPEO-CBD Regulatory Affairs Manager
Noblis - Fort Detrick, MD

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Noblis is a nonprofit science, technology and strategy organization that helps clients solve complex systems, process and infrastructure problems in ways that benefit the public. We bring the best of scientific thought and engineering know-how to find solutions that are practical, efficient and effective. You will find Noblis at work in many fields, including information technology and telecommunications; management consulting; national and homeland security; transportation; healthcare; criminal justice; energy and the environment; oceans, atmosphere and space; and public safety.

Noblis is consistently recognized as a "Great Place to Work" and "One of the Best Mid-Sized Companies to Work For" by the Society for Human Resource Management (SHRM), the Great Places to Work Institute, and AARP. Noblis was also named to the "World's Most Ethical Companies" list by the Ethisphere Institute at the Forbes, Ethisphere Joint Conference.

Noblis maintains a drug-free workplace Equal Opportunity Employer

Responsibilities:

Positions available at Aberdeen Proving Ground, MD and Ft. Detrick, MD.

The candidate shall support the Joint Program Executive Office for Chemical And Biological Defense (JPEO-CBD) and the Joint Project Management Offices (JPMOs) which report directly to the JPEO-CBD.

Noblis is seeking a qualified Regulatory Affairs Manager for support to the Joint Program Executive Office (JPEO) contract specifically the Medical Domain to assist in the organization, planning, assessment, and management of regulatory affairs (i.e., FDA) and quality assurance activities to support the research, development, and acquisition of JPEO-CBD medical systems.

This support includes, but is not limited to, the following: participating on IPTs; Preparing, reviewing, and coordinating regulatory documentation; researching, troubleshooting, and communicating solutions to resolve technical issues related to regulatory documentation; and ensuring that regulatory documentation is compliant and consistent within the DoD Acquisition Framework; supporting development of POM recommendations and Congressional and Office of the Secretary of Defense briefings; maintaining relationships with the FDA and other Federal agency personnel, as necessary; providing coordination and staff support for regulatory, pharmaceutical, and portfolio integration chiefs.

Qualifications:

Successful completion of a full course of study in an accredited college or university leading to a Master’s Degree, preferably with a major in Engineering, Science, Systems Management, Business Management, or a related discipline, is required. DAU Level III certification in PM, SPRDE, or the civilian equivalent, is preferred. A combination of a Bachelor’s Degree in Program Management, Science, Engineering, Systems Management, Business Management, or a related discipline, DAU Level III certification, or civilian equivalent, in PM or SPRDE, and ten (10) years of experience may be substituted for a Master’s Degree.

Four (4) to ten (10) years of general experience including two (2) to five (5) years of experience in a program office or similar organization. Knowledge of current DoD acquisition regulations, policies, and guidance; commercial science and technology in early development; pharmaceutical technology transfer best practices; and healthcare informatics is required.

Active Secret security clearance is desired.

Noblis - 23 months ago - save job
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