Regulatory Affairs Manager IV
Clinical Research Management - Frederick, MD

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Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at Ft. Detrick. If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.

We are currently seeking a Regulatory Affairs Manager IV for the Frederick, MD area.

RESPONSIBILITIES:

  • The offeror shall 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
  • Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
  • Performs light duties and other related duties as required and assigned.


  • MINIMUM QUALIFICATIONS:

  • Education: 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, 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, Engineering, Systems Management, Business Management, or a related discipline, DAU Level III certification in PM or SPRDE, and ten (10) years of experience may be substituted for a Master’s Degree.
  • General Experience: Ten (10) years of general experience and five (5) years of experience in a program office or similar organization
  • Must be able to work independently following a brief period of specific technical training.


  • Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

    ClinicalRM is an Affirmative Action-Equal Opportunity Employer

    www.clinicalrm.com

    “NorthCoast 99” Best Places to Work recipient

    About this company
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    ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.