Regulatory Affairs Manager

October 4

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The Geneva Foundation

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Federal Grant and Contract Management • Clinical Trials • Education • Federal Contracts • Military Medicine

201 - 500

Description

• The Regulatory Affairs Manager will report directly to the Senior Regulatory Affairs and Data Manager • Oversee assigned regulatory team staff, oversee and submit regulatory lifecycle actions for all projects within the program • Serve as principal administration regulatory liaison for projects • Develop and maintain recordkeeping systems and procedures • Oversee and prepare essential research documents • Oversee and perform submissions to the IRB • Provide audit support • Ensure program-wide research regulatory lifecycle compliance • Serve as programmatic subject matter expert (SME) for regulatory affairs actions • Oversee, prepare, and track regulatory lifecycle actions submitted to the Institutional Review Board (IRB) • Assist with the development of essential research documents such as protocols • Negotiate, coordinate, and track the use of IRB reliance agreements

Requirements

• Bachelor’s degree or equivalent work experience required • Regulatory and IRB submission experience required • 3-5 years military/DoD research experience preferred • 3-5 years’ clinical research experience preferred • 3-5 years’ non-profit, research, or healthcare experience preferred • Ability to provide strong leadership, innovative thinking, creative planning, and effective motivation skills to staff required • Ability to exercise independent judgement in a fast-paced, high-pressured environment, accommodate strict deadlines, and manage multiple projects required • Must demonstrate high quality oral and written communication skills • Must be organized, have strong attention to detail, and possess a positive, friendly and professional demeanor • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner

Benefits

• medical, dental, and vision healthcare • Flexible Spending Account • Health Savings account, with employer contribution • Coverage for employees and family members including domestic partners • Short-and long-term disability • Employee Assistance Program • Life & ADD insurance • 403b retirement plan with generous employer match • flexible leave options • 11 paid holidays per year • up to 4 weeks of paid time off in a rolling year • May qualify for PSLF as a 501(c)(3) nonprofit organization