Bethesda, Maryland

Overview

Join the HJF Team!

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

This position will be in support of HJF's Regulatory Affairs Department.

Responsibilities

HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF's research programs with applicable local, state, federal and international regulations for human subjects' clinical trials with an emphasis on FDA Investigational New Drug studies. Familiarity with FDA regulated research for investigational drugs and devices, supportive animal model research, recombinant DNA regulations, and Health Insurance Portability and Accountability Act (HIPAA), is desirable.

The incumbent will embed in the clinical development team on behalf of HJF as study sponsor and lead the regulatory management of 1-3 IND studies. The incumbent will work in concert with other staff responsible for protocol development and life cycle management with the funders and investigators and other stake holders. The incumbent is therefore expected to bring experience relevant to FDA approval and monitoring of IND studies from conceptual inception through final reporting to FDA.

Responsibilities
  • Develop the communication and engagement plan for IND studies in respect to both the FDA and any other applicable regulatory authorities to include host nation entities outside the US.
  • Draft pre-IND and IND documents for FDA submission to CBER or CDER and if applicable other submissions such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and/or Premarket Approval Applications, (PMAs).
  • Draft communications, regulatory meeting agendas and minutes, and annual and safety reporting documents for the FDA and other regulatory agencies and ensure they are delivered to the relevant agencies in the format required in the required time frame. Participate in FDA meetings for IND/IDEs.
  • Maintains Trial Master Files for regulatory submission to the FDA for INDs and IDEs. Participates in protocol team meetings as the regulatory representative for HJF when the IND or IDE sponsor and in selected regulated studies as assigned.
  • Assists with maintaining a regulatory database and tracking database to include data entry, queries, and reports. Ensures required protocols are registered and up to date in clinicaltrials.gov. Review and provide comments on monitoring reports, SOPs, and other study documents.
  • May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role and training of other staff.

Required Knowledge, Skills and Abilities
  • Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA, HIPAA.
  • Knowledge and experience with Common Technical Documents (CTD), TMFs, INDs, IDEs. Must have experience submitting INDs and IDEs to the FDA and interacting with the FDA directly.
  • Excellent communication and writing skills; interpersonal and organizational skills; must be a self-starter and be able to work independently; must be able to multi-task.
  • Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, cloud-based eRegulatory platforms, and e-mail.

Qualifications

Work Environment
  • This position will take place primarily in an office setting.

Education and Experience
  • Bachelor's Degree is required.
  • Minimum 3-5 years of experience required.

Licenses and Certifications
  • RAC preferred.

All HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

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Bethesda, Maryland

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global organization dedicated to advancing military medical research. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.

The not-for-profit Foundation is authorized by Congress to support research at the Uniformed Services University of the Health Sciences (USU) and throughout military medicine. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. The Foundation’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and to accomplish their research goals effectively and efficiently.

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