The Department of Cancer Immunology is seeking a Regulatory Specialist II  who will serve as a central resource for faculty conducting clinical research at Johns Hopkins University and across multiple clinical trial sites. Working closely with the Sponsor-Investigator and IND Specialist, this position will assist in the submission of investigator initiated trials to the appropriate regulatory agencies for review, such as the Food and Drug Administration (FDA). In addition, this position will assist in the ongoing maintenance of Sponsor-Investigator held INDs. This includes, but is not limited to protocol amendments, Investigator Brochure amendments, annual reports, IND safety reports, Chemistry, Manufacturing, and Controls (CMC) updates, and oversight of investigational drug supply. 

Specific Duties & Responsibilities:

• Provide assistance in the submission of Investigational New Drug Applications (IND)
• Provide regulatory guidance to IND sponsors, clinical investigators, and clinical staff for investigator initiated clinical trials

• Provide assistance with IND management and submissions
• Coordinate and review documentation for amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs
• Compile and maintain IND Sponsor regulatory files (digital and hard-copy) throughout the lifecycle of sponsorship by ensuring that incoming and historical documents are organized and filed appropriately
• Review clinical trial databases to assess clinical data quality and accuracy
• Monitor investigational drug supply

Minimum Qualifications (Mandatory):

• Bachelor's Degree in Health Sciences, Biological Sciences, or related field
• Advanced Degree in Regulatory, Health Sciences, Biological Sciences, or related field is preferred
• Requires a minimum of three years clinical trial regulatory experience at an academic, government, or pharmaceutical industry environment
• Additional education may substitute for experience

Special Knowledge, Skills, or Abilities:

• Good verbal and written skills are required, as is a basic knowledge of computer science
• Ability to work independently 

JHU Equivalency Formula:  30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience.  Additional related experience may substitute for the required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job. 

Classified Title: Regulatory Specialist II
Role/Level/Range: ACRP/03/MB 
Starting Salary Range: $39,310 - $54,060 annually (commensurate with experience)
Employee group: Full Time 
Schedule: M-F 8am-4pm 
Exempt Status: Exempt  
Location: ​​​​​​​School of Medicine Campus 
Department name: ​​​​​​​Cancer Immunology/GI Clinical Research 
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons or because the individual is pregnant or attempting to become pregnant. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply depending on which campus you will work.  Your recruiter will advise accordingly.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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