Regulatory Affairs Officer

Employer
Johns Hopkins University
Location
Maryland, United States
Salary
Salary Not Specified
Closing date
Sep 25, 2021

View more

Position Type
Administrative, Academic Affairs, Research Administration, Business & Administrative Affairs, Other Business & Administrative Affairs
Employment Type
Full Time

Job Details

The Pathology Department seeks aRegulatory Affairs Officer (Human Research Compliance Associate) who will serve as the Director of Regulatory Affairs for the HIV Prevention Trials Network (HPTN) Laboratory Center (LC). This position will serve as the primary point of contact and liaison with laboratories and Cores within the HPTN, and provide leadership and oversight to ensure regulatory compliance with laboratory operations.

Specific Duties & Responsibilities:

  • Ensure that activities within the HPTN LC meet legislative and appropriate oversight requirements.
  • Responsible for maintaining a current knowledge of regulatory guidance, including, but not limited to, the United Stated Food and Drug Administration, European Medicines Agencies, International Council for Harmonization, International Organization for Standardization, the South African Health Products Regulatory Authority, and the United Kingdom Medicines and Healthcare Products Regulatory Agency, amongst others.
  • Able to review and audit for institutional training, completeness of laboratory-specific training, and competency compliance for personnel within the HPTN LC.
  • Demonstrate good writing skills in order to develop Standard Operating Procedures (SOP), participate in Request For Proposals (RFP) responses and produce internal and external audit reports ready for final edit.
  • This position seeks opportunities to improve HPTN LC operations through the application of quality improvement methods to HPTN study initiatives.
  • Tracks and reports progress on quality improvement results or outcomes, identifies gaps in current performance, and strategizes to achieve improvement with sustainability.
  • Responsible for the design, implementation, and monitoring of programs associated with the Regulatory and Quality initiatives of the HPTN LC.
  • Role requires interaction with JHU Office of Research Administration (ORA), Purchasing and the Comptroller’s office as well as established networks of senior level laboratory professionals, other network personnel (including the HPTN statistical and data management center and leadership and operations center), donors/sponsors with awareness for working in multiple socio-economic settings and with multi-cultural groups in developing countries.
  • This role will also work with the ORA and HPTN finance leadership in the maintenance of contracts and material/specimen transfer agreements.

Minimum Qualifications (Mandatory):

  • Education in biology, chemistry, laboratory science, or related medical field.
  • Candidate with Masters or PhD. degree with significant regulatory/industry experience.
  • Five years progressive responsibility in a regulated environment, which may include a clinical setting, industry or government.
  • Regulatory oversight and familiarity with US FDA, EMA, ISO and ICH guidance.
  • Strong organizational skills, writing and editing abilities and high-level computer skills.

Preferred Qualifications:

  • Exposure to working internationally or supporting international projects.

Special Knowledge, Skills & Abilities:

  • An understanding and appreciation of relevant regulatory, scientific, and manufacturing areas is also necessary.
  • Experience working with Federal regulations and sponsored projects for educational institutions.
  • Familiarity with the regulatory agencies involved in human subjects’ research and oversight as well as the ethical considerations related to human subjects is highly desirable. Must have the ability to apply regulatory requirements to proposed research protocols, exhibit skills in conducting research using electronic methods, and possess exemplary writing and verbal skills. Experience in group processes and dynamics is required.
  • Excellent verbal and written communication skills required. Excellent organizational skills, strong attention to detail and the ability to manage multiple tasks simultaneously required. Excellent interpersonal skills and cultural sensitivity required. Strong computer and IT skills.
  • Experience in project management, and international research or projects preferred. Formal training in project management and strong knowledge of project management software programs.
  • Ability to work independently in a small team environment, but also to collaborate with other office members and outside contacts in the pursuit of team goals.

Physical Requirements:

  • While performing the duties of this job, the employee may remain in a stationary position (sitting) up to 75% of the time when at the office.
  • The employee is required to operate computer keyboard for a significant portion of the work day.
  • Prolonged vision requirements including viewing computer screen, paper reports/documents, charts and results.

Work Environment:

  • While this position is primarily in an office setting, there are times where employee may be exposed to a medical or laboratory environment.
  • Exposure to toxins and infectious agents exist, but potential for personal injury or harm is minimized if established safety and health precautions are followed.
  • Must refer to and are expected to comply with procedure manuals, follow proper laboratory protocols and safety policy/procedures, and be familiar with material data safety sheets in assigned work areas.

Staff may be required to complete annual competency review, and must insure compliance with Johns Hopkins Policy, Laboratory Policy & Procedures, Health, Safety & Environment regulations, and all applicable privacy & confidential laws/practices.

* Hybrid telecommuting is an option (2 day at home)**

Classified Title: Human Research Compliance Associate
Working Title: Regulatory Affairs Officer
Role/Level/Range: ATP/04/PE
Starting Salary Range: $69,830 - $95,950 annually (commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:00am - 4:30pm
Exempt Status: Exempt
Location: ​​​​​​​School of Medicine Campus
Department name: ​​​​​​​SOM Pat HIV Clinical and 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 atjhurecruitment@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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

School of Medicine - East Baltimore Campus


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.

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

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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