Product and Regulatory Specialist

Product and Regulatory Specialist 

Parsons is seeking a Vaccine Product and Regulatory Specialist to support vaccine product development and clinical vaccine trials at the Walter Reed Army Institute of Research (WRAIR) in the Malaria Vaccine Branch located in Silver Spring, Maryland. WRAIR has a distinguished history of serving America's military. It was founded by the U.S. Army Surgeon General George Sternberg in 1893 as the Army Medical School and is widely recognized as the oldest school of public health and preventive medicine in the United States. The vision of the Military Malaria Research Program is to lead and support US and international malaria diagnostics, drug and vaccine development efforts by providing knowledge, expertise, training, and products for Force Health Protection and in support of malaria mortality reduction and elimination world-wide. 

This effort is in support of the Malaria Biologics Branch (MBB) at WRAIR to develop a highly efficacious biologic as an effective medical countermeasure to combat malaria. Parsons’ personnel supporting MBB will work on biochemical and molecular methods to better understand and improve the efficacy of different candidates, including the original RTS,S vaccine. Our R&D project teamworking exclusively onsite at WRAIR will provide technical expertise and related laboratory support services, data analysis, regulatory requirements reviews, and compliance with the biosafety and related regulations as part of the laboratory operational activities. Parsons’ team members will procure laboratory reagents, chemicals, assay kits, and other biologics from external vendors. Our laboratory support team will provide routine serology data readouts in support of pre-clinical experimental animal studies and clinical studies.

Responsibilities:
a.    implement quality control procedures for assaying purity, integrity, stability and potency of the GMP manufactured vaccine products;
b.    maintain the calendar for product testing to ensure FDA requirements for stability potency testing are met;
c.    coordinate testing of GMP produced vaccine candidates to ensure stability;
d.    review supportive testing results for vaccine products;
e.    prepare drafts of appropriate toxicology study protocols and review final reports;
f.    assist in acquiring and submitting all required documentation to the Scientific Review Committee and  Institutional Review Board;
g.    assist in preparation of IND and other regulatory documentation;
h.    advise and monitor  financial aspects of clinical projects, including budget development, milestones and deliverables timeline, and financial reports;
i.    assist in writing the Cooperative Research and Development Agreement’s (CRADA) and Clinical Trial Agreement (CTA);
j.    coordinate and write reports, work plans and scopes of work for clinical projects;
k.    manage scheduling and planning of meetings, including compiling and organizing relevant background materials, preparing minutes, and monitoring follow-up activities;
l.    maintain records, including paper and electronic files;
m.    assist in production of oral and written presentations;
n.    develop timelines for vaccine candidates through phase 2 clinical trials;
o.    assist in preparing presentations to potential funders;
p.    provide assistance with all job-related progress reports/technical reports; and
q.    support a safe workplace ensuring awareness of and observing appropriate safety and occupational health rules and regulations. The contractor is required to attend safety training relative to efforts in this task and report any infractions of safety procedures to the facility Safety Officer.

Minimum Education: BS degree in the life science discipline.

Minimum Experience: 3 years of experience with regulatory procedures related to clinical trials, human and animal use protocols.

Knowledge Base: Knowledge of regulatory procedures related to clinical trials, human and animal use protocols. Abilities related to vaccine product development, GMP manufacture, QA/QC release testing and preparation and filing INDs to the FDA, and final reports.

Parsons Healthcare delivers the resources to ensure the success of our federal customers’ missions around the globe. The services we provide help our customers in the area healthcare research and development, healthcare infrastructure, and healthcare related Information Technology and Cyber security.  We provide the right people with the right skills to ensure mission success.
 
 

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