Are you looking for a Challenge? Looking for an innovative organization and the opportunity to learn and grow professionally? Our client is currently seeking a Life Sciences Subject Matter Expert. The ideal candidate will support a centralized, comprehensive regulatory compliance assessment program for a U.S. Department of Homeland Security (DHS) client with responsibilities spanning: life sciences research, research and development (R&D) compliance facilitation, training, and policy support. This position is onsite in Washington DC or offsite with travel.

In this role you will be expected to:

  • Review life sciences research activities to ensure federal regulatory and standards compliance with relevant federal policies to include those involving biological agents and related materials (biosafety and biosecurity) and animal care, use, welfare, and research.
  • Confirm performing organizations operate under suitable biosafety plans, procedures, and assurance of compliance and the appropriate biosecurity measures have been implemented in accordance with federal requirements and DHS policy.
  • Confirm performing organizations conducting or supporting research that is not exempt from the purview of the Common Rule are operating under an active and approved Assurance of Compliance.
  • Identify institutional Dual Use Research of Concern (DURC)
  • Conduct site visits and/or documentation reviews to coordinate regulatory requirements and evaluate compliance status.
  • Coordinate with DHS entities responsible for safety, medical, and environmental issues to ensure departmental integration in compliance assurance efforts.
  • Facilitate and support client involvement and participation in relevant intradepartmental and interagency groups.
  • Review and coordinate on the approval of animal protocols involving nonhuman primates and human subjects.
  • Ensure research involving human subjects has received all applicable regulatory and/or compliance approvals.
  • Manage documentation requirements, reports, and risk mitigation plans, and support data collection and reporting.
  • Ensure timely entry of information into a compliance database.
  • Support outreach program to sensitize program managers and researchers to Federal compliance requirements.
  • Assist in the identification of new compliance requirements and development of corresponding processes.

Required Qualifications:

  • Bachelor’s Degree with 4+ years, or a Master’s Degree with 2+ years of related experiences in a Business / Management related field or a related technical field such as Engineering, Physical, Life or Social Sciences, Physics, Mathematics, or Computer Science
  • Demonstrated knowledge in life sciences, biosafety, biosecurity, biodefense, or related subject areas.
  • Familiarity with DHS regulatory compliance monitoring, regulations, standards, and guidelines for biosafety, biosecurity and Biological Select Agents and Toxins (BSAT), Animal Care and Use (ACU), the Human Research Protections (HRP) and life sciences Dual Use Research of Concern (DURC), and other legal and/or policy initiatives or developments in the area of life sciences.
  • Familiarity with compliance with U.S. arms control agreements, in particular the Biological Weapons Convention and the Chemical Weapons Convention, and compliance with multilateral and U.S. export controls, such as the Export Administration Regulations (EAR); the International Traffic in Arms Regulations (ITAR); Office of Foreign Assets Control (OFAC) regulations; and various multilateral regime.
  • Experience providing support within a professional environment.
  • Ability to adapt quickly to changing priorities.
  • Experience building and managing client and stakeholder relationships.
  • Experience working with or for the federal government.
  • Excellent communication and writing skills.
  • Active Secret Clearance

Preferred Qualifications

  • Current DHS Suitability
  • Familiarity with:
    • DHS capability development programs and processes
    • Department of Health and Human Services (HHS) recommendations for standards, practices, equipment, and facilities presented in Biosafety in Microbiological and Biomedical Laboratories
    • Select Agent Regulations, the Animal Welfare Regulations, other animal care and use related guidelines
    • National Institutes for Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, and other related guidance
    • Public Health Service Policy on Humane Care and Use of Laboratory Animals, USDA animal welfare requirements, and other applicable regulations, standards, and guidelines
    • Center for Disease Control (CDC), the United States Department of Agriculture (USDA), and regulations such as 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 221
    • NIH Office of Laboratory Animal Welfare (OLAW) and Office for Human Research Protections (OHRP)
    • The Common Rule and 6 CFR Part 46 (the DHS codification of the "Common Rule.")
  • Proactive personality with the ability to sequence tasks in order of terms of importance; and willingness to pivot if more important tasks arise
  • Ability to collect and analyze relevant information, problem-solve, and make rational decisions
  • A desire to work within a collaborative team environment and a natural ability to build honest and respectful relationships with clients and colleagues
  • Excellent writing skills with an ability to synthesize, be concise, use the active voice, proofread, and edit

All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, age, marital status, ancestry, protected veteran status, or any other protected group or class.

DILBERT © 2018 Scott Adams. Used By permission of ANDREWS MCMEEL SYNDICATION. All rights reserved.