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Food and Drug Administration Regulatory Technical Project Manager 6 Lorton, VA

Watermark Risk Management International has an exciting opportunity for a qualified Chemical & Biological Defense Technical Project Manager with industry experience in research and development with an emphasis on quality assurance and Food and Drug Administration (FDA) regulatory compliance. The candidate will support the Advisory and Analysis Services (A&AS) contract with the Defense Threat Reduction Agency (DTRA) Chemical and Biological (CB) Department.

Requirements:

  • Experience with process development, manufacturing development and/or clinical development
  • Detailed knowledge of and practical experience with FDA regulatory requirements for pre-clinical through Phase I clinical trials
  • Excellent communication skills for interface with customers and with team members
  • Familiarity with FDA approval and or licensure requirements and processes, including the implications of the FDA’s Animal Rule guidance

 In this role, as a Subject Matter Expert, you will:

  • Provide A&AS support to the Government with Medical Science, Quality Assurance and FDA Regulatory compliance
  • Possess extensive knowledge of United States FDA regulations and standards, especially relating to pre-clinical and pre-IND manufacturing, cGMP processes, and/or design and execution of Phase I Clinical Trials
  • Review and provide written and verbal guidance to Science and Technology Managers (STMs) on scientific proposals’ suitability for funding
  • Produce written technical analyses of the rationale, estimates and information behind proposed costs for proposals submitted by academic, military, and industrial laboratories
  • Review and provide regulatory guidance to STMs on reports and data packages provided by contracted organizations and government laboratories on the progress of funded research (cost, schedule and performance)
  • Provide advice on courses of action and assist with preparation of reports and briefings to senior government officials
  • Participate in coordinating interdepartmental activities and research efforts
  • Assist government staff with drafting critical documents and responding to taskers
  • Maintain current understanding of the rapidly evolving scientific advancements relevant to the Team’s portfolio of projects and advise government staff on advancements

Education:

  • Bachelor of Science plus 20 years of relevant experience, MS or MBA plus 18 years of relevant experience or Doctorate plus 15 years of relevant experience in at least one of the following disciplines: biomedical, medicinal chemistry or closely related science discipline

Security Clearance:

  •  Active and current Secret Clearance required

Preferred Qualifications:

  • Regulatory Affairs Certification (RAC)
  • Prior experience working with or for the FDA on drug approval
  • Prior experience with the development of animal models used in drug development
  • Familiarity with portfolio management
  • Understanding of the advanced development processes
  • Understanding of government contracting and acquisition processes
  • Familiarity with scientific program development, planning, programming and reporting

Watermark Risk Management International, LLC is an Equal Opportunity and Affirmative Action Employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factors.

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