Senior Consultant-Medical Countermeasures (contingent)

Consulting DC, District Of Columbia


Description

HWC is looking for consultants with expertise in a wide variety of scientific, medical, technical and project management specialties for an exciting new contract supporting the Department of Health and Human Service’s office of the Assistant Secretary for Preparedness and Response – a public health preparedness and emergency response organization leading the nation in preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters. Successful applicants walk the line between business and technology, are intellectually curious, self-starters, and excel in ambiguous and changing environments.

This position is on-site in Washington DC.

What You Will be Doing:

  • Providing subject matter expertise in regulatory and quality affairs supporting Medical Counter Measure (MCM) development pathways
  • Providing regulatory and quality assurance expertise on pathways for the successful review of ASPR procurements requiring regulatory clearance through other agencies, such as the Food and Drug Administration
  • Advising on innovative regulatory and quality assurance approaches for the successful development, licensure, manufacture and distribution of drugs, medical devices and/or products, and therapeutics
  • Advising ASPR leadership on critical regulatory challenges
  • Training and advising ASPR leadership on regulations, authoring regulatory documents, and interactions with regulatory authorities
  • Supporting the development of new regulatory policies and procedures in support of government Broad Agency Announcements (BAAs) and other ASPR innovation efforts, helping develop BAAs, and providing technical review of resulting white papers and proposals
  • Working as part of a high-performing, multi-company team at multiple locations (government client sites, company offices and work-from-home)
  • Quickly building and maintaining effective working relationships with government points of contact and other HWC teammates.
  • Traveling on official business as required
  • Must have received or be willing to receive the COVID-19 Vaccination by the date of hire to be considered.  Proof of vaccination is required.

Most Relevant Skills:

  • Program/project management
  • Stakeholder outreach and engagement
  • Consulting and problem-solving

Required Qualifications:

  • PhD and 4-6 years’ experience in biology, biostatistics, epidemiology, clinical investigation, medicine, chemistry, or pharmacy (or Master’s degree with additional experience)
  • US Citizenship
  • “Clean” criminal and financial/credit record enabling a successful U.S. government “Public Trust” background investigation

Preferred Qualifications

  • At least 10 years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry
  • Experience supporting the successful regulatory clearance of a drug, medical device and/or product, or therapeutic through the FDA
  • Familiarity with innovative government programs
  • Ability to research, learn and use various business systems and tools

About HWC

  • HWC believes in changing the world for good. We are a multidisciplinary firm headquartered in Washington, DC that helps mission-driven partners inside and outside government create meaningful, durable change.
  • We also believe in creating a vibrant culture where our employees can collaborate, explore new ideas and grow professionally. Specialized communities of practice, a flexible career growth model, social gatherings, philanthropic initiatives, virtual brown bags, and numerous grassroots initiatives complement a comprehensive benefits program designed with our employees’ needs in mind. HWC is a welcoming community that is stronger because of our team’s diverse backgrounds and experiences. Visit https://www.hwcinc.com/life-at-hwc/ to learn more about being part of HWC. 
    EOE M/F/D/V