Description
Qualifications
Required Qualifications:
- PhD in pharmacology, biology, microbiology, or relevant related field
- 10+ years of experience
- Subject matter expertise in pharmaceuticals, biostatistics, epidemiology, or clinical investigation
- U.S. citizenship
Desired Qualifications:
- 10+ years industry experience in pharma/biotech/diagnostics or PPE construction, manufacturing, or product development
- Federal civilian experience with HHS or an associated agency
- Previous experience involving grants administration in a Federal civilian environment
Please note that the salary information shown below is a general guideline only. Salaries are commensurate with experience and qualifications, as well as market and business considerations. Salary transparency pay range for the Washington, DC area: $130k-160k
Responsibilities
Support the ASPR Innovation efforts, including but not limited to all ASPR solicitation requirements and support the review of White Papers and Full Proposals. Provide subject matter expertise in supporting Medical Counter Measure (MCM) development pathways, the preferred areas of expertise include regulatory, engineering, facilities and infrastructure, large and small molecule CMC, or within the MCM areas of PPEs, diagnostics, or innovative manufacturing technologies. Provide support as a regulatory and quality affairs SME on pathways for the successful review of planned and known ASPR procurements that require regulatory clearance through other agencies, such as the Food and Drug Administration (FDA). Advise on innovative regulatory and quality affairs approaches for the successful development, licensure, and manufacturing and distribution of drugs, medical devices and/or products, and therapeutics as required. Advise ASPR leadership on critical programmatic and project-level regulatory challenges. Provide training and advisement to ASPR leadership on regulations, authoring regulatory documents, and interactions with regulatory authorities. Support other Contractors supporting ASPR & IBMSC efforts as required.
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