Keoni Henthorn

Skills

• Proficient knowledge of Federal, State, and industry regulations with product category
compliance. EPA FIFRA (40 CFR §156.10) labeling requirements EPA FIFRA Section
3 & Section 25(b) product regulations State laws and regulations for product and
license registration requirements AAPFCO approved definitions and terms Organic
agency product listing requirements (OMRI, CDFA, and WSDA) HCS / GHS
regulation for SDS management
Balance Sheet and Profit & Loss (P&L) restructuring and management to comply
with indirect cost pools.
• GAAP, FAR, GSA, SOX, Prevailing Wage, Certified Payroll, DPAS, DCAA, DCMA,
IAS, ITAR, GSA, DOT, and Quality Control record-keeping compliance requirements
and protocols.
• Review and Negotiate Contracts and Complete Estimates, Bids, Grants, RFQ, RFP,
QA/QC, Gantt reports, and highly complex, technically demanding proposals, while
decreasing liabilities and increasing profits by optimizing cost pool methods.
Train and manage Personnel in accurate and expeditious methods that result in
positive union audits, DCAA, DCMA, DPAS, FAR, OSHA, ISO, FDA, and various
audits and clinical trials.
• Identify Probable Pitfalls in Current Procedures and the most successful methods of
decreasing that risk in the most time-efficient ways.
• Regularly monitor and maintain compliance with all relevant healthcare laws and
regulations, including HIPAA, ISO, CCPA, and CPOM, by developing, implementing,
and maintaining an effective compliance program
• Highly experienced working in Electronic Data Capture Systems In-depth
understanding of database structures and clinical workflows Experienced in database
programming and eCRF configuration Knowledge of clinical data standards such as
CDISC CDASH/SDTM Familiarity with GCP, ICH, and GCDMP Understanding of
FDA 21 CFR Part 11, HIPAA, GDPR, Annex 11 Familiarity with coding dictionaries
• Provide strategic oversight of product value demonstration and evidence generation,
maximizing health economics outcomes and developing value dossiers with Medical
Affairs. Monitor and educate on industry trends, regulatory changes, and payer
policies impacting reimbursement and commercial goals. Collaborate with the Clinical
team to integrate market access and payer perspectives into product development
and clinical plans. Provide input on market access strategies, including Health
Technology Assessment (HTA) and health economics, and for international markets.
• Operations management, budget advisement, and Contract Negotiations. Write,
Negotiate, and Manage contracts and grants with NATO, NIDA, NIH, Poland,
Croatia, Israel, United States Military, and other international and national
governments and universities.
experience
Swift Engineering | San Clemente, CA 2022 - Current
Senior Manager
• • Contract review, audits, and compliance advisement and oversight while working with
project managers and legal counsel on various aerospace, government design, and
951-760-6750
W: keoniworld@gmail.com
skills
• • Specialized Compliance
• • Collections & Skip Tracing
• • Contract Evaluations
• • Operations Management
• • Human Resources
• • Credential Compliance
• • Data Interpretation
• • Financial Management
• • Business Development
• • Quality Control
• • Program Management
• • Contract Management
• • Growth management
• • Marketing
• • Strategic Planning
• • Business Planning
• • Media Relations
• • Risk Management
• • Auditing processes
• • Internal Controls
• • Regulatory knowledge
• • Resource Allocation
• • Policy Development
• • Critical Thinking
• • Process Improvement
• • Proposal Writing
• • Technical Writing
• • Financial Analysis
• • Variance Analysis
• • General ledger accounting
• • Account Reconciliation
• • Data Analytics and statistics
• • Software Codes
• • Procedure Implementation
K

About

My focus lies in blending project management with compliance, leveraging my proficiency in contracts and accounting to navigate the complexities of engineering, government, aerospace, and medical sectors.

My achievements at Swift Engineering underscore a commitment to excellence in contract negotiations and risk minimization, empowering the organization to secure and manage pivotal projects with precision while navigating the complexities of stringent compliance.

With a career marked by strategic business development and a keen eye for regulatory adherence, my contributions have consistently fostered organizational growth and profitability.

My expertise in marketing communications further enables me to articulate value propositions clearly, while my command of multiple languages enriches our collaborative efforts across diverse teams and international partners.

Some of the compliance I've worked within have been:

1. EPA FIFRA (40 CFR §156.10)
2. 49 CFR, ICP, FAR, FDA, DCAA, DCMA, FDA, ITAR, GSA and DFAS / DPAS, ISO, NIST
3. GAAP, SEC, SOX, DAVIS BACON, Certified payroll,
4. CDISC CDASH/SDTM, GCP, ICH, GCDMP, FDA 21 CFR Part 11, HIPAA, GDPR
5. DOT, OSHA, CCPA, and CPOM, eCRF