Summary
Overview
Work History
Education
Skills
Affiliations
Additional Information
Timeline
Volunteer

HEATHER D HOWELL

Frederick,Maryland

Summary

EXEC SUMMARY Strategic leader with proven success building high-performing teams and promoting collaboration, inclusion, and diversity. Forward-thinking executive adept at optimizing performance, driving profitability, and transforming organizations. Results-driven advisor proficient at interpreting global medical product regulations from preclinical to commercialization. Demonstrated expert in regulatory strategy, risk communication, global compliance training, change and crisis management. Passionate public health and patient advocate experienced in building strategic partnerships and stakeholder relationships. Strategic problem-solver, change manager and visionary executive with success implementing plans to meet current and future needs. Key expertise in MedTech, Pharma Biotech and Consumer Health products.

Overview

35
35
years of professional experience

Work History

President / Principal Consultant

HDH SOLUTIONS GROUP LLC
10.2023 - Current
  • Provide expert professional services to clients across the global health sciences sectors
  • Improve performance and achieve compliance, cost savings, and profitability
  • Deliver innovative training and global regulatory and go-to-market strategies
  • Provide crisis management, risk communication, and patient safety programs
  • Support mergers and acquisitions through due diligence and integration plans


Senior Director, Growth / Senior Advisor

NSF INTERNATIONAL
11.2022 - 09.2023
  • Executed Go-to-Market and growth strategies for business units
  • Reorganized and aligned Sales and Marketing functions for efficiency and industry focus
  • Recruited and directed 15 strategically located global Sales & Marketing Executives
  • Secured NEW sales of $24M year-1 / $40M year-2 (of Division’s $85M-$100M revenue)
  • Promoted accountability by establishing commercial KPIs, performance metrics, and evaluations
  • Retaining key sales talent and Increased employee satisfaction by 28% over prior year
  • Established sales goals aligned with regional pricing models, revenue targets and market research
  • Implemented regional sales polices aligned with technical capabilities and cultural considerations
  • Implemented Salesforce CRM across seven specialized global businesses to achieve $250K savings
  • Directed market research and budget formulation for aggressive growth in China
  • Directed rebranding efforts for NSF's acquired clinical research organization (CRO)

Global Vice President

NSF INTERNATIONAL
01.2022 - 11.2022
  • Direct report to CEO, advisor to Board of Directors, NSF Executive Leadership Team member, and Division Head for six global Consulting, Training, Certification businesses
  • Provided interim leadership and crisis management to stabilize the global workforce of 200+ specialized experts in the wake of sudden change, disruption, and financial setbacks
  • Implemented corrective actions to achieve $85M revenue with 35% profit margins
  • Directed development of a 5-year strategic plan, prioritizing talent management, operational excellence, acquisition integration and new business
  • Maintained top talent realizing 7% attrition through increased communication and recognition
  • Retained ALL key clients across six global health sciences businesses during my tenure
  • Secured resources and removed administrative and operational barriers for business leaders
  • Enhanced employee productivity and increased satisfaction scores by 22% by launching the Culture-of-Collaboration initiative

Executive Vice President

NSF HEALTH SCIENCES, Global Training Solutions
07.2016 - 01.2022
  • Launched B2B and B2C Training, directing operations, product development, sales, and service delivery
  • Executed global business plans and product-specific pricing, sales, and marketing strategies to achieve $10M revenue for Training services - increased to $54M with addition of NA Consulting in 2022
  • Recruited and directed a diverse technical and creative design team, ensuring high quality content and interactive instructional design
  • Partnered with external service provider to build a world-class digital eLearning program and a customized cloud-based LMS, securing $2M eLearning revenue within 18 months of launch.
  • Established global eCommerce policies related to taxing, reporting and intellectual property
  • Directed conversion of the full portfolio of classroom training to the virtual classroom, maintaining vital revenue during the pandemic.
  • Provided expert client consultation as individual contributor, averaging $1M personally attributable revenue YOY

Deputy Director

FOOD AND DRUG ADMINISTRATION
03.2006 - 07.2016
  • Directed programs and 160+ employees responsible for risk communication, regulatory education and internal communication
  • Cultivated relationships with patient and trade groups and international regulators to improve patient/consumer awareness
  • Oversaw $21.3M budget ($19.7M Appropriated, $1.6M User Fees), participated in critical MDUFA funding negotiations
  • Ensured all CDRH communications incorporated scientific and regulatory perspective and aligned with Dept/Agency policy
  • Oversaw message distribution technologies including 4,000+ web pages, social media channels, TV studio and post-production facility
  • Secured funding and oversaw training and professional development programs for 1700+ CDRH employees
  • Chaired multiple Agency, Center and Public-Private Partnership Committees and co-authored publications to improve public communication
  • Partnered with industry associations to develop novel education and resources for the regulated industry
  • Moderated live broadcasts and FDA-Industry panels to reach 5000+ per event
  • Directed implementation of Mammography Quality Standards Act (MQSA) and Radiation-Emitting Products regulations
  • Chaired CDRH Management Committee, governing operational improvements and employee recognition programs
  • Co-authored the CDRH Safety Signal Escalation Guidance document
  • Oversaw Speaker Requests and Public Meeting coordination
  • Executed Emergency Response Comms Plan and Continuity of Operations (COOP)

Public Health Advisor & Special Duty Assignments

FOOD AND DRUG ADMINISTRATION
01.1989 - 01.2006
  • Early career included various professional roles of increasing authority implementing the Federal Food Drug and Cosmetic Act (FD&C)
  • Special Duty Assignments in executive roles included (Acting) Deputy Regional Director of ORA NE Region and (Acting) Asst Deputy Commissioner for External Affairs

Education

Master's Certificate - Organizational Leadership

George Washington University
Washington, DC

Master’s Certificate - Project Management Professional

GEORGE WASHINGTON UNIVERSITY
Washington, DC

Bachelor of Science - Behavioral Science

UNIVERSITY OF MARYLAND
College Park, MD

Skills

  • Regulatory Strategy
  • Executive Leadership
  • Strategic Communication
  • Commercial Excellence
  • Training Technologies
  • Operational Excellence
  • Patient Advocacy
  • Relationship Building
  • Strategic Planning
  • Crisis Management
  • Risk Mitigation
  • Sales and Marketing

Affiliations

  • Federal Executive Institute Alumni Association (FEIAA)
  • Association for Advancement of Medical Instrumentation (AAMI)
  • Regulatory Affairs Professionals Society (RAPS)
  • Professional Women's Network Association
  • Worldwide Women’s Network
  • FDA Alumni Association
  • Clover Hill Architectural Review Committee (ARC)

Additional Information

AWARDS AND HONORS

  • FDA Outstanding Service Award
  • FDA Commissioner's Special Citation
  • FDA Leveraging and Collaboration Award
  • John C. Villforth Leadership Award
  • Lireka P. Joseph Award for Public Health Communication


Timeline

President / Principal Consultant

HDH SOLUTIONS GROUP LLC
10.2023 - Current

Senior Director, Growth / Senior Advisor

NSF INTERNATIONAL
11.2022 - 09.2023

Global Vice President

NSF INTERNATIONAL
01.2022 - 11.2022

Executive Vice President

NSF HEALTH SCIENCES, Global Training Solutions
07.2016 - 01.2022

Deputy Director

FOOD AND DRUG ADMINISTRATION
03.2006 - 07.2016

Public Health Advisor & Special Duty Assignments

FOOD AND DRUG ADMINISTRATION
01.1989 - 01.2006

Master's Certificate - Organizational Leadership

George Washington University

Master’s Certificate - Project Management Professional

GEORGE WASHINGTON UNIVERSITY

Bachelor of Science - Behavioral Science

UNIVERSITY OF MARYLAND

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