Mary Morgan

About Mary Morgan

A regulatory professional who has overseen pharmaceutical regulatory affairs, quality control, safety, and compliance in the pharmaceutical, natural product, and medical device industries for 10+ years. Thorough understanding of drug development process, the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends · Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishmentI have held director and senior manager roles in regulatory affairs, quality control, safety, and compliance in the pharmaceutical, natural product, and medical device industries for 10+ years. I have developed broad leadership skills related to policy formulation, strategic planning, budget oversight, licensing, inspections/audits, and the ability to manage scientific/technical teams. I have also gained broad understanding of global standards for the industry as well as their relations to best practices (GMP, GVP and GCP). This background has given me the ability to learn new roles quickly and make an immediate impact. I am confident that this combination of skills and experience will make me a valuable member of your team. Specialties: Regulatory Affairs, Risk Management, Risk Communications, Good Manufacturing Practices, Good Clinical Practices, ICH, Health Canada and FDA regulations and guidelines Drug shortage management, Clinical Trials, Pharmacovigilance, Database Management, Drug Safety, Pre-market drug safety surveillance, Business Transformation,

Experience

1. Sr Program Manager, Defense Production Act

   Hhs Administration For Strategic Preparedness And Response

   Jun 2024 — Present · Washington, DC, US

   Provide program and project management support and subject matter expertise as it relates to the successful development, manufacturing, licensure, and distribution of drugs, medical devices and/or products, biologics, therapeutics, and other medical counter measures as required.Manage and provide direction for all aspects of program performance (i.e, technical, contractual, administrative, financial, etc.).Provide leadership to the technical and acquisition teams, ensure conformance to performance requirements, and assist in the overall direction to all project level activities and personnel.Conduct program research/analysis and development

Education

• University of Ottawa

  B. Sc., Biopharmaceutical Science

  2000 — 2004

• MGH Institute of Health Professions

  M.Sc., Clinical Investigations/Epidemiology/Public Health

  2006 — 2008

Skills

• Biochemistry
• Infectious Diseases
• Research
• Project Planning
• Database Management
• Life Sciences
• Clinical Development
• Strategic Communications
• Biotechnology
• Oncology
• Policy
• Risk Management
• Statistics
• Project Management
• Cell Biology
• Public Health
• Gcp
• Pharmacology
• Medical Writing
• Pharmaceuticals
• Government
• Pharmacovigilance
• Public Policy
• Gmp
• Compliance and Enforcement
• Database Admin
• Business Transformation
• Regulatory Compliance
• Pharmacoeconomics
• Compliance
• Epidemiology
• Clinical Research
• Regulatory Affairs
• Lifesciences
• Pharmaceutical Industry
• Fda
• Drug Safety
• Clinical Trials
• Scientific Writing
• Compliance and Enforcement