Helen Duda-Racki

About Helen Duda-Racki

MEDICAL INFORMATION - MEDICAL AFFAIRS - MEDICAL COMMUNICATIONS - MEDICAL OPERATIONSAccomplished executive who has been creating value for 25+ years building infrastructure in start-up to large size pharmaceutical and biotech companies. Recruits, directs, manages, inspires, mobilizes, and develops people, and creates charter with cohesive, collaborative, high performing teams to execute defined goals and deliverables. Efficiently leads and manages budget utilization and resource management, project prioritization, and forecasting. Operates as the medical bridge between the industry and wider medical community and laypersons. Provides scientific and clinical support and input for commercial products. Solid understanding of regulations, and oversees compliance with applicable federal, state, and corporate company standards/guidelines.CORE COMPETENCIESPharma/Biotech Start-up | Medical Information | Operations | Medical Legal Regulatory Review Committee | Medical/Scientific Communications | Strategic Roadmaps | Lifecycle/Launch/Business Plan Development & Execution in Support of Product Approval and Commercialization | SOPs Governance/ Compliance with FDA/OIG Guidelines/Regulations | Support Regulatory | Cross-Functional Team Player | Work with Key Stakeholders | Flexibility Working Across Different Therapeutic AreasSELECT HIGHLIGHTS• As head of medical information departments, strategically implemented medical information departments and contact centers in start-ups; restructured established departments with outsourcing and/or in sourcing to optimize performance.• With clear business acumen to recognize corporate business needs, developed, implemented, and executed strategic business plans for a new department (library/knowledge management services) and new committees, including Medical, Legal, and Regulatory Review Committee.• In alignment with clinical, regulatory, and marketing, participated in the development and execution of medical affairs plans, including lifecycle, launch, and global business plans and associated activities including publication planning, education programs, and conferences.• Implemented Medical Strategy Committee to oversee Medical Science Liaison (MSL) communications.• Authored the following: Curran CF, Sundar MN, Dieters AJ, Fierro L, Duda-Racki H, Patel M. Drug Information Coordination for a Copromoted Product. Drug Information Journal.

Experience

1. Executive Director, Global Medical Information

   Novavax

   Oct 2021 — Present

Education

• Saint John's University - College of Pharmacy; Fairleigh Dickinson University

  MBA; Pharmacy Degree, Business Administration, Pharmacy