Kate Godfrey

About Kate Godfrey

Received my concentration in health law in law school and have 20 years of experience in healthcare compliance in the hospital, medical device, diagnostics, pharmaceutical and biotech settings. Highly effective at building and driving forward compliance departments, leveraging key internal and external partnerships, stakeholder management and providing innovative and practical solutions to increase corporate profitability with integrity. Results-oriented style with a proven track record of creativity, flexibility, and strategic leadership. Published articles and presented globally on various fraud and abuse, compliance and ethics, and privacy issues. Excel in engaging key external stakeholders to drive awareness and broaden understanding of business model(s) and suite of services as it relates to fraud and abuse policy-related matters and federal and state privacy issues impacting business.SpecialtiesHands-on professional with proven experience in:• Leading process and functional compliance audits• Developing field monitoring programs• Resolution of privacy and compliance-related Investigations• Drafting, training on and implementing policies and procedures• Collaborating with Global business partners in over 150 countries and providing expertise on requirements for interactions with US Healthcare Professionals• Responding to government investigations and implementing CIAs• Building a data analytics system • Brand attorney for promotional review committee• Drafting and negotiating contracts with HCPs, Patients, clinical trial agreements, sponsorship agreements, SOWs for third-party vendors related to brand activities, DPAs, and BAAs • Educational, Promotional and Corporate Grants, Donations and Sponsorships• US and Global Compliance Training to Sales, Marketing, Medical Affairs and Research and Development Functions• Product Development Activities (protocol development, IRB submission)• Ownership and responsibility for the Code of Conduct• Implementing federal and state transparency requirements, including Open Payments attestation• Compliance with HIPAA, GDPR, CCPA/CPRA and other applicable privacy regulations • Overseeing privacy for a HIPAA Covered Entity• Cultivating relationships with Trade Associations and advocating for organization\'s objectives• Adept at converting company policy positions into advocacy strategies to advance company legislative and policy interests

Experience

1. Senior Vice President, Global Chief Compliance Officer, Chief Compliance Officer Ksna

   KARL STORZ

   Jul 2024 — Present · El Segundo, CA, US

Education

• Society of Corporate Compliance and Ethics

  Certified Compliance and Ethics Professional

  2008

• California Western School of Law

  JD, Health Law

  2003 — 2005

• DePaul University

  B.S., Physical Therapy

  1997 — 2000

• Seton Hall University School of Law/ SciencesPo

  European Healthcare Compliance Ethics & Regulation Programme Certification

  2014

Skills

• Regulatory Submissions
• Clinical Development
• Clinical Trials
• Biotechnology
• Lifesciences
• Software Documentation
• Medical Compliance
• Life Sciences
• Cross-Functional Team Leadership
• Medical Affairs
• Healthcare
• Oncology
• Policy
• Auditing
• Training
• Management
• Pharmaceutics
• Regulatory Requirements
• Contract Negotiation
• Pharmacovigilance
• Program Management
• Quality Auditing
• Litigation
• Pharmaceutical Industry
• Fda
• Medical Devices
• Clinical Research