Anne Baker Email & Phone Number

San Diego, California, Us

Facilitate business objectives and manage risk by providing practical, timely and effective legal support and high-quality guidance on diabetes technology company’s government and regulatory compliance, quality systems management, licensing, trade compliance, patient access, coverage and reimbursement including Medicare/Medicaid. Manage company’s product liability claims. Develop, modify, and execute company policies. Conduct training throughout organization on legal and regulatory compliance. Review and revise annual and quarterly SEC filings. • Influential business partner recognized for innovative approach to recent commercial launch with respect to promotional and educational materials and end-user samples. • Recognized as collaborative business partner.

Boston, Ma, Us

Supported biotechnology, medical device, pharmaceutical and healthcare clients with their legal needs.

Minneapolis, Mn, Us

Provided responsive, practical legal advice and support throughout lifecycle of medical devices - development through commercialization. Counseled, advised and trained on all matters facing medical technology company. Supported Digital Health and AI teams. Extensive knowledge of FDA, fraud and abuse, antikickback, HIPAA, FCPA, trade compliance statutes and regulations. * Subject matter expert : promotional review, reimbursement, prior authorization, privacy, data use and government affairs. * Recipient of numerous accolades and awards from business colleagues.

Provided legal advice and guidance on a wide variety of legal and compliance matters to medical device and nonprofit healthcare clients including telemedicine, clinical research, HIPAA, Stark, off-label, and antikickback as well as employment, litigation, corporate governance and tax . * Drafted and negotiated various sophisticated contracts including clinical trials, technology, M&A and dissolutions.

Established the first US legal department with international responsibility providing counsel and guidance on all legal, IP, regulatory and compliance matters. * Settled 5 outstanding lawsuits resulting in significant savings, ensured that 99% of employees were trained in ethics and compliance and reduced contract process time with the use of template documents. * Developed approach to maintain and defend IP with scarce resources. Implemented enforcement actions against third parties engaged in infringement activities.

Us

* Collaborated to develop and execute a financial and business turnaround within 8 months resulting in significant debt reduction, improved governance and transparency of operations, and an innovative business model. * Forged strong relationships with key finders to garner support for business turnaround.

Humlebæk, Denmark, Dk

Created in-house legal department; promoted to also lead 2 business functions. Built customer centric legal and business teams. Managed critical functions that enabled FDA product approval and commercialization. * Collaborated with federal and state regulatory agencies resulting in competitive advantage and mitigation of potential compliance risk. * Drove legislative and policy development, M&A activities, and all aspects of building new North American headquarters facility obtaining over $9 million in tax credits.* Negotiated the termination of a long term lease resulting in savings of over $5 million.

Prior experience as litigator, tax attorney, adjunct professor and nurse.

J.D., Law

B.S., Finance