Kate Godfrey, Jd, Ccep Email & Phone Number

Seattle, Wa, Us

Tuttlingen, Bw, De

Tuttlingen, Bw, De

I am accountable for overseeing compliance within the Americas region, and ensuring compliance with laws, regulatory requirements, policies, and procedures.As the Regional compliance leader for KARL STORZ, I am responsible for establishing standards and implementing procedures to ensure that the compliance programs throughout the organization are effective and efficient in identifying, preventing, detecting, and correcting noncompliance with applicable laws and regulations.My key responsibilities include:- Defining the necessary level of knowledge on existing and emerging regulatory compliance requirements across the organization.- Developing the annual compliance work plan that reflects KARL STORZ’s unique characteristics.- Periodically revising the compliance plan in light of changes.- Guiding in a productive, professional way, the compliance teams.- Overseeing and monitoring the implementation of the compliance program.- The implementation and management of the compliance data analytics program to further enhance monitoring, investigations, policy and business operations - Providing guidance, advice, and training.- Providing strategic direction to the management team on compliance.- Preparing and presenting clear and concise compliance reports to Leadership.- Interacting with regulators on compliance issues.- Coordinating efforts related to audits, reviews, and examinations.- Developing policies and programs that encourage managers and employees to report suspected fraud and other improprieties, without fear of retaliation.- Coordinating internal compliance review and monitoring activities, including periodic reviews of departments.- Independently investigating and acting on matters related to compliance.- Monitoring external review processes.

New York, Ny, Us

Women’s leadership organization

South San Francisco, Ca, Us

Position was eliminated. Primary oversight of Veracyte’s corporate compliance program and global privacy program as an Executive Team member. Responsible for the harmonization and building of both global compliance and privacy programs following the acquisition of two independent companies into the Veracyte organization.

Seattle, Wa, Us

Developed and executed Adaptive’s short- and long-term strategy to achieve the broader regulatory and policy changes necessary for our business, including framing and scoping key issues, stakeholder mapping, coalition building and maintenance; government relations and public affairs campaigns; content creation and distribution; and managing external specialists and consultants in policy matters related to fraud and abuse laws and data privacy. Designed, drove, and oversaw the implementation and operation of a robust company-wide corporate compliance program for Adaptive to prevent and detect noncompliance with laws and regulations, unethical behavior, and/or criminal conduct. Responsible for the entire compliance program cycle – ensuring systems are in place for establishing policies, procedures and other written standards, appropriate training plans and content, ensuring there is a system for asking questions on specific content, establishing and executing on monitoring plans, and overseeing the completion of any corrective actions (either identified through monitoring, auditing, investigations or regular policy reviews). Owned the contracting aspect for all agreements with HCPs, HCEs, patients, grants, sponsorships and donations, and any others that carry a fraud and abuse risk.Built and evolved a comprehensive privacy program governing the collection, use and disclosure of personal data, including PHI. Strategically advised on the development of products and services that anticipate and successfully navigate privacy considerations. Collaborated with business partners and lead contracting efforts on data privacy issues in contractual arrangements with third parties.

Seattle, Wa, Us

Represent the US Healthcare Compliance Office on regular global Healthcare Compliance Office meetings and tasks as assigned by the US Chief Healthcare Compliance Officer. Responsible for oversight and strategic management of the US obligations to review requests for engagement of US HCPs by ex-US affiliates and functions. Develop and maintain an IT strategy for the US Healthcare Compliance Office to support its compliance systems and communications. Lead the Healthcare Compliance Office communication and outreach efforts at key meetings and events such as the National Sales Meeting and Compliance Week. Chair of the Fair Market Value Steering Committee. Develop and deliver compliance training to Chugai US, Chugai Tokyo, Roche Welwyn and Commercial Business teams within Genentech.

Switzerland 🇨🇭 , Ch

Globally responsible for managing all aspects of healthcare compliance support within Global Product Development to ensure that all marketing, medical and study management activities are conducted in accordance to Roche’s Code of Conduct as well as all applicable global and local laws, regulations and self-regulation healthcare compliance codes. Provide leadership in the development and implementation of relevant policies, SOPs, guidelines and procedures in accordance with global and local regulations and laws, self-regulation codes of conduct, and ensure that all employees are trained. Provide Pharma-wide oversight and strategic direction related to Product Development health care compliance activities and ensure global cross-functional alignment, in close partnership with other Pharma functions. Globally responsible for development and implementation of compliance training to all Development employees. Global lead for query management for all healthcare compliance related queries. Drafted several guidance documents for the Development organization on multiple compliance topics to provide guidance and mitigate risk specific to their function. Lead and/or assist in healthcare compliance investigations of potential policy or code of conduct violations as related to Development employees.

South San Francisco, California, Us

Responsible for approving requests for the engagement of US HCPs from all Roche Affiliates; ensuring compliance with FMV guidelines, Genentech policies, and state and federal requirementsLead various audits to evaluate and minimize risk areas associated with off-label promotion and kickbacks; create and supervise corrective action plans to ensure appropriate corrective measures were enforcedConducted formal risk assessment of the Medical Affairs organization; identified policy gaps, and developed action plan to implement next steps and mitigate risk outliers

Dublin, Coolock, Ie

Responsible for total compliance oversight of independent medical education programs targeted at medical professionals, societies, Academic Medical Centers and Medical Education Communication CompaniesDeveloped and maintained policies, processes and procedures for Medical Education Department, Medical Affairs and US Healthcare Law Compliance Program and responsible for training relevant groups on policiesIdentified potential compliance violations, initiated investigations, educated and/or disciplined employees accordinglyManaged strategically focused initiatives while ensuring compliance with PhRMA, AdvaMed, OIG and ACCMEVoting member of Grant Review Committee and the Legal, Medical Affairs and Regulatory CommitteeCreated and implemented monitoring plan spanning the scope of Allergan functions in an effort to assess effectiveness of internal controls and monitor compliance with Allergan policies and applicable regulatory obligationsReviewed and approved all Advisory Boards and Charitable Contribution requests

Vista, Ca, Us

Initiated Compliance and Privacy Program assessments and developed implementation strategyEstablished Promotional Review Committee and Charter to address compliance risks such as off-label marketing Developed Vendor certification/registration process Engaged hotline company to develop internal reporting mechanismDrafted internal guidance regarding Conflict of Interest issues involving the Medical/Technical Advisory BoardsProvided guidance on HIPAA Privacy and Security regulations and its application to the Sales/Marketing divisions

San Diego, Ca, Us

Reviewed and recommend revisions to compliance policies and procedures, including Conflicts of Interest and Compliance Hotline; IRB policies and procedures, including Informed Consent, Operations, and Authority and Relationship; drafted new Gifts and Gratuities policy Tracked all hotline calls, oversaw investigations and ensured that the hotline database and responses were completed and accurate in a timely manner and created quarterly reports for the Board Developed management action plan in response to external compliance assessmentRevised the Code of Conduct (the revision was submitted to Corpedia for a High-Level Code of Conduct Assessment and received a benchmarking grade of A-) Formulated response and attachments to OIG regarding Sharp's third and fourth annual reports to the federal government under the Corporate Integrity AgreementHelped prepare documentation and evidence of compliance effectiveness for Malcolm Baldrige National Award on-site visit for 2006 and 2007, assisted in obtaining designation in 2007Revised Compliance and HIPAA/Privacy education for all students/registry employees and wrote annual compliance education and tests for all staff of 18,000+ employeesCreated system-wide marketing/communication plan integrating all elements of compliance programDeveloped compliance action plan advising on the practical implications of the Deficit Reduction Act of 2005 on health care providers, including potential revisions to system-wide education, policies, and codes of conductCreated and maintained a compliance webpage on the intranet and worked with the web team to make the information available on the internet

Jd, Health Law

B.S., Physical Therapy

European Healthcare Compliance Ethics & Regulation Programme Certification

Certified Compliance And Ethics Professional