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Compliance Program Manager

Apply Share Job ID 1267 Category Corporate Functions Job Location Redwood City, California Posted Date 03/18/2019


This position reports directly to the Global Compliance Officer. The Compliance Program Manager is a high-level, global position in the Compliance Department. This role leads Compliance Department worldwide in HCP contracting, compliance investigations (including hotline reports, employee complaints and privacy issues), privacy, transparency and oversees the annual anti-bribery certification process. Additional responsibilities include developing and implementing approved policies and making recommendations for changes to existing Genomic Health's policies and procedures, ensuring alignment between GHI Corporate and International. The position is based out of our Redwood City, CA corporate office.


General Compliance Department Activities - Communications, Policies & Procedures:
· Establish and maintain relationships and collaborate with International Legal for interpretation, impact and adherence to international laws and regulations; take lead on pulling International requirements through to Global Compliance Team in RWC
· Provide ongoing guidance to business partners regarding compliance programs and procedures
· Draft new and propose updates to existing Compliance policies and SOPs in accordance with changing business requirements, laws and regulations

Monitoring, Auditing and Risk Assessment Activities
· HCP Contracting:
o Review Commercial HCP events, such as Speaker programs, Advisory Boards, Physician Experience Programs, Specimen Prep/Lab Services and others as directed, including reviewing requests, evaluating HCP credentials (as appropriate), preparing contracts, and handling compliance issues related to the programs/agreements:
? Fair Market Value analyses of HCP CVs for tier leveling and fee-for-service arrangements
? Prepare contract templates as necessary
? Review and approve HCP reimbursements for events in accordance with GHI policies, including assisting AP by reviewing HCP expenses as requested
? Investigate reported or detected compliance issues related to HCP programs
o Conduct periodic process audits of HCP events, services received under agreements and other activities as directed

· Privacy and Transparency
o Perform ongoing privacy and transparency compliance monitoring activities, as requested to ensure enterprise wide compliance with internal policies, rules and regulations pertaining to HIPAA and GDPR in consultation with the Global Privacy Officer
o Support the Global Privacy Officer in response to internal and external inquiries relating to access, disclosure, and permitted external/internal uses of protected personal information

· Anti-Bribery and Corruption (ABC)
o Drive cross-functional support to ensure successful launch and completion of the annual anti-bribery certification program
o Provide guidance and oversight to global team in Geneva on ex-U.S. anti-bribery programs
o Lead the selection of third parties for audit
o Collaborate with third party audit firms to design and implement ABC audits

· Risk Assessment
o Assess risk associated with applicable laws and regulations, such as U.S. Anti-kickback Statute, False Claims Act, Stark Law and similar ex-U.S.
o Own sections of the risk assessment process, specifically for International and as directed
o Contribute to the identification of enterprise risks
? Conduct and document the results of interviews
? Perform risk analyses including likelihood drivers and impact criteria
· Perform other monitoring, auditing and risk assessment activities as required, under the direction of the Global Compliance Officer

· Maintain confidentiality and integrity of all investigations
· Contribute to/lead investigation activities as directed
· Liaise with International Legal and HR, as needed, and provide investigation oversight to International
· Lead internal case review meetings for alleged violations and help determine next steps
· Partner with HR for investigation support
· Manage the investigation case lifecycle from intake to resolution; meet regularly with Compliance team members to obtain investigations' status
· Conducts trend analyses, track and report case metrics (including intake, alleged violations, discipline, etc.) and summarize results for internal reporting purposes (monthly and quarterly)
· Maintain objectivity and "seek to understand" attitude in investigations to determine root cause and mitigation and corrective action recommendations


· Four-year BA/BS degree; JD preferred; however, MBA with commensurate compliance experience acceptable; other certifications/licenses such as CFE or CPA a plus
· Certified in Healthcare Compliance by a national association or university (e.g., CHC designation or certification from an accredited law school such as Seton Hall), or the desire to obtain such within one year
· At least 8 years relevant work experience with an emphasis in compliance, auditing and/or investigations
· Previous global responsibilities desirable
· Requires limited direction to complete standard work
· Able to maintain confidentiality of highly private investigations and other matters
· Experience in drafting and interpreting legal agreements
· Experience conducting internal audits and managing recommendation outcomes, or equivalent work experience
· Experience conducting corporate internal investigations including intake, investigation, resolution and written summary reports, or equivalent experience
· Excellent verbal and written communication skills
· Proactive, highly responsive, collaborative, diplomatic, flexible and adaptive
· Ability to work independently and use good judgment while also collaborating frequently across departments
· Excellent communication and interpersonal skills as applied to interaction with coworkers, contractors, supervisors, healthcare professionals and others
· Self-starter without requiring hands-on supervision
· Ability to manage up and work well with executive team members

· Healthcare industry (e.g., diagnostic laboratory, medical device, pharma, biotech) experience
· Familiarity with applicable Federal, State, and local laws, rules and regulations of the healthcare industry (e.g., AKS, FCA, Stark and equivalent ex-U.S.)


This role leads Compliance Department in HCP contracting, compliance investigations (including hotline reports, employee complaints and privacy issues), privacy, transparency and oversees the annual FCPA certification process. Additional responsibilities include developing and implementing approved policies and making recommendations for changes to existing Genomic Health’s policies and procedures.
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!