Company Description|Job Description
Guardant Health is a pioneer in non-invasive cancer diagnostics & the first company tocommercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate & precise picture of the individual genomic alterations that cause tumors to grow, change, & develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, & our breakthrough innovation in liquid biopsy to create new tests that have already handled tens of thousands of samples. We believe our tests can accelerate new drug development & improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish & new uses of our platform are emerging.
We succeed best by coordinating our creative talents & energies to achieve results far beyond what any single individual could accomplish. We seek very talented people who want to be part of our fantastic team.
This position reports directly to the Chief Compliance Officer. The Compliance Program Manager is responsible for the management & execution of the company Compliance Program to oversee HCP interactions & engagements, monitoring practices within the organization, audits & investigations, privacy, transparency & international anti-bribery certification process.
Daily Compliance Activities:
- Responsible for the development, implementation, & ongoing improvement of the Compliance Program; provide guidance to company personnel on ethics, operational compliance & risk issues.
- Responsible for building & maintaining effective working relationships with internal & external stakeholders, including consulting with in-house legal staff as necessary to address compliance issues.
- Liaise with various departments & serve as an expert on compliance knowledge & guidance resource for the Company, providing education & training on fraud & abuse laws, including but not limited to the Stark Law, Anti-Kickback Statute, Federal False Claims Act, global privacy laws & state specific rules & regulations.
- Collaborate with international business partners & local counsel for adherence to international laws & regulations.
- Draft & maintain compliance policies & SOPs in accordance with evolving business needs & applicable regulations.
- Conduct compliance investigations from intake to resolution; collaborate with other functions to provide recommendations.
- Ensure corrective actions are adequate & are implemented for all identified compliance deficiencies.
- Develop & conduct educational sessions on various compliance-related topics; draft & implement policies & procedures.
Monitoring, Auditing & Risk Assessment Activities:
- Review terms for all HCP contracts; audit HCP engagement activities
- Investigate any reported or other detected compliance issues associated with HCP interactions
- Perform routine privacy compliance monitoring activities to ensure company wide compliance with HIPAA, GDPR, APPI & other privacy regulations in consultation with the Chief Compliance Officer & Security Officer
- Lead or support privacy related activities including response to internal/external access, disclosure, & permitted external/internal use of protected personal information
- Identify suitable third party auditors for internal & external audits (as needed)
- Be responsible for certain aspects of company wide risk assessment activities
- Four-year BA/BS degree; JD preferable
- Certification in healthcare compliance by a national association or similar accredited institution
- Bachelor's degree & post graduate degree (preferred); JD or Masters in Healthcare Administration.
- At least 8 years of specific compliance experience working either in a health care organization Compliance Department or in a related capacity.
- Working knowledge & understanding of regulations pertaining to Healthcare Compliance (AKS, False Claims, Stark, HIPAA, etc.)
- Knowledge of international privacy regulations including GDPR
- Experience in biotech, healthcare or medical device industries is preferred.
- Experience developing, implementing, & monitoring a compliance program.
- Experience with metrics used to measure success of the compliance program.
- Demonstrated experience identifying & resolving compliance issues.
- Previous global compliance oversight desirable
- Ability to work autonomously with limited direction
- Ability to maintain confidentiality of sensitive matters
- Excellent project management skills: can prioritize multiple tasks & goals to ensure timely, on target & within-budget accomplishment of such.
- Proven track record of effective decision-making: makes good business decisions & consistently exercises sound judgment. Applies sound judgment around escalation of issues.
- Excellent verbal & written business communication skills; ability to clearly & succinctly articulate position & rationale to others.
- Strong influencing skills: proven track record & experience building & cultivating relationships with key partners & stakeholders across organizational levels. Ability to manage conflict & negotiate corrective actions with cross-functional stakeholders.
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status & will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.
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