GH

GH

Director, Screening Compliance

Remote - Open Position (USA) · Director

Sponsorship not specified$218k-$299kDetected 30 days ago
Clinical TrialsClinical ResearchPatient CareClinical Laboratory TechniquesMedical DevicesResearchCommunicationCollaborationProblem Solving

About the role

  • Experience in a healthcare organization providing legal advice on contractual arrangements with referral sources for designated health services (DHS).
  • Specific prior experience in the development/deployment of compliance programs, including all seven elements of the OIG recommended program for clinical laboratories.
  • Solid understanding of industry best practices for ethics and compliance risk within the healthcare diagnostics industry

Responsibilities

  • Provide specialized legal counsel and strategic advice on a wide range of compliance issues to support the development and commercialization of cancer screening test products
  • Developing a keen awareness of risks associated with the marketing and sale of cancer diagnostic products to proactively address issues and identify opportunities for process improvements
  • Provide guidance with an eye towards problem-solving to business partners and key stakeholders through all stages of the product life cycle
  • Draft, implement and maintain relevant policies, procedures, work instructions, and training plans related to risk areas
  • Perform routine teaching audits of high-risk functional areas to assess and improve training effectiveness
  • Manage the lifecycle of corrective actions and remediation plans that address compliance-related deficiencies in processes, procedures, and other operational activities
  • If you need support, please reach out to Peopleteam@guardanthealth.com
  • We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires.

Requirements

  • Training and presentation experience in various settings including live audience and video conferencing
  • Ability to articulate risk without being an "alarmist"
  • Ability to travel, on occasion (~15%)
  • Assist with internal investigations, as required, to promote a culture of zero tolerance for non-compliance, with heightened focus on timely follow up on incoming inquiries and complaints
  • Employee may be required to lift routine office supplies and use office equipment.
  • A background screening including criminal history is required for this role.

Nice to have

  • Knowledge of privacy laws (federal and state laws) a plus

Compensation

  • $217,600 - $299,200Other
  • $217,600 - $299,200If the role is performed in
  • $230,400 - $316,800

Benefits

  • Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer.
  • This range does not include benefits or, if applicable, bonus, commission, or equity.

Equal opportunity

  • All your information will be kept confidential according to EEO guidelines.

This listing is sourced directly from GH's careers page and normalized into a canonical job model.