Director, Compliance

Reposted 13 Days Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
Senior level
Biotech
The Role
Lead development and implementation of a comprehensive privacy program ensuring HIPAA and regulatory compliance. Oversee privacy policies, breach notification, business associate oversight, investigations, training, metrics, and coordination with legal, IT security, and audit. Supervise the Regulatory and Compliance Manager and support litigation/administrative privacy matters.
Summary Generated by Built In

KEY RESPONSIBILITIES

  • Operationalize healthcare regulatory guidance into actionable internal policies and procedures, draft, revise and maintain policies and procedures that reflect current regulatory requirements, operational realities and industry best practices.
  • Serve as a key compliance resource to teams across the organization, responding to compliance-related inquiries and providing clear, written actionable guidance on how to apply internal policies and regulatory requirements in day-to-day operations.
  • Support the development, implementation and monitoring of healthcare compliance education materials; conduct education sessions and help identify opportunities to reinforce policy adoption and awareness across teams.
  • Develop and administer the healthcare Compliance program through coordination with the Sr. Director, Compliance, internal stakeholders, and best practices.
  • Lead the development and execution of the Company’s healthcare compliance risk assessment and work plan, identifying key areas of risk and developing an annual audit plan. 
  • Conduct and support retrospective and prospective healthcare compliance audits and spot checks to identify potential gaps or areas of compliance vulnerability.  Collaborate with teams cross-functionally to develop appropriate action plans that address audit findings and introduce controls likely to prevent non-compliance performance.
  • Assist in collaborating with internal and external auditors during healthcare regulatory audit and monitoring activities.
  • Contribute to the preparation and execution of quarterly Compliance Committee meetings, including development of pre-read materials, tracking open issues, and surfacing risk themes or emerging compliance trends for leadership discussion.
  • Maintain professional and technical knowledge of healthcare compliance legal and regulatory requirements, including subject matter expertise in Medicare and state Medicaid program billing requirements, federal/state fraud, waste and abuse laws (e.g. Stark, EKRA, Anti-Kickback) and business relationship laws (Anti-Lobbying, FCRP, etc,).
  • Oversee and manage Baylor Genetics’ confidential and anonymous Hotline, to include proper routing of complaints, monitoring and ensuring timely completion of investigations and preparing metric reports for the Compliance Committee and other members of management.
  • Organize and manage administrative tasks involved in the oversight of key healthcare compliance risk areas.
  • Oversee and manage exclusion screenings to ensure compliance with regulations and contractual requirements.
  • Support compliance considerations in product and operational development, partnering with cross-functional teams to ensure new initiatives, workflows or rollouts align with internal policy expectations.
  • Perform other duties as assigned to support team and organizational objectives.
  • Comply with all company policies, procedures, and applicable regulatory requirements.

QUALIFICATIONS

Required

  • Bachelor's degree in Business Administration, Healthcare Administration, or a related field.
  • 10+ years relevant experience, with at least 5 years in the healthcare industry, preferably in a clinical laboratory environment.
  • 5+ years experience managing others, preferably in a healthcare compliance setting.
  • Adaptable and able to function independently, with little need for oversight, in a fast paced, highly fluid startup environment.
  • Ability to timely manage many high-risk, high-pressure projects/issues at once and prioritize effectively based on risk.
  • Strong communication skills with proven track record of success working with cross functional teams.
  • Working knowledge of applicable healthcare regulations and state and federal laws.
  • Working knowledge of third-party billing and coding standards for laboratory testing.
  • Computer skills and high competence with MS Office (Word, Excel, PowerPoint) and ability to easily adapt to third-party software solutions.
  • Equivalent combination of education and experience may be considered.

Preferred:

  • Active compliance certification; CHC, CCEP preferred.

COMPETENCIES

  • Ability to evaluate complex legal concepts and apply them to the Organization’s business practices.
  • Ability to prioritize projects and assigned work to meet changing deadlines.
  • Attention to detail to deliver error-free and quality product.

WORK ENVIRONMENT

  • Location: Hybrid / Remote
  • Frequently required to sit
  • Frequently required to stand
  • Frequently required to utilize hand and finger dexterity
  • Frequently required to talk or hear
  • Travel Requirements – minimal (<20%)

EEO STATEMENT

Baylor Genetics is proud to be an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome and encourage applicants from all backgrounds to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, pregnancy, childbirth, or any other status protected by applicable federal, state, or local law. If you need an accommodation during the application process, please contact our Human Resources team.

Qualifications Skills Preferred Leadership & Collaboration Expert Education Preferred Bachelors or better. Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Skills Required

  • Bachelor's degree in Business Administration, Healthcare Administration, Science, or related field
  • Graduate-level degree (MPH, MHA, MBA, JD) or equivalent
  • Seven years of healthcare compliance-related experience with at least five years of general privacy experience
  • Knowledge and experience ensuring compliance with HIPAA, federal and state privacy regulations
  • Preferred certification in Healthcare Compliance (CHC) or Healthcare Policy Compliance (CHPC)
  • Experience managing privacy programs, breach notification, investigations, and business associate agreements
  • Experience collaborating with IT Security/Information Services to integrate privacy and security programs
  • Familiarity with GDPR, FERPA, PCI and other privacy/regulatory frameworks
  • Supervisory experience (managing regulatory/compliance staff)
  • Deep technical expertise in NGS methods and assay development experience
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The Company
HQ: Houston, TX
202 Employees
Year Founded: 1978

What We Do

Baylor Genetics is a joint venture of H.U. Group Holdings, Inc. and Baylor College of Medicine, including the #1 NIH-funded Department of Molecular and Human Genetics. Located in Houston’s Texas Medical Center, Baylor Genetics serves clients in 50 states and 16 countries.

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