Medical Compliance Manager

Seattle, WA

ABOUT US:

The Washington Center for Bleeding Disorders (WACBD) is a non-profit organization dedicated to providing comprehensive care and support for individuals with bleeding disorders. As a hemophilia treatment center, we receive some HRSA funding, operate a 340B pharmacy, and conduct clinical research to advance treatment and care.

 

POSITION SUMMARY:

The Compliance Manager will be responsible for ensuring that WACBD adheres to all applicable federal, state, and local regulations, as well as internal policies and procedures. This role involves overseeing compliance throughout the organization, conducting audits, and providing training to staff to maintain the highest standards of ethical and legal conduct. This role also serves as the Privacy Officer to oversee the protection of patient health information (PHI) and other sensitive data and will be responsible for managing all activities related to the development, implementation, and maintenance of WACBD’s privacy policies and procedures. This role ensures compliance with federal and state privacy laws, including HIPAA, and protects the confidentiality of patient information.

 

KEY RESPONSIBILITIES:

  • Develop, implement, and maintain compliance and privacy policies to ensure adherence to HIPPA, HRSA, 340B, and other relevant regulations.
  • Proactively conduct regular audits and risk assessments to identify potential compliance and/or privacy issues and implement corrective actions. This includes:
  • Monitor changes in laws and regulations that may affect the organization and update policies and procedures accordingly.
  • Provide training and education to staff on compliance/privacy-related topics, including HIPAA, 340B program requirements, and clinical research regulations.
  • Serve as primary point of contact for any compliance inquiry.
  • Investigate and resolve compliance/privacy issues and complaints, ensuring timely and effective resolution.
  • Serve as the primary point of contact for regulatory agencies and manage all compliance/privacy-related communications and reporting.
  • Work with auditors and external agencies to provide the necessary information that assures the completion of a successful audit.
  • Collaborate with other departments (pharmacy, clinical, research, billing/contracts, accounting, HR and IT) to ensure compliance with all regulatory requirements and internal policies.
  • Track/record any policy breach, and communicate to the Executive Team
  • Implement corrective actions to address identified compliance gaps
  • Prepare and present regular compliance/privacy reports to senior management and the board of directors.
  • Work with legal counsel as needed to conduct regulatory compliance reviews.
  • Other duties as assigned.
    • Proactively conduct regular compliance audits to ensure clinic operations adhere to policies and regulatory requirements.
    • Review department workflows and procedures for compliance and update accordingly.
    • Proactively and independently review new systems or processes to ensure compliance with regulatory agencies.

 

QUALIFICATIONS:

  • Bachelor's degree in healthcare administration, business, law, or a related field; advanced degree preferred.
  • Minimum of 5 years of experience in a compliance role within a healthcare organization.
  • In-depth knowledge of HRSA, 340B, HIPAA, CMS, and other relevant healthcare regulations.
  • Strong analytical and problem-solving skills, with the ability to conduct thorough investigations and risk assessments.
  • Excellent communication and interpersonal skills, with the ability to effectively train and educate staff.
  • Detail-oriented and highly organized, with the ability to manage multiple projects and deadlines.
  • Certification in healthcare compliance (CHC) or similar credential preferred.
  • Experience in interpreting and applying regulations, policies, and procedures for proper business operations.
  • Ability to interpret complex regulations and translate them into actionable policies
  • Excellent organizational and analytical skills, experience with problem-solving under pressure and the ability to meet deadlines.
  • Demonstrated leadership and project management experience

 

PROFESSIONAL EXPECTATIONS:

  • Conduct oneself in a professional manner, exhibiting the highest regard for patients and fellow employees.
  • Understand role and responsibilities.
  • Comply with all organizational policies and procedures.
  • Continuously seek professional development and keep abreast of hemophilia and bleeding disorder breakthroughs and news.
  • Cultivate diversity and respect.

 

 

I, _________________________, acknowledge I have read the above job description for the Compliance Coordinator/Privacy Officer and understand my responsibilities. I can perform the essential job functions as outlined with or without any reasonable accommodation.

 

 

Employee Signature:                                                                                                   Date:                                     _

 

 

Supervisor Signature:                                                                                                     Date:                                      _

 

JOB TITLE: Compliance Manager & Privacy Officer

REPORTS TO: Finance and Operations Director

PERCENT EFFORT: 1.0 FTE

STATUS: Full-time non-exempt

ABOUT US:

The Washington Center for Bleeding Disorders (WACBD) is a non-profit organization dedicated to providing comprehensive care and support for individuals with bleeding disorders. As a hemophilia treatment center, we receive some HRSA funding, operate a 340B pharmacy, and conduct clinical research to advance treatment and care.

 

POSITION SUMMARY:

The Compliance Manager will be responsible for ensuring that WACBD adheres to all applicable federal, state, and local regulations, as well as internal policies and procedures. This role involves overseeing compliance throughout the organization, conducting audits, and providing training to staff to maintain the highest standards of ethical and legal conduct. This role also serves as the Privacy Officer to oversee the protection of patient health information (PHI) and other sensitive data and will be responsible for managing all activities related to the development, implementation, and maintenance of WACBD’s privacy policies and procedures. This role ensures compliance with federal and state privacy laws, including HIPAA, and protects the confidentiality of patient information.

 

KEY RESPONSIBILITIES:

  • Develop, implement, and maintain compliance and privacy policies to ensure adherence to HIPPA, HRSA, 340B, and other relevant regulations.
  • Proactively conduct regular audits and risk assessments to identify potential compliance and/or privacy issues and implement corrective actions. This includes:
  • Monitor changes in laws and regulations that may affect the organization and update policies and procedures accordingly.
  • Provide training and education to staff on compliance/privacy-related topics, including HIPAA, 340B program requirements, and clinical research regulations.
  • Serve as primary point of contact for any compliance inquiry.
  • Investigate and resolve compliance/privacy issues and complaints, ensuring timely and effective resolution.
  • Serve as the primary point of contact for regulatory agencies and manage all compliance/privacy-related communications and reporting.
  • Work with auditors and external agencies to provide the necessary information that assures the completion of a successful audit.
  • Collaborate with other departments (pharmacy, clinical, research, billing/contracts, accounting, HR and IT) to ensure compliance with all regulatory requirements and internal policies.
  • Track/record any policy breach, and communicate to the Executive Team
  • Implement corrective actions to address identified compliance gaps
  • Prepare and present regular compliance/privacy reports to senior management and the board of directors.
  • Work with legal counsel as needed to conduct regulatory compliance reviews.
  • Other duties as assigned.
    • Proactively conduct regular compliance audits to ensure clinic operations adhere to policies and regulatory requirements.
    • Review department workflows and procedures for compliance and update accordingly.
    • Proactively and independently review new systems or processes to ensure compliance with regulatory agencies.

 

QUALIFICATIONS:

  • Bachelor's degree in healthcare administration, business, law, or a related field; advanced degree preferred.
  • Minimum of 5 years of experience in a compliance role within a healthcare organization.
  • In-depth knowledge of HRSA, 340B, HIPAA, CMS, and other relevant healthcare regulations.
  • Strong analytical and problem-solving skills, with the ability to conduct thorough investigations and risk assessments.
  • Excellent communication and interpersonal skills, with the ability to effectively train and educate staff.
  • Detail-oriented and highly organized, with the ability to manage multiple projects and deadlines.
  • Certification in healthcare compliance (CHC) or similar credential preferred.
  • Experience in interpreting and applying regulations, policies, and procedures for proper business operations.
  • Ability to interpret complex regulations and translate them into actionable policies
  • Excellent organizational and analytical skills, experience with problem-solving under pressure and the ability to meet deadlines.
  • Demonstrated leadership and project management experience

 

PROFESSIONAL EXPECTATIONS:

  • Conduct oneself in a professional manner, exhibiting the highest regard for patients and fellow employees.
  • Understand role and responsibilities.
  • Comply with all organizational policies and procedures.
  • Continuously seek professional development and keep abreast of hemophilia and bleeding disorder breakthroughs and news.
  • Cultivate diversity and respect.

 

 

I, _________________________, acknowledge I have read the above job description for the Compliance Coordinator/Privacy Officer and understand my responsibilities. I can perform the essential job functions as outlined with or without any reasonable accommodation.

 

 

Employee Signature:                                                                                                   Date:                                     _

 

 

Supervisor Signature:                                                                                                     Date:                                      _