Healthcare Compliance Specialist
SOPHiA GENETICS, United States

Ranked among the "50 Smartest Companies" in the world according to the MIT Technology Review, SOPHiA GENETICS is a fast-paced, high-growth health-tech company. Combining deep expertise in life sciences, medical disciplines and mathematical modelling, we bring to market data analytics solutions to support healthcare professionals in better diagnosing and treating patients. Today SOPHiA’s products and services are trusted by over 1,000 leading hospitals and laboratories worldwide, connected to each other and motivated by the goal of providing better outcomes to all patients.

As we further our mission to democratize data-driven medicine worldwide, we are looking for a Healthcare Compliance Specialist to join our growing Compliance team. It is a rare opportunity to shape the future of a company that is young, successful, international, and on a world-changing mission.

Based at our US headquarters in Boston, MA, you will manage our US healthcare compliance program and will assist the group Compliance Manager with the implementation of group wide compliance initiatives, perform compliance risk assessments and support the development of internal control framework and assist in the development of trainings.

This role requires experience in the compliance function of a life sciences or healthcare organization.

If you have the skills, the experience and the passion, we would love to hear from you.

Key Responsibilities and deliverables

As our Healthcare Compliance Specialist you will:

• Support management and implementation of compliance programs (especially Sunshine Act, False Claims Act, HIPAA, anti-bribery and corruption (FCPA), transparency reporting, anti-kickback statute, etc.).
• Advise the company on legal impacts of CAP/CLIA regulations as well as FDA guidance.
• Develop, implement and administer compliance policies, procedures, and practices.
• Review promotional documentation to ensure their compliance with applicable regulation.

Proactively identify, evaluate and manage compliance risks and provide pragmatic options for risk mitigation and management, in accordance with our internal control framework and policies

Provide compliance advice, implement training and communication for the Code of Conduct; other relevant policies, procedures, and standards

• Perform HIPAA Risk Assessment, update HIPAA policies and procedures

Requirements

Knowledge, Skills and Experience Required

• 5+ years of compliance experience in a life sciences/healthcare practice in a Big4 or law firm, or in a Compliance function of a Life Sciences or healthcare organization (pharma, medical devices, biotech)
• Juris Doctor, MBA, or MS degree.

Solid understanding of industry standards for ethics and compliance risk within the Life Sciences/Healthcare industry

• Knowledge of life science processes, controls, and regulatory requirements in core areas

Preferred:

• CHC or CHPC certification desired.
• CIA, CFE, Risk Management and/or Compliance certificate desired.
• Member of the Bar in a U.S. jurisdiction preferred.
• Demonstrated experience in reviewing, designing and implementing governance, risk and compliance frameworks.
• Must have strong verbal and written communication skills, with the ability to make the complex simple.

Must be a team player and have strong planning and organizational skills.

• Fluent in English. Any other language an asset

Benefits

• A flexible, friendly, and international working environment with a collaborative atmosphere
• An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illnesses.
• A fast-growing company with plenty of opportunity for personal growth and development
• A hard technical challenge to solve with exciting modern technology - cloud computing, Big Data, DevOps, machine learning

Location: Home Office or Boston

Start: ASAP (or as agreed)

Contract type: Permanent full-time

Application process

If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.

After an initial screening process, candidates will be invited for remote interviews. Selected candidates will then be invited for personal interviews.

Job Rewards and Benefits