Compliance Program Manager, Senior

Fred Hutch Cancer Center; Seattle (WA); Remote; USD 120,000 - 160,000; Full time

Job summary

Fred Hutchinson Cancer Center is seeking a Senior Compliance Program Manager to lead enterprise-wide compliance initiatives including export controls and research security. The role collaborates with Enterprise Risk Management, Internal Audit, Business Development, HR, Office of the General Counsel and Clinical Research Support to ensure adherence to laws and policies.

Remote work is offered. Qualified candidates will have a master’s degree in a related field and at least five years of

Qualifications

• MINIMUM QUALIFICATIONS: Master's degree in a business or healthcare-related field or equivalency.
• Minimum 5 years of experience in data analytics, healthcare compliance, research compliance, auditing or related fields.

Responsibilities

• Primary responsibility for day-to-day operation and management of export control, foreign influence, research misconduct and other compliance program areas as assigned by the VP CCO.
• Exercise independent judgment in selecting methods and evaluation criteria to achieve results and secure necessary approvals, authorizations, and licenses.
• Review third party arrangements involving international entities and foreign nationals regarding national security risks in health care and research.
• Research and analyze export control regulations and related topics and provide training and guidance to faculty and staff.
• Conduct export control reviews, including classifications, shipping reviews, and international travel assessments.
• Support efforts to counter improper foreign influence, including risk assessments and training.

Skills

Data analytics

Healthcare compliance

Auditing

Regulatory compliance

Education

Master's degree in business or healthcare-related field

Job description

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

Reporting to the Vice President and Chief Compliance Officer (VP CCO) and in collaboration with the compliance program directors and managers, the Senior Compliance Program Manager (SCPM) works closely with key Fred Hutch stakeholders including Enterprise Risk Management, Internal Audit, Business Development, Human Resources, Office of the General Counsel, Clinical Research Support, Information Security and others across the enterprise to ensure compliance with applicable laws, regulations and Fred Hutch policies. The SCPM is responsible for leading the development, implementation and maintenance of various enterprise international compliance initiatives including but not limited to export controls, research security, international third-party risk, foreign influence, research misconduct, conflicts of interest and other key compliance initiatives as assigned by the VP CCO in accordance with state, and federal guidelines, laws and consistent with industry best practices.

Postiion can be offered fully remote:

Responsibilities

• Primary point of contact for day-to-day operation and management of the export control, foreign influence, research misconduct and other compliance program areas as assigned by the VP CCO for the oversight, monitoring of compliance with all applicable laws, regulations, policies and procedures.
• Exercises independent judgment in selecting methods, techniques and evaluation criteria for obtaining results independently securing necessary approvals, authorizations, and licenses to facilitate the export control program.
• Internal and external contacts often pertain to organization plans and
• Acts as the subject matter expert and supports the Fred Hutch community by researching and analyzing export control regulations, improper foreign influence regulations, and other international compliance topics and provides training, education and guidance to faculty, and staff.
• Reviews third party arrangements involving international entities and foreign nationals regarding national security risks related to health care, research and other related activities of Fred Hutch.
• Conducts export control reviews, including classifications, shipping reviews, and international travel assessments and assist in applying for export licenses or using exemptions and implementing technology control plans, as needed.
• Supports Fred Hutch's efforts to counter improper foreign influence, including conducting risk assessments, providing training and educational outreach.
• Performs enterprise and department-specific risk assessments, develops and maintains policies and procedures, and assists departments in establishing monitoring mechanisms.
• Builds close working partnerships with key team members to effectively execute program priorities and, as appropriate, coordinate program initiatives with member institutions.
• Monitors and maintains legal and regulatory activity regarding applicable local, state, federal and international laws, rules, and regulations including notices and other updates from applicable government oversight agencies. Assists programmatic compliance directors with statutory interpretation and formulates strategy to meet those requirements.
• In consultation with the conflicts of interest program Director, provides regulatory and compliance guidance on matters including but not limited to institutional, research and board conflicts of interest.
• Other duties as assigned.

Qualifications

• MINIMUM QUALIFICATIONS:
• Master's degree in a business or healthcare-related field or equivalency.
• Minimum 5 years of experience in data analytics, healthcare compliance, research compliance, auditing or o