Compliance Program Manager, Senior

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 other related experience in the healthcare and research fields.

- CHC, CRC or other recognized compliance certification required (or ability to obtain within first year of employment).

PREFERRED QUALIFICATIONS:

- JD or LLB from an accredited US law school preferred

- Advanced knowledge of federal and state research and healthcare regulations including US export control, research security, international collaborations and related regulations and policies including but not limited to the BIS 50% Rule; BioSecure Act; Foreign Investment Review; COINS Act; GDPR; NIST CUI; DOE Conflict of Interest; DOJ Data Security; ITAR & OFAC; NSF Research Security Policy & NSPM-33; Uniform Guidance; FARS; HIPAA; USG Policy – High Risk Life Sciences Research; DOD/W Section 1286 & 1260H

- Highest degree of credibility, integrity and discretion

- Demonstrated proficiency in project management methods and tools

- Demonstrated ability to work independently

- Excellent written and verbal communication skills, including ability to present findings and recommendations as required

- Microsoft Office product knowledge including Word, Excel and PowerPoint

- Effective supervisory skills, including the ability to coach and mentor others

- Sound decision making ability, considering all information and utilizing a big picture approach

- Ability to collaborate with others to seek resolutions of problems

- Ability to gather information from multiple sources to gain a thorough understanding of problems

- Mastery of technical skills to manage integrity and compliance operations, such as ability to deploy and use compliance-related software and develop compliance metrics and reporting

- Ability to effectively multitask in an unpredictable environment

- Ability to innovate, develop or adopt best practices and manage change

- Ability to think strategically about organizational risks and continuously document, improve, and streamline processes to advance the applicable compliance programs and initiatives assigned

The annual base salary range for this position is from $136,677 to $215,987, and pay offered will be based on experience and qualifications. This position may be eligible for relocation assistance. Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).

## Additional Information
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at [email protected] or by calling 206-667-4700.