Manager Compliance Monitoring & Auditing
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
The Manager, Compliance Monitoring & Auditing will report to the Assoc. Director Monitoring, Analytics & Transparency and be part of the team responsible for executing Seagen’s healthcare compliance monitoring and auditing program.
Duties include conducting live monitoring and transactional reviews, business process audits, and control and risk mitigation plan assessments. In addition, role involves coordinating resources to conduct audits of compliance with U.S. federal and state laws and regulations related to the promotion, sale and marketing of Seagen therapies.
- Monitor Seagen business activities for compliance with Seagen policies and standards as well as assess potential areas of risk through a combination of live/in-person and desktop/transactional reviews as well as analyzing and interpreting data to identify potential risk areas to monitor based on data anomalies or exceptions
- Support Director in development and administration of Seagen’s Risk Assessment and Management Plan (RAMP) policies and processes
- Implement enhancements of Seagen’s risk-based monitoring program policy and processes designed to help ensure compliance with healthcare laws, regulations and guidance (such as the Anti-Kickback Statute, False Claims Act, OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code & FDCA), and detect and prevent potential fraud and non-compliance, and any other related Seagen requirements
- Performing detailed transactional reviews/audits, potentially including engagement of assorted third parties; research and educational grant funding; and other non-promotional practices
- Document, summarize and communicate monitoring and auditing results and findings, including recommendations for corrective action or enhanced risk mitigation
- Effective use of systems and tools related to RAMP, monitoring, and analytics, and identifying potential enhancements to the same for improvements in effectiveness and efficiency
- Be able to handle all matters as confidential, demonstrate an ability to effectively and continually prioritize, and identify new issues requiring attention in a risk-prioritized manner and help drive resolution within and beyond scope of responsibility
- Working hybrid/remotely from a Western US location required
- Travel up to 40%
- 3-5 years of experience with PhD or JD., 5-7 years of experience with a Master’s degree, and 8-10 years of experience with a Bachelor’s degree
- Experience with a global or regional life sciences company, accounting firm, legal firm, or healthcare consulting firm with emphasis in life sciences
- Prior auditing and/or monitoring experience
- Strong knowledge of pharma/biotech and the various laws, regulations, and industry guidance that affect a compliance program is essential. This includes OIG and PhRMA guidelines, healthcare standard operating procedures, Sunshine provisions of the Affordable Care Act (aka Sunshine Act / CMS Open Payments), Food, Drug & Cosmetics Act and supporting regulations, OPDP requirements
- Experience in Healthcare Compliance, particularly in pharma/biotech strongly preferred
- Effective team collaboration skills across functions
- Experience accessing common systems of records (e.g., Oracle/SAP ERP, Concur, Veeva/Salesforce, etc.)
- High data literacy and experience with data analytics, including use of current analytical/BI tools for data analysis (Excel, SQL, PowerBI, Tableau, QlikView, Qlik Sense, etc.), is highly desirable
- Strong project management and time management skills, including the ability to manage multiple projects concurrently and independently
- High level problem solving, judgment, detail-oriented and appropriate judgement on confidential matters; comfortable with ambiguity and can adapt style and tactics based on situation
- Strong interpersonal skills, with ability to forge collaborative relationships with all levels and functions of the organization
- Ability to effectively prepare and present analytical written and oral communications appropriate for multiple audiences
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.