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Corporate - General Attorney in Bothell, WA

Seattle Genetics Inc. Jan 09,2020 May 24,2019 Location USA Bothell WA
This job is expired...

In-House

Attorney

Corporate - General

3-7 yrs required

Profile

Manager, North America Auditing and Monitoring Responsibilities: Assess and monitor business activities for compliance with policies and standards as well as potential areas of risk through a combination of live and desk reviews. Support Director in development and administration of Risk Assessment and Management Plan (RAMP) policies and processes. Implement enhancements of 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 requirements. Execute process of assessing, monitoring and mitigating compliance risks across commercial and non-commercial functions by executing the compliance audit and monitoring programs, including the conduction of field rides and other live monitoring activities, with potential coordination and management of external resources as warranted and in collaboration with other assurance functions and functional points of contact. Performing detailed transactional audits, potentially including: engagement of assorted third-parties; research and educational grant funding; and other non-promotional practices. Document and summarize 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. Identify, develop and help implement enhanced monitoring controls as warranted. 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-based manner and help drive resolution within and beyond scope of responsibility. Identify matters that require elevation to senior management on mitigation of risk and improving the effectiveness of the Compliance Program.

Qualification and Experience

Qualifications: 3-5 years of experience with PhD or JD Degree, 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 is required. Prior auditing or monitoring experience is required. Experience in Healthcare Compliance, particularly in pharma/biotech strongly preferred. Strong knowledge of pharma/biotech and the various laws, regulations, and industry guidance that effect a compliance program is essential. This includes OIG and PhRMA guidelines, healthcare standard operating procedures, Sunshine provisions of the Affordable Care Act, Food, Drug & Cosmetics Act and supporting regulations, OPDP requirements and state price reporting statutes. Effective team collaboration skills across functions. Experience with data analytics and data mining skills, including use of current analytical/BI tools for data analysis (Tableau, QlikView, Qlik Sense, etc.), is desirable. Strong project management and time management skills, including the ability to manage multiple projects concurrently. High level problem solving, judgment, detail-oriented and confidentiality; 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.

Company info