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Years of Experience
Date Last Verified
ProfileSenior Manager, Compliance (R&D) Duties: Provide direct oversight for moderate to complex elements of compliance program at the therapeutic area, business unit, functional or corporate level. Partners with all levels of business functions (including Global RD, HEOR, and Global Medical Affairs) to provide moderate to complex OEC and functional policy interpretation and provide guidance on the requirements. Primary areas of focus include: Clinical Development/Research, Global Medical initiatives and programs, HEOR initiatives, including Real-World Evidence. Provides guidance on proposed business strategies and programs, identifies moderate to complex legal and regulatory issues, analyzes alternatives and works with legal and other functions, as appropriate, to propose solutions to the business. Develops model and conducts compliance risk assessments, trend analysis and provides recommendations for compliant business activities. Provides strategic insight to development of KPIs/metrics relating to relevant compliance areas. Conducts moderate to complex policy and procedure reviews and updates related to OEC policy and functional procedures ensuring clarity, applicability and compliance. Develops, delivers and updates OEC’ s comprehensive training program on moderate to complex OEC and functional policies and procedures. Develops, implements, modifies, and oversees corporate and/or functional monitoring plans and any corrective actions to ensure compliance with policies and procedures. Assists ECO on compliance audits, when necessary, such as overseeing the fulfillment of auditors’ requests and acting as a liaison between the business and auditors during on site activities. Expected to evaluate and help respond to moderate to complex preliminary audit findings and recommendations, and to guide the business in preparing corrective action(s) to address moderate to complex findings and recommendations, and work with the business to ensure timely completion. Participates in and may lead moderate to complex cross-functional OEC programs.
Qualification and Experience
Qualifications: BA/BS required. CPA, Master's, JD, or equivalent work experience preferred. 7+ years' experience with, or exposure to, business functions such as compliance, legal, regulatory affairs, government affairs, and finance. Preferred: experience providing compliance support in pharma/biopharma or medical device industry.
1 N Waukegan Rd
North Chicago, IL 60064