AbbVie Senior Manager, R & D Compliance in Lake County, Illinois
The Sr. Manager, R & D Compliance, will provide direct oversight for moderate to complex elements of AbbVie’s compliance program at the therapeutic area, business unit, functional or corporate level.
Key Job Responsibilities:
- The Senior Manager will perform the following with minimal to moderate supervision from Ethics and Compliance Officer:
o 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
o Develops model and conducts compliance risk assessments, trend analysis and provides recommendations for compliant business activities.
o Provides strategic insight to development of KPIs/metrics relating to relevant compliance areas
o Conducts moderate to complex policy and procedure reviews and updates related to OEC policy and functional procedures ensuring clarity, applicability and compliance.
o Develops, delivers and updates OEC’ s comprehensive training program on moderate to complex OEC and functional policies and procedures,
o Develops, implements, modifies, and oversees corporate and/or functional monitoring plans and any corrective actions to ensure compliance with policies and procedures. Coordinates with business relating to IRO audits.
o 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. o 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.
- Possesses solid working knowledge of AbbVie’s business, the current compliance environment, and the broader business impact.
Participates in and may lead moderate to complex cross-functional OEC programs.
May have direct reports with people management responsibility.
Key Leadership Competencies:
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
- Learns, fast, grasps the 'essence' and can change the course quickly where indicated
- Raises the bar and is never satisfied with the status quo
BA/BS required. CPA, Master's, JD, or equivalent work experience preferred.
Minimum of 7 year's 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
Job Classification: Experienced
Primary Location: USA-Illinois-Lake County
Travel: Yes, 10 % of the Time
Req ID: 1701398
Equal Opportunity Employer Minorities/Women/Veterans/Disabled