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Clinical Development Compliance Manager 
(Job)

adzuna-us  |  United States  |  

Ref:
ADZUNA-US-E4TR1
Direct:
Employer:
Location:
United StatesUS
Category:
Other/Other
Work Type:
Permanent
Work Time:
Full Time
Tags:
job,united-states,adzuna

Description 

The Compliance Manager will be responsible for routine to moderately complex elements of AbbVie's compliance program related to Research & Development.

Key Responsibilities include: Partners with all levels of key business functions to provide routine to moderately complex OEC and functional policy interpretation and provide guidance on the requirements.

Conducts compliance risk assessments, trend analyses and provides recommendations for compliant and best practice business activities.

Conducts routine to moderately 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 routine to moderately complex OEC and functional policies and procedures, including the Operating Procedures for Program Funding and AbbVie's Code of Business Conduct, as well as the current compliance environment.

Possesses working knowledge of AbbVie's business, the current compliance environment and the broader business impact.

Participates in and may lead cross-functional OEC projects.

Provides guidance on proposed business strategies and programs, identifies routine to moderately complex legal and regulatory issues, analyzes alternatives and works with legal and other functions, as appropriate, to propose solutions to the business.

Develops, implements, modifies, and oversees corporate and/or functional monitoring plans and any corrective actions to ensure compliance with policies and procedures.

Assists OEC Associate Director 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 routine to moderately complex findings and recommendations, and work with the business to ensure timely completion.

Bachelor's Degree required.

CPA, Master's, JD, or equivalent work experience preferred.

Experience in clinical development including areas of Fair Market Value (FMV)/payments, clinical compliance, contracting, clinical trials/protocols and GCP preferred.

Minimum of 4 years experience with, or exposure to, business functions such as clinical compliance, legal, regulatory affairs, government affairs, and finance.

Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.

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