Sr. Director US Compliance Program Implementation

Sr. Director US Compliance Program Implementation

Description of Sr. Director US Compliance Program Implementation:

Responsibilities
 
Description:

The Sr. Director, US Compliance Program Implementation is accountable to the US Compliance Officer to lead the US Compliance Program Implementation team, assuring the development and management of the infrastructure supporting the US Compliance Program. The Sr. Director is responsible for operation and continuous improvement of the policy, training, Helpline, investigations and specialized monitoring elements of the US Compliance Program, and for ensuring that appropriate technology and processes are in place to meet various requirements, including provision of regular reports to the Global Compliance Officer, the Business Integrity and Assurance Team and other members of senior US and global leadership.

Major Responsibilities :

• Provide cross-functional leadership to assist in the implementation of the US Compliance Program in all respects
• Identify and prioritize areas of compliance risk within the US Business
• Direct and support the review and causation analysis necessary to identify, correct and prevent compliance-related issues within the US Business
• Ensure close collaboration with Group Internal Audit to support the conduct of formal audits to assess the effectiveness of the US Compliance Program
• Lead the creation of objectives and strategic plans for, and manage the performance of, the US Compliance Program Implementation team
• Direct efforts of Compliance Policy Sr. Manager to ensure continuous improvement of US Business policies, standards, procedures and guidelines
• Provide cross-functional leadership for US policy formulation, amendment and review as leader of the Policy Review Board
• Coordinate US input for global policies, standards, procedures and guidelines
• Lead policy harmonization for external collaborations and AZ acquisitions
• Act as US Nominated Signatory to ensure compliance with US policies for global engagement of US Healthcare Providers
• Direct efforts of Sr. Manager, Compliance Training & Communications in creation and execution of the annual US Compliance training plan and an annual communications plan in support of AZ USBC compliance initiatives
• Provide cross-functional project team leadership within USBC for corporate compliance training and communication
• Facilitate inclusion of global counterparts in US Business policy training pertaining to activities with US Healthcare Providers
• Direct efforts for creation and maintenance of web-based compliance training repository
• Maintain appropriate tracking and reporting mechanisms for certifications of training and education for all employees
• Direct efforts of Compliance Investigations Sr. Managers to assure that all obligations relating to compliance investigations and violations are met
• Provide oversight for technology and operation of Code of Conduct Helpline and investigations database
• Direct efforts of Director, Monitoring & Samples Compliance to ensure compliance of US Business activities relating to sampling and patient assistance programs
• Manage budgets for training vendors, systems development and other relevant outsourced services
• Support US Compliance Officer in operation of Continuous Assurance and other quarterly or annual business review processes

   

Sr. Director US Compliance Program Implementation

Requirements of Sr. Director US Compliance Program Implementation

Qualifications :

• 8 years pharmaceutical experience
• Demonstrated experience with respect to development of policies, training and communications and conduct of investigations
• Extensive knowledge of US and international regulations related to sales, marketing and medical/scientific activities
• In-depth knowledge of guidelines governing appropriate interactions with healthcare providers and decision makers (OIG, PhRMA, AMA, FDA, etc.)
• Excellent strategic, organizational, communication, influencing and interpersonal skills
• Strong analytic, problem solving and project management skills
• Extensive experience working on cross-functional teams Preferred Background
• 5 years legal practice or experience in compliance-related role
• Proven people management skills

Keywords : pharmaceutical, computer, computers,development sales, marketing and medical/scientific, management