Senior Director E&C Healthcare Law Monitoring and Auditing develops and oversees the comprehensive monitoring and auditing program, with a primary focus on all aspects of healthcare law including but not limited to: Sales, Marketing, Medical Affairs, Market Access, Patient Support, and Patient Advocacy. Oversees the performance of all live monitoring and operational controls and transactions reviews of activities, systems and procedures for products and processes; the preparation of monitoring and operational control/transaction review plans and reports, and management of monitoring and review follow-up activities to ensure timely resolution and completion of corrective actions.
Please note that this position can be located in either Princeton, NJ or Rockville, MD
* Oversees the implementation of a comprehensive monitoring and auditing program as part of Otsuka's comprehensive compliance program, focuses on all aspects of healthcare law including but not limited to: Sales, Marketing, Medical Affairs, Market Access, Patient Support, and Patient Advocacy.
* Works with applicable E&C Compliance Counsel to prepare product risk assessment on an annual basis and updates as necessary.
* Works with CCO to prepare and regularly update Enterprise Compliance Risk Assessment parameters to ensure they align with internal and industry risk areas.
* Provides reports to leadership teams (Compliance Committee; Board of Directors, Audit Committee of the Board) on risk areas and results of monitoring and auditing activities.
* As needed assists in the review, editing and development of technical documents, such as toolkits, and operational procedures SOPs, data summaries, transactional review reports, investigations, memos, etc.
* Liaises with other departments (e.g. IT) and external vendors enhance existing solutions and develop new solutions to enhance the monitoring and auditing processes.
* Collaborates with internal stakeholders to ensure successful implementation.
* BS/BA degree
* Minimum 15 years experience in corporate compliance or auditing related field Pharmaceutical, Healthcare or related industry experience
* Excellent interpersonal, communication skills and ability to work in cross-functional teams
* Strong understanding of the foundational requirements needed to build and ensure a culture of integrity
* Good understanding of the complexities of managing external service providers
* Awareness of new developments and trends in the industry
* Solid management skills and the ability to gain the respect of others in the organization
* Strong issue spotting, problem solving and project management skills
* Experience in managing contract service providers
* Ability to accomplish objectives through influence in a matrix organization
* Strong computer skills with Word, Excel, PowerPoint, and Outlook
* Up to 10% travel based upon business needs
* CPA or CFE certification
* MS, MBA or JD + 10 years experience in corporate compliance or auditing related field
The HBA's purpose is to further the advancement and impact of women in the business of healthcare
373 Route 46 West Bldg E, Suite 215 Fairfield, NJ 07004
Phone: +1 (973) 575-0606 Fax: +1 (703)-852-4414 Email: email@example.com