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.
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
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.