Employee will be responsible for consistently delivering outcomes with cross functional impact. Employee will be expected to leads and/or significantly influence teams and/or projects with cross functional participants.
The employee will:
• Be responsible for live monitoring with significant travel.
• Monitor activities and processes in order to assess compliance with company policies and procedures.
• Directly manage at least one 3rd party consultant, if applicable, in their performance of Live Monitoring of Promotional Speaker Programs as part of the annual monitoring program.
• Assist the Sr. Director – Healthcare Law Auditing and Monitoring with implementation of a monitoring program that helps to ensure compliance with healthcare laws, regulations and guidance (such as the Anti-Kickback Statute, False Claims Act, OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code, AdvaMed Code, FDCA and PDMA) and helps to detect and prevent fraud.
• Performs live monitoring of both promotional and non-promotional field based personnel’s interactions with HCPs and HCI’s to ensure that the company’s compliance program is effective and the company satisfies its legal and regulatory obligations and other requirements and/or gudances.
• Maintain monitoring metrics and applicable reports for use in updates to the Chief Compliance Officer, and other leaders within the organization.
• Identifies and escalates potential compliance risks and weaknesses.
• Assists in developing processes and procedures that promote compliance with healthcare laws, regulations and guidance.
• Works with inter-company/cross-functional groups to help facilitate the live monitoring activities.
• Provides feedback on reports and documents intended for submission to various organizational committees, including the Board of Directors and Audit Committee of the Board Maintains a working knowledge of relevant trends, laws and regulations pertaining to healthcare law and regulatory compliance.
• Assists with monitoring activities related to communications by field employees, such as email, call note and field coaching report monitoring.
• Performs any other duties as identified by the members of the Compliance Committee or Management.
• Bachelors Degree + 10–15 years of experience in a regulated industry
• 5 – 7 years of experience within the pharmaceutical industry performing monitoring activities, i.e., live monitoring/ride alongs
• Experience with regulators, external auditors, independent review organizations
• PMP, HCCA or CFE +8 years of experience in a regulated industry
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
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.