The Compliance Manager will support the Compliance Counsel to ensure implementation of appropriate policies and procedures, support compliance training, conduct investigations and maintain a system of reporting and ensure the integrity of all compliance investigations. This role will help ensure the Compliance Program effectively promotes prevention, detection, and resolution of instances of improper conduct to ensure conformity to state or federal laws, regulatory requirements, and the standards of conduct. This role will also be responsible for following up on reported incidents of non-compliance, conducting and/or coordinating internal investigations and preparing reports on the incidents and investigation findings.
• Reports to the Compliance Counsel in the Ethics & Compliance group
• Assist the Compliance Counsel and internal investigations team with assessing incoming violations relating to sales, advertising, marketing and promotional activities; conducting interviews; gathering evidence; providing summary reports; participating in key meetings; and assisting with coordination of risk assessment and providing triage on investigation matters.
• Support the development and implementation of programs to ensure compliance with federal and state laws governing the pharmaceuticals and medical device businesses, including, but not limited to, the Anti-Kickback laws, HIPAA, the FCA, the PDMA, the FDCA, FDAAA, the FCPA, and the federal Sunshine Act.
• Support the Compliance Counsel through interactions with business partners such as Marketing, Sales Operations, Medical Affairs, and Sales leadership.
• Provide support for field monitoring activities such as compliance ride alongs, speaker program monitoring, record reviews of call notes and emails, and other activities.
• Assist with creation and revision of policies and procedures supporting the elements of an effective compliance program
• Develop and deliver training or other methods to ensure all colleagues are educated regarding current developments in compliance including developing tools for use by internal customers.
• Bachelor’s degree required, J.D. degree strongly preferred
• 3+ years of experience in compliance in pharmaceutical industry (medical device experience is preferable as well)
• Knowledge of how pharmaceutical commercial operations function, and how compliance programs are effectively developed, communicated and managed.
• Knowledge of applicable laws and regulations, industry guidelines and best practices in compliance programs, including anti-kickback statutes, False Claims Acts, Patient Protection and Affordable Care Act (PPACA), state reporting statutes, and other laws. Strong business, legal and/or regulatory knowledge
• Experience in handling confidential and sensitive situations or information with ability to exercise a high degree of judgment and discretion.
• Must be able to exercise appropriate judgment, as necessary.
• Requires a high level of initiative and independence.
• Excellent written and oral communication skills
• Highly proficient in Microsoft Office
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 maental 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.
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.