Associate Compliance Counsel (Hybrid)
Avanir Pharmaceuticals
Job Summary
Associate Compliance Counsel is a key liaison between Ethics & Compliance (E&C) and Otsuka’s business and operational teams. Associate Compliance Counsel provides corporate compliance risk mitigation guidance, serving as a trusted advisor to business team leaders and subject matter experts.
Job Description
- Reports to the Associate Compliance Officer-Senior Director or Compliance Counsel-Director in the Ethics & Compliance Department.
- Builds partnerships with commercial business and operational stakeholders as well as other enabling functions to identify and assess the regulatory risks associated with brand and corporate initiatives and align on mitigation strategies.
- Supports systems and operations that operationalize commercial tactics
- Monitors federal and state legislation, guidance, and enforcement activity to inform risk evaluations and business recommendations.
- Collaborates cross-functionally within Ethics & Compliance to support the development of training, monitoring, and remediation tactics.
- Creates and updates written policies, guidance, and training to support an effective compliance program, reinforce adherence with industry codes, and foster a culture of integrity.
- Supports compliance with state laws including drug price transparency and representative licensure and disclosure.
- Develops and presents compliance training to field-based colleagues. Develops and delivers new training content or other methods to ensure all colleagues are educated regarding current developments in compliance, including developing tools for use by the Ethics & Compliance Department.
- Supports field monitoring and record auditing activities as needed.
- Provides additional support to the Ethics & Compliance team as needed.
Qualifications
Required
- Juris Doctorate degree
- Bar admission and licensure in good standing in at least one U.S. jurisdiction
- At least 3 years of substantive legal and/or compliance experience in the life sciences industry, in-house at a pharmaceutical or medical device company and/or at a firm counseling life sciences clients.
- In-depth understanding of the laws, regulations, and codes/guidance governing the US healthcare industry as well recent enforcement actions and policy initiatives.
- Demonstrated achievement operationalizing compliance with laws, guidance, and industry codes; identifying and mitigating business risk; educating business stakeholders and achieving compliant solutions to business problems; collaborating with other enabling functions (Legal, Promotion Compliance/Regulatory, etc.) and fostering an organizational culture of integrity.
- Strong interpersonal, analytical, writing, communication, organizational, project management and presentation skills.
- Experience in handling confidential and sensitive situations or information with an ability to exercise a high degree of judgment and discretion.
- Up to 10% travel based on business needs.
Preferred
- Experience counseling on field promotional tactics; cross-functional initiatives involving brand promotional, medical, disease education and patient support initiatives; and launch preparedness activities.
- Experience representing Legal or Compliance on multi-disciplinary committees (promotion compliance review, target review, etc.).
- Experience directly counseling brand, market access, and/or patient support teams.
#LI-Hybrid
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
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