Director, Ethics & Compliance Business Partner
Veloxis Pharmaceuticals, Inc.

Job Info

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The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:
Veloxis Pharmaceuticals, Inc.

Job Description:

This position contributes to the Company's success through supporting the Ethics and Compliance program in partnership with key business functions as defined below. The position is responsible for driving proactive and collaborative partnerships through consultation on applicable laws, regulations and guidance.

Summary of Key Responsibilities

•Provides compliance advisory services to Commercial (Sales, Marketing, Market Access) and Medical Affairs business units ("Business Units") in alignment with laws, regulations, the Company's Code of Conduct, polices/procedures, and the Company's Ethics and Compliance program. This includes:

--Anti-bribery/anti-corruption laws (e.g., Foreign Corrupt Practices Act (FCPA))

--Federal Food, Drug and Cosmetic Act (FD&C) and FDA regulations

--False Claims Act (FCA), Anti-Kickback Statute (AKS)

--Federal Sunshine Act and relevant state transparency/aggregate spend laws

--PhRMA Code on Interactions with Health Care Professionals (HCP) guidance

--OIG guidance relating to compliance programs and interactions with HCPs, and

--Other relevant federal and state laws governing compliance.

•Supports pull-through of Company's evolving global compliance program in accordance with the OIG 7 Elements of an Effective Compliance Program.

•Identifies new and emerging risks within the Business Units' business functions and responds with a risk posture calibrated to business needs and growth imperatives.

•Delivers meaningful and effective risk-based compliance training to the Business Units teams.

•Supports and pulls through the Ethics and Compliance Monitoring Program ("Monitoring Program")), including conducting field-based employee visits, attending live and virtual speaker programs, and other field-based interactions with HCPs as identified by the approved Monitoring Program.

•Supports best practices to evolve the compliance program goals, objectives, strategy, and structure inclusive of assisting in establishing metrics and monitoring processes to demonstrate effectiveness over an expanded mandate.

•Supports Compliance Operations in conducting investigations and corrective/preventative measures.

•Supports the Company's Ethics and Compliance Committee on a regular basis in collaboration with the Company's Chief Ethics & Compliance Officer and the Ethics and Compliance team.

•Supports the Company's' privacy program across the Business Units' business functions in partnership with the Company's Legal department.

•Supports periodic internal reviews, risk assessments, monitoring, and auditing in partnership with business functions to ensure that Ethics and Compliance identifies potential compliance risks and remediates where necessary.

Required Qualifications and Skills

• BA/BS. MA/MS a plus.
• Minimum of 4 years of relevant compliance experience in pharmaceuticals/biotech, preferably 6 years of compliance experience in a healthcare setting. Some prior experience in pharmaceutical sales and/or marketing, desirable.
• Experience in compliance program strategy and transformational initiatives between business units and corporate risk and compliance functions, preferred.
• Ability to recognize compliance risk and develop workable strategies to mitigate such risk.
• In-depth knowledge of U.S. laws, regulations, and codes relevant to job responsibilities.
• Ability to collaborate with business partners, influence peers, and interact with both senior management and field-based team members.
• Ability to build and maintain solid, collaborative working relationships across multiple functions and levels of management; and drive improvement initiatives with a sense of urgency.
• Ability to work in a fast-paced, dynamic organization, supporting a rapidly growing business.
• Exceptional relationship-building skills; must be a team player and support the Ethics and Compliance function's goal of proactive and collaborate relationships with all business functions.
• Strong presentation, verbal, and written skills.
• Strong computer skills with literacy in new media, and experience integrating information and data from multiple applications. Advanced proficiency in MS Office Suite and any presentation tools.

Travel Requirements: Approximately 20% (national)

#LI-AS1 #Hybrid

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

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