Director, Compliance at Veloxis Pharmaceuticals, Inc.

Posted in Other 10 days ago.

Location: Cary, North Carolina

Job Description:

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.


Veloxis Pharmaceuticals, Inc.

Job Description:

This position contributes to the Company's success by serving as a Compliance Navigator/Advisor to various areas of the business, with a particular focus on supporting the commercial organization (Marketing, Sales, etc.). The incumbent will conduct day-to-day risk assessment and management to help support the Company's compliance vision by embedding ethical and risk-informed decision-making into the organization. This role is expected to be the key liaison and primary point of contact for compliance-related topics to assigned areas of the business, including headquarters- and field-based commercial teams. The incumbent will integrate practical compliance best practices within business processes. In addition, the incumbent will synthesize learnings from partnerships across business functions to develop innovative and agile methods to better identify compliance risks and enhance monitoring opportunities. The incumbent will also be expected to inspire proactive collaboration throughout the organization, enable business ownership of risk, and prioritize for impact.

Key Activities to be reviewed

  • Dissemination of Off-Label Information

  • Provision of Consulting Services

  • Contractual Payments/Arrangements

  • Clinical/Research Study and Educational Grants

  • Medical Education Programs

  • Professional Service Agreements with Physicians

  • Discretionary Spending

  • Sampling and Free Goods

  • Product Trials

  • New Industry Marketing Code

Summary of Key Responsibilities

  • Subject Matter Expert on "Code on Interactions With Health Care Professionals" by PhRMA, and all relevant Federal and State laws governing compliance.

  • Manage the Company's compliance policies, guidance, and SOPs in accordance with its growing and evolving business needs and applicable regulations.

  • Identify new and emerging risks within the business and respond with a risk posture calibrated to business needs and growth imperatives.

  • Responsible for State, Federal and international compliance reporting responsibilities.

  • Maintain State licensing requirements and renewals, as applicable.

  • Utilize a risk-based, top-down approach to catalog existing policies and procedures, identify gaps, assess adequacy, recommend best practices, and verify that actual operating practices are consistent with the Company's existing policies and procedures.

  • Manage the Company's compliance efforts relating to its internal Code of Conduct, anti-bribery/anti-corruption laws (U.S. Foreign Corrupt Practices Act, UK Bribery Act and other OUS statutes), FDA regulations, False Claims Act, anti-kickback statutes, OIG guidance relating to interactions with HCPs, PhRMA Code and other applicable laws and regulations (including U.S. Physician Payment Sunshine Act and other international statutes and requirements, promotional and marketing regulations, and government reimbursement.

  • Design and deliver meaningful and effective compliance training to Company employees.

  • Conduct spot or Company-wide audits of the Company's compliance program.

  • Outline peer benchmarks and best practices to establish compliance program goals and objectives, create a long-term strategy and structure, and establish metrics and monitoring processes to demonstrate effectiveness over an expanded mandate.

  • Supervise compliance investigations from intake to resolution; collaborate with other functions and departments to provide recommendations; and ensure that corrective actions are implemented.

  • Organize the Company's Compliance Committee meeting on a regular basis in collaboration with the Company's Chief Compliance Officer and VP, Legal Affairs and General Counsel. Maintain meeting minutes, outlining topics discussed and recommendations/actions.

  • Oversee compliance regarding the Company's interactions and arrangements with HCPs, including medical education, clinical trials, and investigator-sponsored research.

  • Manage the Company's' privacy program, including HIPAA and GDPR compliance in conjunction with other relevant stakeholders.

  • Provide compliance oversight and participate, as required, in the review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations, and patients/advocacy groups.

  • Conduct periodic internal reviews, risk assessments, monitoring, and auditing to ensure that compliance policies and procedures function as intended so that the Company identifies potential compliance risks and remediates where necessary.

Required Qualifications and Skills

  • BA/BS. JD, PhD, PharmD, MD/DO a plus.

  • Minimum of 4 years of relevant compliance experience in pharmaceuticals/biotech, preferably 8 years of compliance experience in a healthcare setting. Some prior experience in pharmaceutical sales and/or marketing, desirable.

  • 4+ years of advertising and promotional materials' review experience, required.

  • Experience with a global life-sciences company or healthcare consulting firm with emphasis in life sciences.

  • Solid 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 Sales, Medical and Market Access teams.

  • Ability to prioritize and direct limited resources to the most critical areas and issues; build 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 have cross-constituency facilitation skills.

  • 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 10-15% (national)


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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