VP, Deputy Compliance and Privacy Officer

Overview

The VP, Deputy Compliance and Privacy Officer is principally responsible for architecting, integrating, managing, and overseeing Compliance and Privacy initiatives across Xeris.  This role establishes and implements the Company’s ethics and compliance and Privacy programs to foster a culture of high integrity and ensure there are adequate programs to manage global compliance, investigation, and reputational risks, while striving to drive competitive advantages. This role elevates, drives and ensures full implementation of the 7 elements of an effective Compliance program as set forth by the US Department of Justice and sets the vision and strategy for the function in the US, and international where required, within the context of the larger Xeris enterprise, shape and influence the organization’s strategy, augmenting collaboration and synergies, co-creating and developing Compliance and Privacy policies, practices, culture, education and awareness.

Responsibilities

• Develop and execute a comprehensive compliance strategy aligned with corporate objectives and industry regulations.
• Serve as the primary compliance advisor to the senior leadership team, providing updates on compliance risks, trends, and mitigation strategies.
• Builds and develop the Compliance team. Identify skill and resource gaps on the team to support the company’s goals, develop long-term plan to address gaps and then execute the plan.
• Be the expert in all aspects of commercial compliance and work with internal business partners focusing on the emerging risks areas of privacy, national and regional accounts, channel strategy and accounts, payor marketing, pricing and access strategy, specialty pharmacy, specialty therapeutic areas (such as oncology, biosimilars or orphan drugs); payor and distributor contracting, HUB and reimbursement services, co-pay cards, specialty pharmacy data services, and nurse educators and other nurse-based services.
• Identify, create, and implement novel approaches to mitigate risk.
• Implement and manage the development of programs to prevent and detect violations of laws and company policies (e.g., Code of Conduct)
• Promotes ethical practices and ensures the implementation and maintenance of the compliance program throughout the organization
• Works closely with all corporate divisions and commercial teams to ensure ethics and compliance objectives/initiatives are part of all strategic business initiatives
• Maintains up to date knowledge of applicable laws, FDA regulations and industry guidance that affect the Company’s business
• Develops and maintains effective relationships with third party vendors in the area of compliance
• Conducts periodic reviews and updates to ethics and compliance policies and procedures, ensuring clarity, applicability and alignment with higher level policies and external requirements
• Identifies potential areas of compliance vulnerability and risk; implements corrective action plans for resolution of problematic issues; and provides guidance on how to prevent or address similar situations in the future
• Organizes company-wide ethics and compliance training for all employees on both corporate and pharmaceutical commercial compliance programs
• Serve as lead privacy counsel to global functions in connection with business activities (e.g., ecommerce and digital initiatives), manage outside privacy counsel and support the professional development of Legal colleagues in this area
• Lead strategy and implementation of the company’s Global Privacy & Data Protection Policy and related procedures, including notice and consent requirements, vendor due diligence, etc.
• Lead associate and vendor training and other communications efforts in this area including through targeted efforts and as part of Global Ethics & Compliance training
• Conduct formal and informal privacy risk assessments from time to time to ensure the company's resources in this area are appropriately targeted against the risks
• Revise and implement privacy policies for the Company as domestic and international regulations evolve

Qualifications

• Bachelor’s degree, Master's degree r(e.g., MBA, MSc) in Business Administration required. Legal and/or Doctoral degree(s) (e.g., JD, PhD or LLM) in Law highly preferred.
• Minimum of 10-12+ years of business experience in the US Pharma, Medical Device or related life science area with a focus on privacy, commercial compliance, medical affairs compliance, specialty and/or market access functions.
• Industry certifications a plus - (e.g., HCCA or SCCE)
• Must possess excellent knowledge and understanding of pharmaceutical industry regulations and guidelines within the US and EU (e.g. PhRMA Code, Federal Anti‐Kickback etc.); knowledge of non- European regulato