Compliance Director, US

POSITION: Compliance Director U.S.  

The salary range for this position is between $210,000 and $240,000.

Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience. The company also currently offers a Long-Term Incentive Plan (cash plan) between 20%-25% base salary, annual performance bonus target of 20%-25% base salary (subject to meeting plan requirements) and comprehensive health benefits (employer funded), unlimited vacation time and 401k plan (subject to change or modification from time to time).

POSITION SUMMARY

Reporting directly to the U.S. Compliance Officer, the successful candidate in this role will partner with senior Averitas leaders across Commercial, Medical, Regulatory, Legal, Finance, HR and other functions to help build and lead all aspects of the United States Compliance function.  Further, you will work closely with our Global Compliance, Audit and Corporate Responsibility team members, as well as our Boston Hub Leadership Team (“BIH”).  You will also be expected to represent Averitas through interactions with HCPs, customers, law firms, consultants, and other entities.

More specifically, you will be able to develop and nurture trusting relationships with all internal and external stakeholders, especially senior leaders.  This will help you identify executional risk at as early of a stage as possible.  You will then collaborate with pertinent internal stakeholders to develop ways to help mitigate associated risk appropriately.  You will also operationalize risk mitigation plans developed with the business in the context of appropriately maximizing business opportunities.  You will also help operationalize decisions reached by developing simple, easy to understand policies and procedures (“P&Ps”).  Then you will develop and lead training efforts on these P&Ps that leverages the best in adult learning principles to help effectuate any desired behavioral change.  You will also develop and leverage auditing, monitoring, and data analytic approaches to monitor adherence to these P&Ps and other guidance's.  You will also ensure that internal stakeholders remediate any deviations from the P&Ps in a timely, appropriate and well-documented manner.  In the context of investigations, you will be responsible for developing and leading all aspects of the investigations process in collaboration with your U.S. Compliance teammates and in the context of our global compliance investigations framework.   

You will be able to perform these responsibilities through the lens of, and belief in, the shared responsibility between the business functions and Compliance for company success, which includes compliant and ethical behavior.

KEY RESPONSIBILITIES

• Co-develop and continually refine the strategy of the overall Compliance Program in the U.S.
• Establish and lead a region-based Compliance Champions network to help pull through the Compliance efforts in the regions, with a goal of integrating them into the business decision-making process of the regions.

• Assist the U.S. Compliance Officer in leading the quarterly Management Ethics & Compliance Committee meetings, including developing the agenda, presenting the same, and follow up.

• Develop and oversee our U.S. Privacy initiatives, including some OUS aspects (e.g., GDPR) in conjunction with internal and external partners.

• Develop simple, easy to understand P&Ps that enable the functions to most efficiently, effectively and productively perform their jobs while adhering to our high ethical standards in all areas of our operations. Help ensure that our training records are captured and stored in an accurate, complete and timely fashion (in our LMS).

• Lead our training efforts to effectuate the desired behavioral change or maintain the already established behaviors. Leverage adult learning concepts in creating a cutting edge, engaging, yet highly impactful set of training materials, including gamification, live trainings via web and F2F, recorded/enduring materials trainings, etc. This key responsibility will also include developing and presenting training and presentation material for national meetings and other live presentations, working with outside vendors and internal partners in most of these situations.
• Develop and conduct risk assessments (along with teammates) utilizing review and analysis of government enforcement and guidance trends, other program benchmarking, internal interviews, and other pertinent information/data. Use these assessments to help identify the significant areas of risk for our company, present to internal stakeholders, including senior executive audiences.

• Oversee the development and refinement of the auditing and monitoring plan, building from the risk assessment and engaging in auditing and monitoring activities as well.

• Oversee the Compliance budget, including helping to determine the allocation of budget dollars for specific activities.
• Develop and lead all aspects of the investigations process in collaboration with your U.S. Compliance teammates and in the context of our global compliance investigations framework. This will include developing an associated P&P, enhanced investigation report templates, and overseeing all aspects of the investigations database.

QUALIFICATIONS, CAREER EXPERIENCE AND SKILLS  

• Qualifications
  • Bachelor’s degree required
  • Advanced degree preferred (e.g., JD, MBA, CPA)
    • Legal degree and experience preferred
  • Compliance certification(s) preferred
  • Well versed in understanding of, and ability to apply in “real world” settings, relevant U.S. pharmaceutical industry compliance, guidelines, regulations, and pertinent settlements (AKS, FCA, HIPAA, FDCA, FCPA, PhRMA Code)
• Career Experience
  • Eight years or more of experience in Compliance roles, preferably in the life sciences space
  • Significant experience in managing large, enterprise-wide initiatives, and also managing people, preferred
  • Some sales experience in any field, preferably life sciences, preferred
  • Experience in multinational companies preferred
  • Experience conducting developing and conducting training experiences in front of large audiences, including senior executives
  • Excellent written communication skills (writing sample may be requested)
  • Strong awareness of, and proven ability to, appropriately leverage technology solutions risk-based strategies, ethical frameworks
  • Strategic and creative mindset
  • Strong in translating excellency in strategy into excellency in practice
• Culture and leading teams
  • Demonstrated ability to appropriately influence business decisions
  • Demonstrated excellence in leadership behavior, networking, collaboration, and communication skills
  • Demonstrated ability to lead and support successful cross-functional teams in evolving competitive landscape
  • Effective interpersonal and presentation (written and verbal) skills that can translate to team members
  • Proven experience in leadership and people development as well as competent and assertive leadership behavior
• Business Acumen
  • Ability to work across multiple functions is essential
  • Capability of working in multinational environment is a given
  • Proven critical thinking capabilities, analytical skills, and a proactive approach
  • Excellent written and verbal communication and strong presentation skills required
  • Adaptability and agility in a dynamic environment with proven ability to work in teams and independently
  • Sense of urgency in sharing critical information with relevant stakeholders
  • Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines
  • Flexibility in prioritizing work and ability to thrive in a rapidly changing environment with a keen ability to identify opportunities for process improvements
• Professional Skills
  • Proven ability to work in a dynamic, agile, and fast-paced environment.
  • Proven communication and collaboration skills

ETHICS AND COMPLIANCE

• Demonstrates the highest level of ethics, integrity, trust while acting with courage and candor
• High accountability for your actions and results and ability to ensure a high level of commitment to the success of the organization, your peers, and customers
• Operates in compliance with all applicable regulations and professional standards at all times

TRAVEL

• The ability to travel up to 25%, including overnights, as dictated by business need across USA and at times internationally
• The duties of this role are generally conducted in an office environment
• This position may operate out of our headquarters based in NJ or be remote.

VALUES AND BEHAVIORS

• Live Entrepreneurship: Plan for long-term growth and build a future business predicated on innovation.
• Patient Centric: Deliver innovation for patients and challenge each other to improve patient outcomes.
• Join Forces: Seek diverse input, collaborate across all functions, and leverage resources from global partners.
• Act with Integrity: Apply ethical standards, encourage transparency, and embrace diversity and inclusivity.
• Drive Performance: Create an atmosphere that nurtures teamwork in order to enable high performance and sustainable growth.

Salary : $210,000 - $240,000