Director, Corporate Compliance

Role Summary

As a leader and a trusted Business Partner, the Director of Corporate Compliance will have overall responsibility for the commercial and medical affairs teams by providing timely compliance advice and measured guidance as a strategic business partner ensuring compliance requirements are integrated into business processes. This role is critical to fostering a culture of compliance throughout the organization while enabling the organization to make informed decisions to meet long-term goals.

Responsibilities

As the liaison between the compliance department and the commercial and medical affairs teams, this role will be responsible for achieving organizational objectives by effectively integrating into the business to drive compliant activity.

• Collaborate: Establish strong working relationships and act quickly to ensure timely thoughtful advice is provided to key business partners.
• Educate: Develop and deliver targeted training to enable informed decision making in support of the needs of the business unit.
• Monitor: Assess activities to ensure alignment with healthcare compliance requirements.
• Detect: Identify areas of compliance risk within respective business areas to ensure systems, processes, training and other resources are coordinated to help mitigate risk.
• Strategize: Embrace inherent risks associated within the industry and develop and implement strategies that recognize these risks as necessary for impactful innovation.
• Evaluate: Pursue options and evaluate strategies and technology to enhance business processes.
• Adapt: Adjust compliance strategies in response to regulatory changes, compliance trends and best practices while ensuring the organization remains agile and compliant.
• Challenge: Question conventional compliance models and practices and help drive innovation on appropriate approaches to the evolving landscape and dynamic regulatory environment.
• Other duties as assigned.

Qualifications

• Required: Bachelor's degree with at least 15 years of compliance-related experience
• Required: Previous experience as a compliance business partner in the pharmaceutical industry
• Required: Up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct (e.g., OIG Compliance Program Guidance; PhRMA Code)
• Required: Demonstrated ability to critically analyze and assess business and regulatory information and effectively communicate at all levels within the organization
• Required: Strong analytical skills and ability to successfully manage, synthesize and communicate complex information in an effective manner
• Required: Ability to work independently, identify opportunities, explore options and recommend solutions through strong critical thinking, problem solving and decision-making skills
• Required: Experience with change management working in a high growth environment
• Preferred: Advanced degree such as master’s or Juris Doctor
• Preferred: Certification of Healthcare Compliance (CHC) and Certified Compliance and Ethics Professional (CCEP)
• Preferred: Experience with clinical stage compliance issues

Additional Requirements

• Physical Demands And Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
• Travel: You may be required to travel for up to 20% of your time.