New Providence, NJ

Position Overview:

We are looking for an energetic, commonsensical and experienced individual to lead our corporate compliance team and oversee and manage compliance within our organization.

Reporting to the Chief Legal & Compliance Officer, this position will be responsible for implementation and oversight of ADCT’s global corporate compliance program including healthcare compliance and transparency reporting. The incumbent in this role will be required to assess compliance, business, and implementation risk and advise on a path forward which supports business objectives while maintaining the ethical and compliance standards of the Company. This role will support development of written policies and procedures, leading effective compliance training programs, liaising with business partners, developing, and executing monitoring and auditing plans, and assisting with investigation, and overall ownership of the compliance responsibilities.

The role will include (but is not limited to): managing the compliance function at the direction of the CCO, setting and developing policies, managing training, overseeing and implementing compliance requirements, working with compliance vendors, monitoring and auditing compliance programs, policies and processes. This person will be responsible for managing the processes and controls required for compliance and industry best practices. This individual will be a key business liaison to all business functions on compliance operational issues.

While the team works primarily remotely, our preference is a candidate who can come to the New Providence, NJ office on a regular basis for in-person meetings and other business needs.

Core Responsibilities:

• With input from the CCO/CLO, lead compliance strategy and operations for the Company.
• Provide leadership and guidance on compliance across business functions. Oversee and manage all compliance related matters within the organization.
• Assist with the design and manage the execution of compliance auditing and monitoring programs, investigations frameworks and practices, enforcement and discipline as well as risk response and prevention practices.
• Work with the Data Privacy Officer to implement, train and oversee privacy policies and documentation.
• Maintain and manage employee, third-party vendor, and new hire compliance training.
• Manage compliance budget and compliance consultant arrangements.

Healthcare Compliance Responsibilities

• Serve as business partner to the commercial and medical affairs organizations, understanding business objectives and advising on effective ways to meet the objectives in a compliant manner. Participate in leadership team meetings.
• Identify potential risk areas and develop plan of action to address, working closely with legal and other functions.
• Develop and implement effective new healthcare compliance policies, procedures, and other resources like job aids.
• Maintain training plan for new commercial and medical affairs employees and a corporate plan for all corporate policies. Assist in the creation and delivery of training content.
• Develop and implement annual communications plan for policies, training and the company hotline.
• Establish and implement auditing and monitoring plan for commercial and medical affairs activities including documentation and supporting system(s).
• Ensure debarment checks occur in a timely manner for all key stakeholders.
• Support/Lead investigations of non-compliance, as requested.
• Evaluate needs assessments for HCP engagement activities.
• Identify continuous improvement opportunities for the ADCT Compliance Program.
• Manage transparency reporting manager, and the filing of federal, state, and country-level transparency reports.
• Perform other compliance-related activities as directed.
• Maintain current understanding of compliance legislation and regulations to ensure adherence to requirements.

Job Requirements:

• Bachelor’s degree required
• JD or law degree or equivalent preferred
• 15+ years of relevant healthcare industry experience with a minimum of 8 of those years in pharmaceutical, medical device or biotech company; previous compliance officer experience is a plus.
• Experience in building and implementing key components of an effective compliance program, including written standards, training, monitoring and auditing, hotline and investigations.
• Experience in risk assessment, issue spotting, and risk mitigation
• Knowledge/Experience with federal, state, and country-level transparency reporting.
• Ability to establish rapport at all levels of the organization and skilled at navigating conversations with varying opinions.
• Self-motivated, strong project management and decision-making skills
• Ability to stand up to challenges and convey rationale for advice being provided.
• Demonstrated ability to work independently, cross-functionally and collaboratively
• Excellent written and verbal communication skills
• In-depth knowledge of applicable regulatory and compliance requirements (i.e., FDA, OIG, Anti-Kickback Statute, False Claims, HIPAA, GDPR, FCPA).
• Travel – approximately 5% a year – domestic

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.

Apply Here: https://www.click2apply.net/AK4XNWcNLKa6BHkQMUXkYN

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