Director, Compliance- Remote- US

Job description

Join Amplity, the full-service go-to partner of biopharma companies that delivers flexible + specialized medical + commercial services. No matter where a drug is in its lifecycle, we scale with ease to maximize resources + improve impact for all our clients. Through strategic partnerships + deep therapeutic expertise, Amplity transforms how breakthrough treatments reach the people who need them. The Director, Compliance is responsible for the day-to-day operation of Amplity’s healthcare compliance program. Reporting to the Chief Compliance Officer, the Director executes the compliance program through monitoring and auditing, training, investigations, policy management, transparency reporting, and client-facing compliance support. The Director is a client-facing role and serves as a primary point of contact for compliance questions from field, medical, commercial, and corporate teams. Duties and Responsibilities Reporting to the CCO, the Director, Compliance: Designs, develops, revises, and maintains a comprehensive set of compliance-related policies and procedures and associated employee training and education aligned to ever-changing laws, regulations, industry codes, and client contractual requirements. Designs, develops, and implements ongoing monitoring to prevent, detect and respond to compliance issues, including the creation and implementation of an annual compliance work plan and a three-year audit plan., including: Conduct targeted monitoring activities: expense and meal reviews, HCP interaction reviews, call/activity data reviews, and program-level assessments. Analyze results to identify trends, control gaps, and emerging risks; escalate findings to the Chief Compliance Officer. Track remediation to closure and confirm effectiveness of corrective actions. Support periodic compliance program effectiveness assessments consistent with DOJ and OIG guidance. Intake, triage, and investigate allegations of non-compliance, including hotline reports. Conduct interviews, gather documentation, and prepare well-supported investigation reports. Recommend and drive corrective and preventive actions, including disciplinary recommendations in coordination with Human Resources and Legal. Maintain the investigations log and related metrics; identify root causes and systemic issues. Serve as compliance point of contact for pharmaceutical and biotech client compliance counterparts. Support client audits, questionnaires, due diligence requests, and program start-up compliance requirements. Review program design and client-directed activities for consistency with Amplity policy and applicable law; escalate conflicts between client direction and Amplity standards. Prepare materials and metrics dashboards for the Compliance Committee and senior leadership. Maintain KPIs across monitoring, training, investigations, and transparency reporting. Support Board-level and executive compliance reporting Act as Compliance subject matter expert for pitch presentations and RFP completions Prepare and distribute company-wide healthcare Compliance updates Host, support, and respond to client audits; negotiate and implement any resulting corrective action plans. System administrator for web-based, department-specific training for selected employees. Assists the CCO with other issues, as needed Supervises the Compliance team, allocating workload and ensuring quality and timeliness of team deliverables. Qualifications and Requirements Education and Experience: Bachelor’s degree from accredited college or university. Five (5) or more years of experience in healthcare compliance experience within the pharmaceutical, biotechnology, or pharmaceutical services industry Three (3) years experience conducting compliance investigations, including addressing complaints and resolving problems. Working knowledge of the federal Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, FDA promotional regulations, HIPAA, the PhRMA Code, OIG compliance program guidance, and state transparency and marketing laws. Demonstrated experience conducting compliance investigations and documenting findings. Demonstrated experience building and delivering compliance training. Experience designing and executing monitoring and auditing activities. Necessary Knowledge, Skills, and Abilities: Strong written and verbal communication skills, including the ability to advise business stakeholders and interact with client compliance personnel. Ability to exercise sound, independent judgment and maintain confidentiality. Working knowledge of applicable laws, regulations and rules related to the promotion of pharmaceutical and other healthcare products. Ability to manage multiple concurrent priorities in a fast-moving environment. High ethical standards and exceptional judgment. Superior interpersonal skills. Proficiency in Microsoft Word, Excel, and PowerPoint. Comfort operating with autonomy in a remote setting Preferred Qualifications: Certification in Healthcare Compliance (CHC) or Certified Compliance and Ethics Professional (CCEP). Experience in an outsourced or contract commercial/medical services environment supporting multiple pharmaceutical clients. People management experience. Experience supporting product launches and field-based teams. EPIIC Values: All positions at Amplity have a responsibility to demonstrate our EPIIC Values in order to uphold our high-service standards. Excellence : We set high standards. We are solutions-focused and achieve outstanding results with a professional and positive attitude. Passion : We love what we do. Our energy inspires, engages, and motivates others. Innovation : Our ideas set us apart. We are curious and bold and challenge traditional ways of working. Integrity : We are open, honest, and transparent. We do the right thing with courage and understanding. Collaboration : We are better together. We actively seek the participation of others to achieve greater outcomes. About Us Amplity powers biopharma innovation through expert-led teams that deliver. Whether you knew us in the 80’s as Physician Detailing Inc., or in the 00’s as part of Publicis Health , the companies that came together in 2019 to form Amplity have delivered contract medical, commercial + communications excellence for 40+ years. Our people-driven, tech-enabled DNA fuels everything we do. Our professionals understand the pharmaceutical industry from the inside out. With a deep grasp on product lifecycles, marketing hurdles, operational nuances + the complex needs of providers and patients, we help our clients launch products + operate smoothly with precision — across all business shapes, sizes + specialties. We are on a mission to improve patient outcomes through executional excellence — enabling our partners in pharma to thrive in turn. At Amplity, we are allies in excellence. And we do it quicker, better, nicer than anyone else. Our Diversity Policy We encourage and support equal employment opportunities for all associates and applicants for employment without regard to sex, race, color, religion, national origin, age, disability, marital status, sexual orientation or veteran status. Employment decisions are evaluated on the basis of an individual's skills, knowledge, abilities, job performance and other qualifications. In addition, Amplity Health maintains policies and procedures designed to comply with applicable federal, state and local laws governing non-discrimination in employment in every location in which Amplity Health has facilities.