Director of Compliance

Profile

About the Role:
The Director of Compliance will lead AdhereTech’s overall compliance program and will be responsible for ensuring all requirements are met through ongoing development and expansion of our current program, including compliance with HIPAA/HITECH,GDPR and FDA requirements, and state marketing compliance laws, etc. This person will work hand in hand with both internal and external stakeholders in ensuring that our compliance program meets all policies, laws, and requirements that impact business operations while maintaining alignment with the organization’s business objectives. The Director of Compliance will be responsible for interpreting, communicating, and implementing compliance requirements and expectations throughout the organization and advising leaders on compliance best practices, along with the implementation of appropriate compliance and privacy risk mitigation strategies. This position reports directly to the General Counsel.

Responsibilities:
 

• Develop company compliance policies and procedures as well as provide on going training on compliance to all necessary employees
• Establish and implement current and forward looking compliance policy consistent with identified risk areas relative to industry standards.
• Ensure all applicable departments/functions are operating within SOPs; update SOPs as required.
• Conduct focused audits of identified risk areas
• Review business rules, documents, marketing materials and information to ensure compliance with regulatory agencies, federal and state laws.
• Be the expert compliance resource for the organization to advise on compliance issues that may require interface with multiple federal or state laws, regulations, or agencies.
• Partner with AdhereTech customers and partners, including pharmaceutical manufacturers, specialty pharmacies, health plans and PBMs, in navigating regulatory and compliance requirements and guidelines
• Ensure that all regulatory requirements are consistently met in an appropriate manner that allows AdhereTech to best service patients and advance the business
• Communicate AdhereTech’s compliance achievements to the relevant external stakeholders, whether prospective customers or existing clients
• Develop and implement the activities necessary to demonstrate an effective compliance program, including but not limited to auditing and monitoring activities. Maintain compliance reporting documentation systems, including any reporting obligations to external stakeholders
• Develop, maintain, enhance and administer effective compliance training programs through various delivery formats that focus on the elements of the compliance program and seek to ensure that appropriate employees understand pertinent requirements
• Serve as a subject matter expert in areas of healthcare compliance, including FDA regulations, HIPAA, TCPA, GDPR, and all applicable fraud, waste and abuse laws, rules and regulations.
• Oversee quality, regulatory, and compliance team members
   

Qualifications:
 

• BS or MS degree or other applicable degree (e.g. JD)
• Certification (e.g. CCP or CMDCP or other applicable compliance certification) helpful
• Minimum 10 years of compliance experience in pharmaceutical industry preferred, healthcare and medical device experience also considered
• Minimum 5 years of experience in a leadership position managing team members and/or advising c-suite executives
• Detail oriented with excellent verbal and written communication skills
• High-level of familiarity with a broad range of compliance risk areas relating to commercial practice of a pharmaceutical entity.
• Based in NYC
   

Why Join AdhereTech

AdhereTech is changing the way patients take and manage their most crucial medications. We partner with many of the world’s largest healthcare companies to improve the care of tens of thousands of patients one dose at a time.

AdhereTech’s mission is to constantly improve the patient experience, by building software and devices that seamlessly connect patients to care. On the highest level, AdhereTech’s product intelligently delivers automated scalable support to patients' phones (text or voice), driven by real-time data from our patented smart devices. On a much deeper level, the product balances the priorities of many unique parties with whom we work: For patients, it provides a world-class daily experience, while being simple, beneficial, pleasant, and engaging. For pharmaceutical companies and pharmacies, it seamlessly-integrates care support and data that identifies, evaluates and escalates when and what patients need in real-time.

AdhereTech is an Equal Opportunity Employer. AdhereTech provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. AdhereTech complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.



 

Company info

Digital Medical Technologies, LLC