Director of Compliance

POSITION ID: DIRCOMPL 1269
CATEGORY:
PRACTICE AREA: ,
LOCATION: New York
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Princeton Legal Search Group has been engaged on an exclusive basis by a growing software and data company in New York that uses patented smart devices to create patient support programs. We are leading the search for a Director of Compliance.

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 Company 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 the Company to best service patients and advance the business
  • Communicate the Company’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)
  • Minimum 5 years of compliance experience in pharmaceutical industry preferred, healthcare and medical device experience also considered
  • Experience 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.
  • Certification (e.g. CCP or CMDCP or other applicable compliance certification) helpful
  • Experience leading a team is a plus
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