Location: New Haven, CT (Northeast preferred)

Position summary: 

Invivyd is seeking an experienced healthcare compliance professional to join the Ethics & Compliance Team, reporting to the Vice President, Chief Ethics, Compliance & Privacy Officer.  This individual will play a critical role in designing, building, implementing, and maintaining an effective compliance program that embeds a culture of compliance across all levels and departments of the organization.  The role will involve hands-on program development and collaboration with business partners to ensure Invivyd is well-positioned to comply with healthcare-related laws, regulations, industry codes, and the Company’s Code of Business Ethics and Conduct. He/she will assist in the creation and update of policies and training, conducting monitoring and risk assessment, and other aspects of an effective compliance program.  Ideally, this role will also support and oversee privacy compliance, data governance and strategy, and privacy incident management and response.  Ultimately, this professional will help shape the company’s culture to enable achievement of its goals in a compliant and ethical manner.   

Responsibilities:   

• Policies:
  • Work collaboratively across the business to help develop, evolve and oversee implementation of policies, procedures, and guidance that are right sized for Invivyd and reflective of existing and updates to applicable laws, rules, regulations, guidance, industry codes, and Company policies
  • Periodically update relevant policies and procedures, ensuring they are appropriately tailored to the risks associated with the business
• Privacy:
  • Lead or assist in the development of a comprehensive privacy program, right-sized for Invivyd and counsel internal clients on a wide range of privacy matters, including permissible data uses for strategic initiatives and the application relevant privacy laws and regulatory guidance to current business processes, research collaborations, and commercial partnerships
• Training, Communications, & Culture
  • Develop and implement engaging communications, trainings, and other content to help employees understand company policies and guidance and be accountable for their role in building and maintaining a compliant and ethical organization
  • Assist in the development and roll-out of Compliance training and communication to Sales, Marketing, Market Access, Medical Affairs, and other relevant departments
• Monitoring:
  • Assist in the execution of a comprehensive compliance monitoring program relevant to each business function, including periodic field rides, observation of speaker programs, advisory boards, and sponsorship activities
• Systems:
  • Manage implementation and deployment of Compliance systems (e.g., end-to-end HCP engagement tools, sponsorship submissions and approvals) and coordinate with vendors, third parties and others to support the development, implementation, and maintenance of the compliance program
• Risk Assessments:
  • Support the design and execution of compliance risk assessments
• Culture, partnership, and guidance:
  • Foster a strong internal compliance, ethics, and “speak-up” culture by creating an environment in which employees see Compliance as a strategic partner
  • Provide advice and counsel to business partners from across the entire organization, evaluating business strategies and tactics for potential compliance risks
• Operations:
  • Assist in review and authorizing transactions where indicated by company policies, including HCP engagements and commercial sponsorships
  • Assist in preparation for compliance committee meetings
  • Provide additional support for ethics & compliance strategies and goals

Requirements:  

• Bachelor's degree in a relevant field
• Compliance and/or Legal background with a strong business partnership orientation; law degree or compliance certifications a plus
• Eight or more years of experience in U.S. healthcare compliance experience in pharmaceutical industry
• Subject matter experience with relevant laws and regulations, including:
  • U.S. anti-kickback laws and regulations, including the Federal Antikickback Statute
  • The Physician Payments Sunshine Act
  • Laws and regulations governing pharmaceutical industry
  • US privacy and consumer protection laws
  • The PhRMA Code on Interactions with Healthcare Professionals.
• Experience conducting internal monitoring
• Knowledge of commercial, compliance and regulatory matters related to the launch and subsequent commercialization of branded pharmaceutical products
• Knowledge of compliance and data privacy laws and standards, including but not limited to AKS, Sunshine Act, OIG HHS Compliance Program Guidance, HIPAA, and state privacy laws
• Ability to develop strong working relationships and work effectively with cross-functional teams, multiple levels of management, external advisors, and others
• Must be able to travel to the corporate office 2-4x/month
• Ability to periodically travel (approximately 20%)

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