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Senior Director, Compliance

Senior Director, Compliance

Sydnexis IncUS
30+ days ago
Job type
  • Full-time
  • Quick Apply
Job description

About Sydnexis :

  • Sydnexis Inc. is a clinical-stage biopharmaceutical company united by a single purpose : helping children see clearly.
  • We are developing a proprietary, stable, topical eye drop designed to slow the progression of myopia, a disease that affects more children today than ever before.
  • Our team has filed a New Drug Application (NDA) with the FDA for our patented formulation, marking an important milestone in redefining the standard of care in pediatric eye health.
  • At our core, we believe every child deserves the chance to see their world, and their future, with clarity.
  • This belief drives us every day.

When you join Sydnexis, you become part of a mission bigger than any one of us :

  • to challenge outdated standards, disrupt the status quo, and deliver innovations that truly matter.
  • Here, you’ll find a tight-knit, purpose-driven team building something extraordinary together, and the opportunity to make a lasting impact on children’s lives.

    • Position :

  • As the Senior Director of Compliance, you will play a critical role in supporting the organization’s commitment to ethical business practices and regulatory compliance as we prepare for our first potential commercial launch.
  • This position oversees compliance initiatives related to Fair Market Value (FMV) payments, Transfer of Value reporting, price transparency reporting, auditing and monitoring, investigations, training, and policy development.
  • The role requires collaboration across various functions, including Business Operations, Finance, IT, Contracts, Market Access, and other stakeholders, to ensure adherence to federal, state, and global regulations.

    • Role and Responsibilities :

  • Oversee the Fair Market Value (FMV) assessment process to ensure that payments to Eyecare professionals (ECPs) comply with regulatory requirements and company policies.
  • Ensure compliance with state price transparency reporting laws in partnership with Market Access.
  • Provide compliance oversight for activities such as investigator-initiated trials, sponsorships, grants, and advisory boards.
  • Implement auditing and monitoring programs to proactively identify and mitigate compliance risks in interactions with ECPs and in commercial activities.
  • Lead and support internal investigations related to potential compliance violations, ensuring thorough documentation, root cause analysis, and the implementation of corrective actions.
  • Conduct risk-based compliance assessments to evaluate the effectiveness of policies and controls, and report findings and recommendations to leadership.
  • Develop and deliver compliance training to employees, ensuring they understand the compliance risks and regulatory obligations specific to the biotechnology industry.
  • Create and update company compliance policies and procedures in response to changes in the regulatory environment and enforcement landscape.
  • Provide strategic guidance on emerging healthcare compliance risks, including clinical trials, patient support programs, expanded access programs, and commercialization strategies.

    • Qualifications :

  • J.D. degree from an accredited law school.
  • Over 10 years of work experience, including more than 5 years in compliance or regulatory roles within the biotech, pharmaceutical, or life sciences industries.
  • Strong knowledge of U.S. and global healthcare compliance regulations, including HIPAA, the Anti-Kickback Statute, the False Claims Act, the Sunshine Act, and state price transparency laws.
  • Experience with Fair Market Value (FMV) assessments, Transfer of Value (TOV) reporting, price transparency regulations, and industry compliance best practices.
  • Proven ability to design and deliver compliance training programs.
  • Strong investigative skills, with experience in auditing, monitoring, and risk management.
  • Excellent communication, analytical, and interpersonal skills, with the ability to work effectively across functions.
  • Adaptability and a growth mindset, providing practical compliance solutions to complex challenges.
  • This position is remote and requires occasional travel for business purposes.
  • Sydnexis Inc. is an Equal Opportunity Employer.
  • We are committed to providing a work environment free of discrimination and harassment.
  • We do not discriminate based on race, color, religion, sex, national origin, age, disability, genetic information, or any other characteristic protected by federal, state, or local law.
  • We are also committed to making our hiring process accessible to individuals with disabilities and will provide reasonable accommodations upon request.   Powered by JazzHR
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