Director, Compliance

Cosette Pharmaceuticals, Inc. is a U.S.

-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast‑growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women’s health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms—including topical creams, ointments, oral liquids/solutions, and suppositories—which has led to consistent supply to customers and commercialization success.

The company has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

The Director, Compliance leads the day‑to‑day design, implementation, and continuous improvement of Cosette Pharmaceuticals’ enterprise compliance program under the direction of Cosette’s General Counsel & Compliance Officer (GC/CO). The Director serves as the senior operational leader of the compliance function, partners closely with the GC/CO on Compliance Committee operations and reporting to the CEO and the Audit Committee, and is the company’s primary day‑to‑day owner of operational compliance with the U.S. healthcare fraud and abuse laws (including the Federal Anti‑Kickback Statute and the False Claims Act), the Federal Food, Drug, and Cosmetic Act and FDA advertising and promotion requirements, federal and state drug‑price transparency and aggregate‑spend reporting obligations, the Prescription Drug Marketing Act (PDMA), federal exclusion/debarment screening, federal and state privacy laws, and Cosette’s Code of Conduct and compliance policies.

Consistent with the OIG’s 2003 Compliance Program Guidance for Pharmaceutical Manufacturers and the OIG’s 2023 General Compliance Program Guidance, the Director will operationalize an effective program built around the seven elements, scaled appropriately for Cosette’s size, business model, and risk profile.

• Compliance program leadership. Under the direction of the GC/Compliance Officer, lead day‑to‑day execution and continuous improvement of Cosette’s enterprise compliance program, including the Code of Conduct, Compliance Policy, MLR SOP, HCP Interactions SOP, Drug Price Transparency Reporting Policy, AI Usage Policy, and related SOPs.
• Compliance Committee. Support the GC/Compliance Officer in convening the Compliance Committee—develop the agenda, document deliberations, and prepare reports to the CEO and the Audit Committee on program effectiveness, risks identified, and remediation status at the cadence directed by the GC/CO.
• Policy development and maintenance. Own a documented policy lifecycle (version control, periodic review cadence, named owners, change log) and ensure consistent defined terms and cross‑references across the policy suite.
• Risk assessment, auditing, and monitoring. Conduct an annual enterprise compliance risk assessment; build and execute a risk‑based monitoring and auditing workplan; document findings, corrective actions, and effectiveness verification.
• HCP interactions and fraud‑and‑abuse compliance. Oversee compliance with the Federal Anti‑Kickback Statute, False Claims Act, and applicable OIG guidance—including the 2020 Special Fraud Alert on speaker programs—governing interactions with healthcare professionals, including:
  • Fair‑market‑value (FMV) framework, written agreements, needs assessments, and caps for speaker and consultant engagements;
  • Transfer‑of‑value pre‑approval routed through Compliance (not through commercial leadership);
  • Meal, travel, and hospitality limits aligned to internal caps and the strictest applicable state requirements;
  • State gift‑ban and aggregate‑spend laws (e.g., California, Connecticut, Massachusetts, Minnesota, Nevada, Vermont).
• Federal Sunshine Act / Open Payments. Own the end‑to‑end Open Payments process for all covered recipients—annual data collection, validation, dispute resolution, CMS submission, and recordkeeping—and own state aggregate‑spend filings.
• Government pricing, drug price transparency, and 340B. Partner with Finance and Commercial on…