Director, Compliance

Director, Compliance

Cosette Pharmaceuticals, Inc. is a US-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. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

Innovating every day.™

Position Summary

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) and 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.

Key Responsibilities

• 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 Medicaid, FSS/DAPA, 340B, and state Drug Price Transparency reporting; ensure written methodologies, validated data, and on-time submissions, and oversee vendor performance (e.g., Two Labs) including QC, audit rights, and a per-state filing calendar.
• MLR / advertising and promotion. Serve as the standing Compliance member of the Medical, Legal, and Regulatory review committee; ensure promotional and non-promotional materials are reviewed for AKS, OIG, FDA, and FTC compliance; ensure mandatory re-review of materials on labeling/safety updates and a defined withdrawal/recall procedure.
• PDMA sample accountability. Establish and own the PDMA sample-handling program (21 C.F.R. Part 203) — distribution, storage, recordkeeping, reconciliation, and loss reporting — for any Cosette samples distributed to HCPs.
• Exclusion and debarment screening. Stand up and maintain monthly screening of employees, contractors, vendors, HCPs, and speakers against the OIG LEIE, GSA/SAM, and FDA Debarment List (21 U.S.C. § 335a), with documented evidence and clear remediation procedures.
• Training. Design and deliver risk-based compliance training (including new-hire, annual refresher, role-specific, and ad-hoc training following significant events or policy changes); track completion and effectiveness; capture signed acknowledgements.
• Investigations. Lead investigations of compliance allegations, coordinate with Legal, HR, and outside counsel as appropriate, document root cause and corrective action, and ensure consistent, well-publicized disciplinary standards.
• Reporting channels and non-retaliation. Own the company's anonymous hotline and other reporting channels, ensure non-retaliation is operationalized, and track and analyze report trends.
• Privacy, AI, and data governance. Partner with IT and Legal on HIPAA (where applicable), state privacy laws (e.g., CCPA/CPRA), GDPR (as relevant), AI governance, and adverse-event / product-complaint capture procedures relating to AI tools.
• State and federal compliance program obligations. Maintain Cosette's compliance with state comprehensive compliance program statutes (e.g., California Health & Safety Code §§ 119400–119402), including annual written declarations of compliance and any state-required summaries.
• Anti-corruption (FCPA). Maintain and enforce an anti-bribery/anti-corruption program covering foreign officials and third-party intermediaries, with due-diligence and approval workflows for international CMOs, sourcing, and distributors.
• Government inquiries and enforcement matters. Serve as a primary point of contact for FDA, OIG, DOJ, CMS, and state regulators on compliance matters; coordinate response strategy with Legal and outside counsel.
• Culture and ethics. Promote a "speak-up" culture that supports Cosette's values and the highest standards of ethical conduct across all functions.

Qualifications

Required:

• Juris Doctor (J.D.) from an ABA-accredited law school and active bar membership in at least one U.S. jurisdiction, NJ preferred.
• Minimum eight (8) years of progressive healthcare-compliance experience in the pharmaceutical, biotechnology, or medical-device industry, including at least three (3) years in a leadership or program-ownership role.
• Demonstrated working knowledge of the U.S. Federal Anti-Kickback Statute, False Claims Act, Federal Food, Drug, and Cosmetic Act, OIG Compliance Program Guidance for Pharmaceutical Manufacturers (2003) and General Compliance Program Guidance (2023), Physician Payments Sunshine Act, PhRMA Code, PDMA, Medicaid Drug Rebate Statute, 340B, and applicable state pricing-transparency and gift-ban laws.
• Track record building and operating compliance program elements (risk assessment, monitoring, training, investigations, hotline, exclusion screening, transparency reporting).
• Sound judgment, demonstrated ability to influence senior leadership, and the integrity to raise concerns through Cosette's chain of escalation (the GC/Compliance Officer, the CEO, and, where appropriate, the Audit Committee).

Preferred :

• Certified in Healthcare Compliance (CHC) or Compliance Certification Board (CCB) certification.
• Prior commercial-launch experience and direct MLR committee experience.
• Experience scaling a compliance program at a small-to-mid-size manufacturer.
• Familiarity with contract manufacturing (CMO) relationships and FCPA program design.

Knowledge, Skills, and Abilities

• Strong written and verbal communication skills, including