Senior 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 Senior Director, Compliance leads the design, implementation, oversight, and continuous improvement of Cosette Pharmaceuticals’ enterprise compliance program under the direction of Cosette’s General Counsel & Compliance Officer (“GC/CO”). The Senior Director serves as the senior leader for compliance operations, applies compliance expertise and business judgment to strengthen policies and controls, establishes risk-based priorities aligned with business needs, and provides actionable recommendations based on program trends and emerging risks. The role partners closely with the GC/CO on Compliance Committee operations and reporting to the CEO and the Audit Committee and oversees operational compliance with U.S. healthcare fraud and abuse laws, FDA advertising and promotion requirements, federal and state drug-price transparency and aggregate-spend obligations, the Prescription Drug Marketing Act (PDMA), exclusion and 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 Senior Director oversees an effective program built around the seven elements and tailored to Cosette’s size, business model, evolving risks, and business needs.

Key Responsibilities

• Compliance program leadership. Under the direction of the GC/Compliance Officer, provide strategic leadership & oversight to Cosette’s enterprise compliance program, including day-to-day execution and continuous improvement initiatives, 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 and continuously improve the documented policy lifecycle (version control, periodic review cadence, named owners, and change log); apply senior-level compliance expertise and business judgment to proactively identify policy needs, develop and update policies in response to evolving regulatory and business requirements, streamline and harmonize the policy suite, and ensure consistent defined terms and cross-references.
• Risk assessment, auditing, and monitoring. Lead the enterprise compliance risk-management strategy, including the annual 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. Set and oversee compliance training priorities based on business needs, role-specific risks, and regulatory developments; oversee new-hire, annual, and targeted training; and evaluate effectiveness and follow-up needs.
• 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, analyze reporting trends and emerging risks, and develop actionable recommendations and remediation plans to strengthen controls, address root causes, and drive continuous program improvement.
• 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.
• 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 member ship in at least one U.S. jurisdiction, NJ preferred.
• Minimum ten (10) years of progressive healthcare-compliance experience in the pharmaceutical, biotechnology, or medical-device industry.
• 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.

Knowledge, Skills, and Abilities

• Strong written and verbal communication skills, including the ability to translate complex regulatory requirements into clear, practical guidance for business teams.
• Excellent analytical, organizational, and project-management skills; able to manage competing priorities under deadline.
• Demonstrated independence and integrity; comfortable raising hard issues constructively.
• Proficiency with compliance technology (training, monitoring, screening, aggregate-spend, contract lifecycle) and Microsoft 365.
• Ability to work cross-functionally with Legal, Regulatory, Quality, Medical Affairs, Commercial, Finance, IT, and HR.

Working Conditions and Travel

Office-based with hybrid flexibility. Periodic domestic travel (estimated 15–25%) for site visits, audits, training, industry events, and meetings with Cosette’s manufacturing and commercial partners. Occasional international travel may be required to visit CMOs or international affiliates.

Salary Range

The expected annual base salary for this New Jersey based position is $225,000 - $281,000. In addition, you may be eligible for a discretionary bonus if you are an active employee on the payment date.

Benefits

Hired applicants will be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health saving account, employee assistance program, tuition reimbursement program, parental leave, wellness program, paid time off, volunteer time, and holidays.

Physical Requirements

This role will follow a hybrid work schedule, requiring three (3) onsite days per week at our Bridgewater, NJ office.

Equal Opportunity Employment

Cosette Pharmaceuticals, Inc. is committed to providing equal employment opportunity to all applicants and employees in all phases of our operations. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual’s race, creed, religion, color, national origin, citizenship, ancestry, age, sex, pregnancy, childbirth or related medical conditions, gender identity or expression, sexual orientation, marital status, domestic partnership, familial status, reproductive health decisions, status as a victim of domestic violence, stalking, or sexual assault, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, veteran status, liability for service in the United States armed forces, or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.