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Associate Director, Compliance, Investigations & Monitoring

🔥 0 minutes ago

🍂 Massachusetts – Remote

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💵 $170k - $210k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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👻 Ghost score 2%

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Logo of Galderma

Galderma

5001 - 10000 employees

Founded 1981

🏥 Healthcare

💼 Consulting

💄 Beauty

Healthcare • Consulting • Beauty

Galderma is a global company that focuses on dermatology, offering a diverse range of products and services across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. With a strong emphasis on innovation, Galderma develops and delivers cutting-edge, premium brands tailored to individual skin needs. The company's mission is to advance dermatology for every skin story, acknowledging the unique nature of every individual's skin. Galderma operates with a global presence and engages in partnerships to bring its dermatological innovations to life while also being committed to sustainability and governance oversight.

📋 Description

• Lead the U.S. Compliance Investigations program and oversee its day-to-day operation • Own the investigations program framework and coordinate with HR, Legal, Compliance Business Partners, and other stakeholders • Establish intake, triage, scoping, documentation, and closure standards • Conduct investigations, including data review, interviews, and evidence assessment • Lead investigation readouts with senior leadership • Recommend remediation and independently handle matters of varied complexity • Interpret policies and implement remediation such as policy updates, training, coaching, and enhanced monitoring • Develop investigations procedures, documentation, templates, guidance, and training • Train cross-functional colleagues on investigations processes, documentation, and case management expectations • Design and continuously improve the U.S. compliance monitoring program • Build and execute risk-based monitoring plans covering field rides, speaker programs, advisory boards, trainings, congresses, and in-market promotional or educational events • Refine monitoring methodologies and sampling • Identify emerging risks, anomalies, and trends for transactional and data-driven monitoring and analytics • Develop dashboards and reporting packages • Deliver periodic monitoring reports to leadership and committees • Support targeted reviews and promote a strong ethics and compliance culture • Collaborate across teams through virtual and in-person meetings

🎯 Requirements

• Juris Doctor (JD) or in-house compliance investigations experience at a pharmaceutical or medical device company • 8-12 years of experience advising a pharmaceutical, biotechnology, or life sciences company on compliance matters • Significant experience conducting internal compliance investigations and managing investigations programs • Expertise and significant experience advising on U.S. healthcare compliance for prescription products and devices • Deep knowledge of pharmaceutical industry regulations and therapeutic areas • Knowledge of the Federal Anti-Kickback Statute, False Claims Act, FDCA, OIG/DOJ guidance, PhRMA Code, U.S. state and local marketing compliance laws, and relevant enforcement actions • Experience designing and executing monitoring programs, including field-based monitoring and data-driven analytics • Strong commercial acumen and understanding of market dynamics and business culture impacts • Excellent analytical and critical thinking skills, including large datasets, trend identification, and big-picture analysis • Strong interpersonal, communication, and influencing skills • Ability to work effectively with senior leadership and stakeholders at all levels • Ability to manage multiple complex matters in a fast-paced environment • Strong project management and organizational skills • Ability to handle confidential information appropriately and exercise sound judgment on sensitive investigations and monitoring matters • Demonstrated commitment to compliance, ethics, and accountability • Ability to travel up to 30% • Must be eligible to work in the United States • This role does not offer sponsorship for work authorization

🏖️ Benefits

• Annual short-term incentive program, subject to plan terms and eligibility requirements • Medical, dental, and vision coverage • 401(k) plan with employer match • Paid time off • Competitive compensation • Comprehensive benefits • Opportunities for growth, development, and collaboration • Inclusive and innovative work environment • Reasonable accommodations for individuals with disabilities

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