Associate Director, Compliance Business Partner

Associate Director, Compliance Business Partner

Location : Boston, MA

Position Summary

Reporting to the US Head of Ethics and Compliance, the Associate Director, Compliance Business Partner will play a critical role in managing and enhancing the compliance program for Galderma's Therapeutic Dermatology Business Unit. This position advises on compliance matters, key risk areas, and drives a strong culture of trust within the business and partner functions. As the dedicated Compliance Business Partner for the Therapeutic Business Unit, this position partners cross functionally with Medical Affairs, Marketing, Sales, Market Access, Field Reimbursement, and other functions to drive a culture of integrity and support compliant business operations in Galderma's prescription portfolio.

Essential Functions

• Business Partnership : Serve as the key strategic business partner to Galderma's Therapeutic Business Unit in the US helping leaders and their teams execute on business objectives while mitigating potential compliance-related risks.
• Lead discussions with senior leaders and help shape the organizational mindset around Galderma's values to firmly embed ethical decision making principles.
• Provide guidance on compliance with company policies as well as laws and industry guidance (e.g., OIG Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the Food Drug and Cosmetic Act (FDA), the Physician Payments Sunshine Act, and other state and federal laws and regulations).
• Compliance Program Development and Management : Lead, enhance, and operationalize elements of the U.S. Compliance Program to ensure compliance with company policy, laws, regulations, and industry guidance : draft pragmatic policies and procedures, develop and deliver engaging training sessions and communications tailored to Galderma's business, and ensure a monitoring and risk management plan appropriate for Galderma's business.
• Develop strategies in which the Ethics and Compliance team may utilize data gained through the various activities it undertakes (e.g. training, monitoring, investigations, etc.) to support the continuous evolution of program operations.
• Work closely with the Head of U.S. Compliance to resolve highly complex ethics and compliance matters and identify compliance risks
• Advise the U.S. Global Risk Compliance Council as needed and participate as an active member of the Global Legal & Compliance organization
• Monitor and audit compliance systems and provide periodic assessments and reporting based on the U.S. risk assessment and reporting obligations to the Global Risk & Compliance Committee
• Conduct field monitoring including field rides, attendance at promotional and educational events, and congresses
• Participate in the review of annual needs assessments pertaining to HCP engagement in the United States; provide tactical support for HCP engagement through the review of legitimate business needs for HCP engagement, supporting the contracting process, fair market value computation and screening process, as well as other necessary elements in order to fulfill Safe Harbor requirements under the federal Anti-Kickback Statute
• Stay informed of changes in applicable rules, regulations, standards, and related trends and serve as a resource for leadership, anticipate the impact on processes, and proactively engage with business stakeholders to determine how to partner together to address.
• Provide support for internal compliance investigations related to potential violations of policies, laws or regulations and oversee corrective actions with the business as needed, in close collaboration with Legal and HR Departments.
• Assist in follow-through for concerns raised by the Global Compliance Integrity Line, known as Speak Up
• The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Knowledge, Skills, & Abilities

Bachelor's Degree required, JD preferred The ideal candidate will have 10+ years of experience advising a pharmaceutical company on compliance matters. In house experience required, and foundational law firm experience is a plus Expertise and significant experience advising on US healthcare compliance for prescription devices, including product launches Deep knowledge of pharmaceutical industry regulations and therapeutic areas. Knowledge of the various laws, regulations, and industry guidance relevant to the commercialization of pharmaceutical products (including but not limited to Federal Anti-Kickback Statute, False Claims Act, Food Drug and Cosmetics Act, OIG and DOJ Guidelines, PhRMA Code, US state and local marketing compliance laws and relevant government enforcement actions. Appreciation for the nuances of business culture that impact business processes and compliance. Strong commercial acumen and understanding of market dynamics. Experience supporting Market Access channel strategy and accounts, payor marketing, pricing and access strategy, payor and distributor contracting from a compliance perspective Excellent verbal and written communication skills, including strong presentation skills Reputation for the highest integrity and ethical standards Excellent qualitative and quantitative analytical skills to identify and solve a wide range of business problems Ability to interact and partner effectively with senior management and associates at all levels within the organization Ability to manage multiple priorities and meet deadlines in a fast-paced work environment Ability to effectively manage conflict and other challenging situation Ability to work with cross-functional teams and engage in direct conversations across the organization Self-starter who can lead projects independently from inception to completion with minimal supervision Ability to identify potential compliance and business issues and propose solutions to management Strong attention to detail and strong organizational skills Excellent influencing and negotiating skills Experience working in a highly matrixed, global organization

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employer's Rights :

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.