Job description
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
Job Description
Location: Onsite with Flexibility
Essential Functions
- Partner with multiple Business Units and assist in the implementation of initiatives to ensure compliance with the company’s compliance manuals, OIG Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code, the Food Drug and Cosmetic Act (FDA), the Physician Payments Sunshine Act, and other state and federal laws and regulations.
- Work closely with the Head of U.S. Compliance to resolve highly complex ethics and compliance matters and identify compliance risks
- Work closely with the Head of U.S. Compliance and other U.S. Compliance team members on rolling out, driving and adopting global campaigns and initiatives within the U.S. Region
- Serve as an integral participant in the U.S. Global Risk Compliance Council 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
- Oversee selected aspects of the management of outside counsel and various vendors tasked with supporting the U.S. Compliance department
- Stay informed of changes in applicable rules, regulations, standards and related trends and advise senior leadership of these changes
- Review and draft policies and standard operating procedures
- Lead compliance training throughout the company along with support from the Global Compliance organization
- Work collaboratively with the Legal and HR Departments in conducting or directing the internal investigation of compliance issues to include investigation, follow-up, and resolution activities and solutions
- Assist in follow-through for concerns raised by the Global Compliance Integrity Line, known as Speak Up
- Other duties as assigned
Minimum Education, Knowledge, Skills, and Abilities
- Bachelor’s Degree required
- JD (or international equivalent) preferred
- Eight (8) or more years of legal or compliance experience with strong knowledge and understanding of U.S. healthcare compliance and broader legal and regulatory framework highly desired
- Previous experience with a pharmaceutical, medical device, or biotech company or within a law firm environment working on compliance issues is preferred, though willing to consider exceptional candidates without this experience
- Experience in a heavily regulated industry is required, and experience with regulations applicable to the pharmaceutical and medical device industries ideal
- 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 situations
- 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
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