Director, Compliance Counsel, Global Compliance and EthicsLocation San Rafael, California Workstyle Hybrid Apply
It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin.
Role and Responsibilities
- Brand lawyer supporting marketed and pipeline products: Counsel internal brand teams regarding advertising and promotion, sales and marketing initiatives, compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals, payors, patients, and/or patient advocacy organizations.
- Review and analysis of advertising and promotional initiatives, pipeline product activities, and medical materials related to a particular product/disease area.
- Provide analysis, guidance, training, and support to functions engaged in external communications and outreach such as Marketing, Sales, Market Access, Patient Advocacy, Medical Affairs, and Corporate Communications.
- Support the development, implementation, and maintenance of Global Compliance & Ethics Program (GCP) activities, including counseling and training on compliance policies and healthcare compliance regulations.
- Draft memoranda providing legal analysis and risk-based recommendations regarding Ad Promo and compliance rules and regulations (e.g., fraud & abuse, anti-kickback, , and false claims act statutes) implicated by proposed business strategies.
- Assist with periodic compliance risk assessments and investigations of alleged violations of compliance policies, laws, regulations, or procedures and development and implementation of corrective action plans where compliance violations have been established.
- Prepare regular briefing documents to keep Executive Management up-to-date on latest industry events and trends including OIG and FDA enforcement statistics, CIA trends, global enforcement trends, and analysis of OPRP/DDMAC warning and untitled letters.
- Work with internal functional areas to provide advice and counsel; identify, analyze, and mitigate risks, ensure appropriate/adequate training, and support adherence to policies/procedures relating to compliance matters.
- Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
A JD degree.
- 6 - 10 years of experience working in a law firm or the pharmaceutical/healthcare legal/compliance field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
- Experience with pipeline and marketed brand support and associated statutes, regulations, guidance documents, enforcement trends, and best practices related to the pharmaceutical, biotechnology, and/or healthcare industry generally.
- Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
- Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
- Demonstrated effectiveness operating in complex organizational and regulatory environments.
- Excellent written, oral, and presentation skills.
- Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
- Strong problem solving, risk analysis, and project management skills.
- Demonstrated ability to partner effectively with others in addressing complex issues.
- Strong persuasive skills and sound business judgment.
- Motivated, self-starter with ability to appropriately prioritize issues, drive projects, and allocate resources.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
In the U.S., the salary range for this position is $ 188,000 to $ 282,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.