Senior Manager, Compliance Counsel, Global Compliance and Ethics
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
Role and Responsibilities
- Supporting the development, implementation, and maintenance of Global Compliance & Ethics Program (GCE) activities, including counseling and training on compliance policies and healthcare compliance regulations.
- Support of GCE regulatory intelligence efforts, including analysis of FDA and OIG guidance documents, emerging state and federal regulations, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations
- Draft memorandum's providing legal analysis and risk-based recommendations regarding the compliance rules and regulations (e.g., advertising & promotion, fraud & abuse, anti-kickback, privacy, and false claims act statutes) implicated by proposed or existing business strategies.
- Review and analysis of advertising and promotional initiatives, pipeline products/clinical trial recruitment materials, market access, grants/donations and sponsorship's, and related research on FDA/OIG enforcement activities.
- Assist with investigation of alleged violations of compliance policies, laws, regulations, or procedures and development of corrective action plans where compliance violations have been established.
- Provide analysis, guidance, and support to (1) Market Access and distribution functions, including review and analysis of payer communications; (2) Patient Services functions, including review and analysis of patient services hub activities and patient assistance programs (e.g., copay cards and free drug programs); and (3) Commercial management regarding the structure and execution of field-based roles.
- Assist with Corporate Funding and Support Program, including review of NORAM applications for charitable contributions, educational grants and sponsorships.
- Assist with creation of training plan and training modules in connection with compliance policies, including but not limited to: new hire orientation, anti-bribery and anti-corruption program, privacy, and promotional regulations. Present training's to business units as needed.
- 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.
- Assist with coordination and management of healthcare auditing and monitoring program.
- Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
A JD degree preferred.
- 2 - 4 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.
- 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, sound business judgment, and a sense of humor.
- 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, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.