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Sr. Manager, Compliance Counsel

Employer
BioMarin Pharmaceutical Inc.
Location
San Rafael, California
Start date
Mar 29, 2024

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

Who We Are

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.      

Sr. Manager, Compliance Counsel   Role and Responsibilities   General Compliance Program Support   
  • Support the development, implementation, and maintenance of the Global Corporate Compliance activities focusing on developing, updating and counseling on U.S. compliance policies, anti-bribery / anti-corruption laws, and healthcare compliance regulations as well as conducting internal compliance investigations.
  • Support of US Corporate Compliance regulatory intelligence efforts, including application of new and existing FDA and OIG guidance documents, emerging state and federal regulations, and industry codes (e.g. PhRMA) to current policies as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations.
  • Draft memoranda providing legal analysis and risk-based recommendations regarding the compliance rules and regulations (e.g., fraud & abuse, advertising and promotion, anti-kickback, and false claims act statutes) implicated by proposed or existing business strategies.
  • Counsel internal stakeholders regarding the aforementioned 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 and/or patients or patient advocacy organizations.
  • Work with internal functional areas to develop and deploy 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.
  • Coordinate project management of various Corporate Compliance related activities and requirements, including management and coordination of outside consultants.
   Internal Investigations Support   
  • Provide support to Sr. Director, Compliance Counsel on all Internal Investigations of alleged violations of compliance policies, laws, regulations, or procedures. 
  • Develop and implement corrective action plans where compliance violations have been established and track completion of corrective action activities.
  • Support and participate in Internal Investigations Governance Committee.
  • Support management of all records and executive read-outs related to Internal Investigations.
   Education   A bachelor’s degree and JD are required as well as admittance to and good standing with a state bar.     Experience   
  • 4-6 years of experience working in the pharmaceutical/healthcare legal/compliance/internal audit field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
  • Experience with and/or understanding of compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally.
  • Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
  • Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, FDA regulations on the promotion of marketed products, 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 problem solving, risk analysis, and project management skills.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.     

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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