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Corporate Compliance Counsel

Employer
BioMarin Pharmaceutical Inc.
Location
San Rafael, California
Start date
Nov 19, 2021

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

Job Details

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.


The purpose of the Temp Compliance Counsel position is to assist the Executive Director, Global Compliance & Ethics in implementing, updating, monitoring, and enforcing the compliance policies and processes of BioMarin Pharmaceutical Inc. and its subsidiaries’ (collectively referred to as “BioMarin”) as part of the Global Compliance Program

    • Support the development, implementation, and maintenance of GCP activities, including counseling and training on compliance policies, advertising/promotion and anti-bribery/anti-corruption laws, healthcare compliance regulations, privacy, and transparency/aggregate spend regulatory requirements.
    • Draft memoranda 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.
    • Assist the Executive Director in counseling internal brand teams 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.
    • Assist with the review and analysis of advertising and promotional initiatives, pipeline products/clinical trial recruitment materials, grants/donations and sponsorships, government price reporting and related research on FDA/OIG enforcement activities.
    • Work with internal functional areas to provide advice and counsel, ensure appropriate/adequate training, engage in monitoring, and support adherence to policies/procedures relating to compliance matters
    • Assist with memorializing and communicating regulatory intelligence regarding new enforcement and emerging laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
Skills
    • Minimum of 3  years of experience practicing law or working in the pharmaceutical/healthcare compliance field.
    • 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 persuasive skills and sound business judgment.
    • Motivated, self-starter with ability to appropriately prioritize issues and allocate resources.
Education

A bachelor's and JD are required


 
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.

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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