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Associate Director, Corporate Counsel, Product & Commercial

Employer
BioMarin Pharmaceutical Inc.
Location
San Rafael, California
Start date
Feb 22, 2024

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.

   

Associate Director, Corporate Counsel, Product and Commercial   

Role and Responsibilities      
  • Counsel internal stakeholders regarding advertising and promotion, external communications, sales and marketing initiatives, FDA and OIG guidance, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals, payors, patients, and/or patient advocacy organizations.
  • Independently draft, review, and negotiate commercial contracts to support BioMarin’s Commercial organization.
  • Provide analysis, guidance, training, and support to functions such as Marketing, Sales, Market Access, Patient Advocacy, Medical Affairs, and Corporate Communications engaged in external communications and outreach related to pipeline and/or approved products and related conditions.
  • Advise internal stakeholders on potential legal issues and appropriate risk mitigation strategies regarding advertising, promotion, product liability, anti-trust, and relevant healthcare rules and regulations (e.g., fraud and abuse, anti-kickback, and false claims act statutes).
  • Work closely with Global Compliance & Ethics Program including counseling and training on compliance policies and healthcare compliance regulations.
  • Assist with periodic compliance risk assessments and investigations of alleged violations of corporate policies and procedures, laws, or regulations, and advise on 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 related to key risk areas including OIG and FDA enforcement, CIA trends, and analysis of OPDP warning and untitled letters.
  • Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology companies, along with recent industry trends and changes.
   Education   A JD degree and active bar license  Experience   
  • 3 - 7 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 in drafting, reviewing, and negotiating commercial agreements.
  • 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.
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. 


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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