Compliance Attorney

Location:  San Rafael, California Category: Legal / Government Affairs Employment Category: Fulltime-Temporary

Description

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.
 
 

Duties


The purpose of the Compliance Counsel, Global Compliance & Ethics position is to assist the Vice President, Deputy Compliance Officer 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 & Ethics Program (“GCEP”). Specifically, the Director will support the Anti-Bribery Anti-Corruption (“ABAC”) Program and Investigations.


 



    • Support the development, implementation, and maintenance of GCEP activities relating to the ABAC Program, including maintenance and development of ABAC procedures, and support of cross-regional GCE partners to ensure business activities comport with global healthcare compliance regulations.


 



    • Assist with regulatory intelligence efforts regarding global ABAC laws, including drafting memorandum regarding statutory developments and performing an impact assessment.


 



    • Support the global ABAC program development, including:


 



    • FMV Program – Support workable, business-oriented solutions for achieving fair market value in payments to HCPs and patient/PAG stakeholders worldwide.

    • Due Diligence – Assist with vetting of partners and consultants, leveraging external background check resources as well as internal systems, and ensure systematic escalation and vetting of “red flags.”

    • Monitoring and Healthcare Audits – Execute on ABAC data monitoring, healthcare audits and assessments, and response protocols are in place to respond to developing risks.

    • Training – assist with development of training materials.

    • Database and Dashboard maintenance – assist with design and development of dashboard representing all ABAC workstreams.

    • Dawn Raid Policy/Process and Training – assist training program owner to ensure regional GCE and business personnel are briefed, trained, and prepared for dawn raid scenarios.


 



    • Support regional GCE personnel in establishing regional monitoring/audit plans.


 



    • Assist the VP, Deputy Compliance Officer in managing cross-regional coordination and communication – provide centralized GCE support to business stakeholders undertaking global (cross-regional) activities, and support analysis of regional GCE activities and controls.


 



    • Assist with development and implementation of corrective action plans where compliance violations have been established.


 


 


Coordinate project management of various GCEP related activities and requirements, including management and coordination of outside consultants.


 

Skills




    • Experience with and/or understanding of compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally. Experience with FCPA and/or ABAC matters or programs a plus.


 



    • Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in OIG Guidance and the Federal  Sentencing Guidelines.


 



    • Excellent written, oral, and presentation skills. 


 



    • Motivated, self-starter and team player with ability to appropriately prioritize issues and allocate resources.


 


Positive attitude and sense of humor are critical

 

Education


A Bachelor’s degree and JD are required.

 
 
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.