The purpose of the Associate Director, Corporate Compliance is to assist the Chief 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 Program (“GCP”).

RESPONSIBILITIES

List the major responsibilities of the job.

• Support the development, implementation, and maintenance of GCP activities, including counseling and training on compliance policies, anti-bribery/anti-corruption laws, advertising and promotional laws and other 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.

• Counsel internal brand teams regarding the aforementioned compliance rules and regulations, MHLW guidance documents, and industry codes (e.g. the Japan Pharmaceutical Manufacturers Association (JPMA), the Fair Trade Council (FTC) of the Ethical Pharmaceutical Drugs Marketing Industry) 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 MHLW /FTC enforcement activities.

• 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 trainings to business units as needed.

• Work with internal functional areas to provide advice and counsel, 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, as well as development and maintenance of GCP recordkeeping and metrics tracking systems.

• Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.

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

EDUCATION

State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.

A Bachelor’s degree in laws or JD is required. 

EXPERIENCE

State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

• 5+ years of experience practicing law or working in the pharmaceutical/healthcare compliance field. In-house experience at a pharmaceutical/biotechnology organization or regulatory agency strongly preferred. Major law firm experience a plus.

• 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 local laws, regulations, and industry codes.

• 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, JPMA and other industry guidance documents, MHLW regulations on the promotion of marketed products, clinical trial regulations, and issues arising under the Fair Competition Code for the Pharmaceutical Manufacturing and Sales Industry and loc as well as local laws and regulations.

• Demonstrated effectiveness operating in complex organizational and regulatory environments.

• Excellent written, oral, and presentation skills and fluent in English. 

• 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.

WORK ENVIRONMENT / PHYSICAL DEMANDS

Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.

Must be willing to travel, including internationally, as necessary.

EQUIPMENT

Describe any equipment required to perform the job.

Laptop and cell phone.