Compliance Associate I/II, Corporate Compliance

Location:  San Rafael, California Category: Compliance

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.

SUMMARY

The primary purpose of the Associate I/II – Corporate Compliance position is to assist the Director – NORAM Corporate Compliance in implementing, updating, monitoring, and enforcing BioMarin’s compliance policies and processes as part of the Company’s Global Compliance & Ethics program (the “Program”). Specifically, the Associate I/II will assist with BioMarin Grants, Anti-Bribery Anti-Corruption due diligence activities, Monitoring, Training, and Compliance Records Management.

RESPONSIBILITIES

General Compliance Program Support

  • Support the development, implementation, and administration of NORAM Corporate Compliance Team programs within the Global Compliance & Ethics Department.
  • Assist with the preparation, tracking, and record retention of all required Office of Prescription Drug Promotion (“OPDP”) 2253 submissions. Providing final review and quality control of global advertising and promotional pieces.
  • Support administration and organization of Microsoft Teams system for use by Corporate Compliance team.
  • Assist with management and organization of folder structure and access rules for Compliance documents as well as support team in uploading legacy documents to team folder structure.
  • Assist in management and tracking of version control for policies including tracking any scheduled or requested policy updates.
  • Support team with additional office management tasks including filing, binder creation, and supplies management.
Anti-Bribery, Anti-Corruption Program Support
  • Assist with due diligence of partners and consultants, leveraging external background check resources as well as internal systems, and facilitating systematic escalation and analysis of “red flags.”
  • Assist team in document management for ABAC program.
  • Attend team ABAC meetings, compiling meeting minutes and tracking any action items for follow-up. 

Monitoring and Training Program Support

  • Assist with the tracking and record retention of all Compliance training records in training management system.
  • Printing and assembling information packets for new hire orientations.
  • Assist training team with tracking and follow-up on training records including following-up with employees who are late on assigned training.
  • Assist with facilitation and ongoing maintenance of various Corporate Compliance program-related activities and requirements, including but not limited to managing documentation relating to meeting request forms (MRFs) for speaker programs, patient events, and advisory boards in Veeva system; assist with document-retention and management of approved forms and related post-event documentation.
  • Assistance with calendaring and tracking monitored events and follow up on missing documentation for events pre and post event.
Grants Program Support
  • Assist the NORAM Grants Coordinator with data migration – helping to copy over data and attachments from old grants management system into new system.
  • Assist the NORAM Grants Coordinator with ongoing management of the grants system and grant applications including review of grants inbox and responding to applicant inquiries, review of submitted applications and assessment against BioMarin policies, following up on in-process grants, and drafting funding agreements for approved grants.
Investigations Support
  • Manage and organize investigations records and generate spreadsheets and reports via hotline system.
  • Support internal investigations team in connection with document reviews and compilation of investigation reports and exhibits.

 EXPERIENCE AND SKILLS

  • Strong customer service and problem-solving skills.
  • Strong organizational skills and sound business judgment.
  • Motivated, self-starter with ability to appropriately prioritize issues and allocate resources.
  • Experience with Excel, PowerPoint and Word (and preferably Office 365).
  • Proven ability to work collaboratively in a team environment and to partner effectively with others in addressing complex issues.
  • Experience at a pharmaceutical/biotechnology organization strongly preferred.
  • A love of compliance and enthusiasm about compliance’s role in supporting the success of the business and a healthy corporate culture.
EDUCATION
  • A Bachelor’s degree is required. Will consider relevant time and experience in lieu of degree.
  • Healthcare Compliance Certification preferred, but not required.
WORK ENVIRONMENT/PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

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.