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Compliance Associate I / II

Location San Rafael, California Workstyle Open to Hybrid
Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

SUMMARY

The primary purpose of the Associate I/II – Corporate Compliance position is to support the Senior Director – NORAM Corporate Compliance by running, on a day-to-day basis, two important functions performed by Corporate Compliance: (1) administering BioMarin’s eGrants tool and related systems and processes to perform intake, review, and disposition of grant applications received by BioMarin; and (2) managing the submission of advertising and promotional materials to the Food & Drug Administration (FDA). The successful candidate may also be asked to provide general support to the NORAM Corporate Compliance team, including organizing NORAM team meetings and global Corporate Compliance calls.

RESPONSIBILITIES

  • eGrants Program Administration
  • Manage the Corporate Compliance process for intaking, reviewing, approving, paying, and reconciling grant applications received by BioMarin by:
  • Acting as the system administrator of the eGrants tool and the subject matter expert on BioMarin’s grants policies;
  • Performing intake of incoming grant applications and ensuring compliance with BioMarin policy;
  • Facilitating review of grant applications by a cross-functional review committee;
  • Tracking and maintaining appropriate records relating to all applications;
  • Generate Letters of Agreement (LOAs) for approved applications; and
  • Facilitating payment.
  • Run weekly calls with the eGrants system vendor to track any issues and manage upgrades.
  • Train new internal BioMarin reviewers on the system.
  • Assist the Senior Director in generating insights from grants data and presenting metrics and updates to upper management.

OPDP Ad Prom Submission Administration

  • In conjunction with internal stakeholders, assist with the NORAM Corporate Compliance process for submitting advertising and promotional documents to the FDA.
  • Attend calls with Marketing and Regulatory stakeholders to discuss how the process is working and potential improvements.

General Compliance Program Support

  • Support the development, implementation, and administration of NORAM Corporate Compliance team programs within the Global Compliance & Ethics department, including support of key compliance workstreams (e.g., due diligence checks or policy revisions).
  • Support the team with additional office management tasks, including organizing NORAM team meetings and global Corporate Compliance calls.

EXPERIENCE AND SKILLS

  • Strong customer service, communication, 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 Outlook, 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.
  • Experience with iEnvision (or a comparable eGrants tool) would be a plus.
  • Experience with Veeva PromoMats would be a plus.
  • A love of compliance and enthusiasm about Corporate 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.


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.

About our location

San Rafael

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Our Benefits

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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