Manager, Corporate Compliance

BioMarin Pharmaceutical Inc.

San Rafael (CA)

Vor Ort

USD 110.000 - 150.000

Vollzeit

14 Tage+

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Zusammenfassung

BioMarin Pharmaceutical Inc. is seeking a Manager, Corporate Compliance to be a strategic compliance partner within our US Commercial and Medical organizations. This role entails providing practical guidance aligned with healthcare laws and internal policies.

The ideal candidate should possess 6-10 years of compliance experience in pharmaceutical or biotech sectors, complemented by a Bachelor's degree. They will support various compliance initiatives while fostering strong collaboration across teams.

Qualifikationen

  • 6-10 years of experience in pharmaceutical/biotech/healthcare compliance.
  • Experience in-house, at a law firm, consulting firm, or regulatory agency.
  • Familiarity with Commercial and/or Medical Affairs activities.

Aufgaben

  • Serve as a compliance advisor providing actionable guidance.
  • Design and deliver targeted compliance training.
  • Support and participate in monitoring business activities.
  • Contribute to compliance program development and maintenance.

Kenntnisse

Strong business partnering skills
Excellent communication skills
Strong collaboration skills
Organizational and project management skills

Ausbildung

Bachelor’s degree

Jobbeschreibung

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world‑class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

Role Overview

The Manager, Corporate Compliance serves as a strategic compliance business partner to BioMarin’s US Commercial and Medical organizations. This role is responsible for providing practical, risk-based guidance on business activities, ensuring alignment with applicable healthcare laws, regulations, and internal policies.

This individual will play a critical role in shaping compliant business practices, educating stakeholders on compliance guardrails, and monitoring field activities to promote both adherence and sustained understanding.

The ideal candidate is curious, proactive, and able to work independently, while building strong, trusted relationships across functions. They bring sound judgment, strong communication skills, and a collaborative, solutions‑oriented mindset.

Key Responsibilities
Compliance Business Partnership & Advisor
  • Serve as a compliance advisor to Commercial and Medical teams, providing clear, actionable guidance on business activities, engagements, and strategies
  • Interpret and apply healthcare laws, regulations, and industry codes (e.g., FDA, OIG, PhRMA) in a practical, business‑relevant manner
  • Provide risk‑based recommendations on proposed initiatives, including field activities, patient programs, advisory boards, and HCP engagements
  • Draft clear and concise legal/compliance analyses and guidance memoranda tailored to business stakeholders
  • Proactively identify compliance risks and partner with stakeholders to develop pragmatic mitigation strategies
Training, Education & Enablement
  • Partner with internal stakeholders to design and deliver targeted compliance training aligned to evolving business needs and risk areas
  • Translate complex regulations into simple, actionable guidance to drive understanding and adoption
  • Reinforce compliance expectations through ongoing education, coaching, and real‑time guidance
  • Support development and maintenance of policies, procedures, and tools that enable compliant decision‑making in the field
Monitoring & Oversight of Business Activities
  • Support and participate in monitoring of field and business activities, including patient events, advisory boards, speaker programs, and hub interactions
  • Conduct live and/or retrospective monitoring to assess adherence to compliance guardrails and identify trends or gaps
  • Partner with Commercial, Medical, and Compliance leadership to ensure appropriate follow‑up, training, and remediation based on monitoring outcomes
  • Support execution and continuous improvement of the Corporate Compliance monitoring program, including dashboard tracking and reporting
  • Drive data‑driven compliance monitoring by harnessing enterprise data and AI capabilities to generate actionable insights, detect emerging risks, and enhance the effectiveness of the monitoring program
Compliance Program Support
  • Support the ongoing development, implementation, and maintenance of the US Corporate Compliance program
  • Contribute to policy development and updates, ensuring alignment with regulatory requirements and business practices
  • Maintain current knowledge of healthcare compliance laws, enforcement trends, and industry expectations
  • Support cross‑functional initiatives and coordinate compliance‑related projects, including work with external advisors as needed
Qualifications
Education
  • Bachelor’s degree required
Experience
  • 6‑10 years of experience in pharmaceutical/biotech/healthcare compliance, legal, or regulatory roles
  • Experience in‑house, at a law firm, consulting firm, or regulatory agency preferred
  • Familiarity with Commercial and/or Medical Affairs activities required
Key Capabilities & Assets
  • Ability to work independently, manage ambiguity, and proactively identify issues and solutions
  • Strong business partnering skills with the ability to influence without authority
  • Demonstrated sound judgment and risk‑based decision‑making
  • Excellent communication skills, with the ability to translate complex requirements into clear guidance
  • Strong collaboration skills and a positive, professional presence; ability to build trust and credibility
  • High level of curiosity, initiative, and continuous learning
  • Strong organizational and project management skills
  • Proven ability to operate effectively in complex, matrixed environments
What Will Make Someone Successful in This Role
  • Is seen by the business as a trusted, practical advisor — not just a policy enforcer
  • Balances compliance rigor with business enablement
  • Takes initiative and works independently without needing constant direction
  • Communicates clearly and constructively, even in complex or sensitive situations
  • Builds strong relationships and is collaborative, approachable, and easy to work with
  • Demonstrates intellectual curiosity and continuous improvement mindset

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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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