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Senior Manager, Corporate Compliance

Job in San Rafael, Marin County, California, 94911, USA
Listing for: Initial Therapeutics, Inc.
Full Time position
Listed on 2026-08-22
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 140000 - 210000 USD Yearly USD 140000.00 210000.00 YEAR
Job Description & How to Apply Below

Role Overview

The Senior Manager, Corporate Compliance serves as a strategic compliance business partner to Bio Marin’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.
  • J.D. preferred.
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 & Attributes
  • 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…
Position Requirements
10+ Years work experience
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