Description:

The Corporate Counsel, Commercial & Compliance will report to the Assistant General Counsel and will be responsible for providing legal support of the Company’s commercial affairs and operations, as well as the Company’s healthcare compliance program and initiatives. The Corporate Counsel, Commercial & Compliance will be responsible for drafting and advising on company agreements, implementing and managing healthcare compliance and ethics policies and related training, and advising at various stages of domestic and international product commercialization and marketing.

You’re Awesome At:
Supports the Company’s commercial operations by:
  • Providing legal and business advice and drafting expertise for a broad range of commercial and operational agreements, including non-disclosure, material transfer, supply, manufacturing, equipment, software, leases, distribution, clinical trial, pump training, and provider agreements with health insurance payors and administrators.
  • Working closely with regulatory, sales and marketing groups to review patient and HCP-facing marketing and promotional materials for projects and events.
  • Ensuring Company maintains all applicable state licenses and complies with applicable state licensing requirements.
  • Assisting with resolution of customer complaints and management of product liability litigation.
  • Supporting emergent commercial legal matters on an as-needed basis.

Supports the Company’s compliance initiatives by:
  • Drafting, maintaining, and revising compliance policies and procedures.
  • Preparing and delivering compliance trainings to mitigate compliance risks.
  • Identifying emerging industry and Company trends and risks and modifying compliance training program as needed.
  • Preparing effective communications to internal audiences to foster culture of compliance.
  • Responding to compliance questions, concerns, and complaints from individuals throughout the organization, as well as external sources.
  • As directed, facilitating third party audits, and conducting internal compliance audits to ensure global adherence to legal and compliance policies and procedures.
  • Reviewing requests for third party events, HCP arrangements, grants, charitable donations, and similar matters for compliance with laws and internal policies.
  • Identifying, recommending, and implementing internal controls for appropriate approvals of new contractual commitments to further compliance program objectives and manage risk.
  • Consulting as needed with peers in regulatory, finance, quality, and other departments to ensure compliance with laws and regulations impacting specific company functions.
  • Conducting compliance investigations.
  • Communicates effectively and keeps supervisor informed of activities and significant issues.
  • Functions independently and delivers results with minimum supervision.
  • Maintains the confidentiality of Legal Department communications and documentation.
  • Special projects and other responsibilities as assigned.
  • Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

Extra Awesome:
  • Law degree (JD or equivalent) with excellent academic credentials and a license to practice in the state of California, or licensed in another state and registered as In-House Counsel in California.
  • 5+ years of relevant legal experience with complex commercial transactions, preferably including at least 1 year of in-house experience with a medical device, pharmaceutical or biotech company.
  • In-depth understanding of the federal False Claims Act, Anti-Kickback Statute, and Food Drug and Cosmetic Act.
  • Working understanding of international, federal, and state rules and regulations applicable to medical device companies.
  • Experience with and breadth of knowledge related to contract law.
  • Working understanding of clinical trials and related laws, regulations, and agreements.
  • Strong verbal and written communication skills.
  • Ability to operate independently and prioritize effectively while handling substantial and diverse work volume and serving as a key contributor for a rapidly growing organization.
  • High level of integrity supported by sound judgment and ethics.
  • Familiarity with subject matter relevant for key areas of responsibilities.
  • Effective interpersonal skills and presentation styles to interact with diverse audiences, including outside attorneys, senior management, and business associates.
  • Expertise in counseling clients on best practices for commercial, compliance, clinical trial and supply chain functions.