Counsel (Compliance)

Overview

The organization is seeking a Counsel to join its Compliance Team within the Legal Department. This role will partner with commercial teams to provide compliance guidance and support contracting efforts, primarily for sales and EMR (electronic medical record) integration activities related to the organization’s diagnostic clonoSEQ assay offered to physicians, hospitals, and community groups.

Responsibilities

• Advise on routine, ongoing compliance queries within the diagnostic clonoSEQ business, including alignment with compliance requirements, commercial initiatives, and interactions with healthcare professionals globally.
• Provide guidance to the business and integrate compliance controls into the scope of existing business practices where applicable.
• Draft, review, and negotiate laboratory services agreements (LSAs), EMR integration agreements, and other customer-facing contractual arrangements relating to the clonoSEQ assay.
• Lead internal efforts focused on risk mitigation and compliance with government contract terms.
• Partner closely with privacy and commercial attorneys and counterparts in market access, marketing, finance, security, and operations to identify issues and evaluate and mitigate risks.
• Maintain current working knowledge of relevant laws, regulations, and industry guidance affecting the corporate-wide compliance program, including (but not limited to):
  • Antikickback and fraud and abuse laws
  • Transparency laws
  • OIG and DOJ guidelines
  • Industry standards such as the AdvaMed and MedTech codes.
• Perform other duties as assigned, including projects or workstreams outside what is expressly contemplated.

Requirements

• Juris Doctorate from a nationally accredited law school.
• Current member in good standing of a U.S. state bar.
• At least 5+ years of prior in-house or law firm experience providing compliance and/or transactional legal counsel.
• Ability to travel at least 3–5 times per year for in-person team or department meetings, audit opportunities, and other meetings as required.
• Knowledge of and experience with US laws, regulations, and industry guidance affecting the pharmaceutical, biotechnology, or lab industry.

Preferred Qualifications

• Familiarity or experience with FARs, DFARs, and other government contracting terms and rules.
• Demonstrated client service orientation, including eagerness to establish and own relationships with business owners and the ability to recognize and respond quickly and pragmatically to demanding clients.
• Sound business judgment and ability to navigate complex legal issues without losing sight of overall business goals.
• Strong verbal and written business communication skills, including the ability to synthesize and summarize complex and/or voluminous content into clear, concise, and actionable communications for non-attorneys.
• Ability to juggle multiple priorities, work under fast-paced conditions, make decisions comfortably, and demonstrate good judgment.
• Strong project management skills to prioritize tasks and goals to ensure timely, on-target, and within-budget outcomes.
• Initiative to solve problems and support process improvements and scalability within the Legal department.

Compensation & Benefits

• Salary Range: $172,000 - $258,000
• Other compensation elements include:
  • Equity grant
  • Bonus eligible

Location

This position may be remote and require occasional travel.

Work Authorization

The organization is not currently sponsoring candidates requiring work authorization support for this position.

Notes

• This employer provides equal employment opportunities and consideration without regard to protected characteristics, including race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and does not discriminate based on disability.
• Employment opportunities will not include requests for candidates to purchase anything out-of-pocket, including home office supplies and equipment.
• Malicious actors may pose as employees using fraudulent email aliases; legitimate employment opportunities are initiated through the organization’s careers process and extended after multiple interviews with verified employees.