Healthcare Compliance Officer, US Biomedicine *PC 1505

Your Role:

The Healthcare Compliance Officer will serve as the lead compliance authority for the US Biomedicine organization, overseeing the design, implementation, and execution of the company's corporate compliance and privacy programs, with a strong emphasis on promotional review, HCP/HCO interactions, and data governance. This individual will function as the legal and compliance representative on the Promotional Review Committee (PRC/MLR), support compliant commercialization of pharmaceutical products, and drive enterprise-wide compliance initiatives. Operating in a dynamic, small-team environment, the Healthcare Compliance Officer will also oversee internal investigations, support training and monitoring activities, and serve as a strategic advisor to business leaders, ensuring adherence to healthcare laws, regulations, and internal policies.

This position will report to the Chief Officer, North America Biomedicine.

Essential Duties and Responsibilities:

Corporate Compliance Strategy and Governance

• Serve as an independent advisor to senior leadership on compliance risks and obligations.
• Establish and maintain a compliance hotline and related communication programs to foster a culture of accountability and integrity.
• Provide compliance reporting and program updates to executive leadership and to the global Executive Committee, where appropriate.

Promotional Review and Commercial Compliance

• Serve as the compliance and legal lead on the PRC/MLR team, reviewing promotional and medical communications to ensure compliance with FDA, FTC, OIG, and PhRMA Code requirements.
• Advise Commercial, Medical Affairs, and Regulatory teams on labeling, disease awareness, advertising claims, and fair balance.
• Provide real-time legal and compliance guidance on marketing tactics, speaker programs, social media, and digital campaigns.
• Support the development of compliant launch strategies and commercial plans across therapeutic areas.

Policy Development and Compliance Operations

• Develop, implement, and update compliance policies, SOPs, and controls covering promotional practices, field activities, speaker programs, transparency, and medical engagements.
• Conduct training programs across Commercial, Medical, and corporate functions to promote awareness of compliance standards and ethical conduct.
• Monitor industry trends, enforcement actions, and evolving laws to maintain a proactive, risk-based compliance framework.

Privacy, Data Governance, and Cybersecurity Compliance

• Lead the privacy compliance program, ensuring adherence to HIPAA, GDPR, CPRA/CCPA, and other applicable data protection laws.
• Collaborate with Product, IT, and Commercial teams to integrate privacy by design, de-identification standards, and real-world data strategies into business processes.
• Partner with Information Security on vendor assessments, breach simulations, and cybersecurity preparedness.
• Guide business teams on permissible data use, third-party data sharing, and privacy terms in commercial or clinical agreements.

HCP/HCO Engagement and Transparency

• Provide legal and compliance oversight for interactions with healthcare professionals and organizations (HCPs/HCOs), including speaker programs, consulting agreements, educational grants, and charitable contributions.
• Ensure compliance with the Anti-Kickback Statute, Sunshine Act (Open Payments), and FMV guidelines.
• Support transparency reporting processes and compliance with applicable state and federal reporting obligations.

Internal Investigations, Auditing, and Risk Management

• Lead or support internal investigations related to code of conduct or compliance policy violations; oversee appropriate remediation and documentation.
• Partner with internal audit and finance teams to monitor compliance with financial controls, SOX requirements, and commercial activity oversight.
• Identify areas of risk and develop corrective action plans, track and report key compliance metrics to senior leadership.

Requirements:

• Juris Doctor (JD) degree from an accredited U.S. law school required; Active license to practice law in at least one U.S. jurisdiction required; Minimum of ten (10) years of legal, compliance, or regulatory experience within the pharmaceutical, biotech, life sciences, or healthcare industry.
• At least five (5) years in a compliance, legal, or regulatory affairs role with direct involvement in promotional review and commercial compliance.
• Experience with U.S. healthcare laws including FDA promotional regulations, Anti-Kickback Statute, False Claims Act, Sunshine Act, and OIG Compliance Guidance.
• Familiarity with global and U.S. data privacy laws (HIPAA, GDPR, CCPA/CPRA), cybersecurity law, and incident response procedures.
• Demonstrated success conducting internal investigations, leading training programs, and advising on complex regulatory matters.
• Experience working in a small, fast-paced, or pre-commercial biopharma organization preferred.

Knowledge, Skills & Abilities:

• Deep expertise in promotional compliance and legal risk associated with pharmaceutical marketing and communications.
• Strong knowledge of privacy, transparency, and HCP/HCO engagement regulations.
• Excellent analytical, interpersonal, and communication skills, with ability to influence at all levels of the organization.
• Ability to translate complex legal concepts into clear, actionable business guidance.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs and PPE must be worn.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity