Manager, Healthcare Compliance

Manager, Healthcare Compliance

About the Role

A biotechnology organization focused on advancing novel therapies for rare autoimmune conditions associated with significant patient burden is expanding its legal function. This position sits within the legal team and reports directly to the General Counsel. The individual in this role will provide day-to-day healthcare compliance support across the organization, helping to ensure that business activities remain aligned with applicable laws, regulations, and internal policies as the organization continues to grow.

Responsibilities

• Build out yearly monitoring and auditing plans that evaluate adherence to internal healthcare compliance policies and standard operating procedures, with coverage spanning speaker programs, advisory boards, consulting engagements, grants, medical education funding, and promotional activities
• Execute internal monitoring and audit activities, draft reports summarizing findings, and recommend corrective action plans
• Maintain ongoing oversight of corrective action plan progress
• Provide project management support to compliance governance bodies, such as the grant review committee, promotional materials review committee, and medical/regulatory/legal review committee
• Promote awareness across the workforce of internal approval pathways and reinforce adherence to those processes for relevant activities
• Monitor completion of mandatory compliance training and drive toward full participation across staff
• Act as a go-to compliance resource for colleagues within the legal function
• Partner cross-functionally with finance, regulatory affairs, and quality assurance on compliance-related initiatives

Qualifications

• Bachelor's degree in a life sciences field, business, or a comparable discipline
• A minimum of 5 years of compliance experience within the pharmaceutical or biotechnology sector
• Demonstrated experience supporting field-based teams, including monitoring and auditing activities
• Functional understanding of healthcare compliance laws and regulations, OIG guidance, and the PhRMA Code
• Strong written and verbal communication, interpersonal, and organizational skills, with an ability to engage effectively across all levels of the organization while preserving the independence required of a compliance function
• Demonstrated success operating in fast-moving, innovative settings and handling multiple concurrent workstreams
• Strong attention to detail, sound judgment, and a high standard of personal ethics

Preferred Qualifications

• Certified in Healthcare Compliance (CHC) designation

Core Competencies

• Business Partnership — establishes credibility and trust with commercial colleagues while preserving the independence required of the compliance role
• Communication & Influence — articulates compliance expectations in a constructive manner
• Accountability — owns deliverables end-to-end and executes with discipline
• Integrity — operates with consistently high ethical standards