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Job description
Responsibilities
Define and lead the Compliance & Ethics strategy for Commercial and other key business areas, aligning priorities with growth, product lifecycle, and market expansion.
Serve as the accountable Compliance & Ethics business partner for Commercial, Medical Affairs, Patient Services, and Patient Advocacy.
Represent Compliance in cross-functional leadership discussions and embed compliance into business planning.
Design and build scalable compliance processes to support product launches and geographic expansion.
Identify, assess, and advise on mitigation of compliance risks across external-facing activities.
Provide actionable guidance on HCP engagements, sponsorships, grants/charitable contributions, patient support programs, patient advocacy group interactions, market access, and emerging commercialization models.
Partner with Commercial leadership to enable compliance through processes and procedures.
Oversee development, implementation, and effectiveness of Compliance & Ethics policies, standards, and governance.
Provide input into risk-based monitoring and auditing using data/analytics.
Ensure compliance requirements are addressed across program activities (risk assessments, third-party due diligence, fair market value, HCP tiering, needs assessments).
Foster a “speak‑up” culture.
Provide guidance on key regulations/standards and industry codes (Anti‑kickback laws, False Claims Act, Fraud/abuse laws, DOJ/OIG guidance, PhRMA Code).
Qualifications & Experience
10+ years in pharmaceutical/biotech compliance.
Experience as a compliance business partner to Commercial (e.g., Sales/Marketing/Thought Leader Liaisons).
Strong knowledge of U.S. Anti‑Kickback Statute, U.S. False Claims Act, PhRMA Code, OIG guidance, and applicable state regulations.
Experience advising on HCP engagements, grants, sponsorships, and patient support programs.
Track record building/scaling compliance and ethics programs.
Excellent communication and prioritization; collaborative, cross‑functional.
B.A./B.S. degree required.
Travel up to 25%.
Skills
Maintain deep expertise in applicable laws and monitor industry compliance developments.
Drive compliance operations innovation via technology, automation, and process improvement.
Champion transparency, ethical decision‑making, and accountability.
Lead role‑specific, risk‑based training and awareness programs.
Pay Range: $250,000 – $280,000 USD
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Worksite address
lexington, MA, 02173, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.