An Ethics Compliance Manager tracks employer compliance with ethical standards in addition to laws and regulations. Creates company policies, reviews departmental functions and protocol, follows developments in law and regulations affecting the industry and evolving ethical standards related to public regulations and industry practice.
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Description:
Position Overview:
The person in this role will provide day-to-day, tactical, practical, and risk-calibrated legal advice and counseling to the U.S. business on a broad array of strategic and operational matters within a highly regulated commercial biopharmaceutical environment. This position will report to the Senior Counsel and will work closely with other Legal and Compliance team members to support business partners across the organization, including marketing and market research, U.S. sales and sales training, patient advocacy and patient support/patient services, regulatory, compliance, and other cross-functional stakeholders. The ideal candidate will be able to effectively manage a high volume of operational legal matters and have prior experience counseling prescription drug or medical device companies on legal issues relating to advertising and promotion, scientific exchange, patient support programs, HCP and HCO interactions, field and customer engagement, and healthcare compliance. This is a hybrid position in our Burlington, Massachusetts office, with the potential for some travel.
Key Responsibilities:
Provide day-to-day, practical, and risk-calibrated legal advice to business partners on matters related to the operation and commercialization of a branded pharmaceutical business, including advertising and promotion, social media and digital engagement, scientific exchange, patient support programs, HCP and HCO interactions, field and customer engagement, healthcare fraud and abuse, product labeling, pharmacovigilance, product liability, and other matters relevant to the development, manufacture, and commercialization of prescription drugs Advise Commercial, Patient Support, Regulatory, Compliance, and other cross-functional teams on business initiatives in a manner that advances company strategy while identifying, assessing, and mitigating legal and compliance risks Provide legal support for HCP and HCO engagement workflows and related documentation, including speaker programs and consulting arrangements Draft, review, and negotiate commercial and healthcare-related agreements in collaboration with internal stakeholders Collaborate with Compliance and cross-functional stakeholders to support healthcare compliance programs addressing drug promotion, field and customer engagement, HCP and HCO interactions, financial arrangements with healthcare providers, transparency reporting, monitoring, training, and related documentation requirement Monitor legal and regulatory developments relevant to the U.S. business and provide practical guidance on emerging risks Develop and deliver legal training Contribute to Legal and Compliance Department projects, process improvements, and strategic initiatives, Work independently and collaboratively with U.S. and global legal, compliance, and cross-functional colleagues to manage high-volume legal, contract, and compliance workflows with sound judgment, business pragmatism, ownership, and attention to detail
Required Qualifications:
JD from an accredited law school and admission to practice in at least one U.S. jurisdiction; Massachusetts admission preferred or ability to obtain in-house counsel status 3+ years of legal experience advising life sciences companies, preferably including in-house experience with a prescription drug or medical device company Experience advising life science companies on issues, risks, contracts, or litigation related to the commercialization of branded pharmaceutical or medical device products Working knowledge of laws, regulations, and industry guidance applicable to pharmaceutical commercialization, including FDA advertising and promotion requirements, healthcare fraud and abuse laws, the Anti-Kickback Statute, the False Claims Act, OIG guidance, transparency requirements, and the PhRMA Code Ability to communicate clear, practical, and risk-calibrated legal advice to legal and non-legal stakeholders in a fast-paced business environment Strong analytical and organizational skills Sound business judgment, attention to detail, and ability to operate effectively in a lean, collaborative, and high-performing environment Fluency in
