Senior Manager – Commercial and Healthcare Compliance

Role Overview

• Promote a culture of ethics & integrity across all business functions in the US.
• Providing risk-based, solutions-oriented and pragmatic compliance guidance based upon internal requirements and/or external US laws, regulations, industry codes, and accepted guidance from authoritative US agencies (i.e., Office of Inspector General of the US Department of Health and Human Services).
• Development and implementation of US guidance (e.g., policies, guidelines, manuals, etc.) in support of the US Commercial business.
• Development and execution of training in support of the US Commercial business.
• Establish and maintain strong cross-functional business partnerships with the US Commercial business and supporting functions (e.g., Legal, Finance, IT, HR, etc.) through the provision of impactful and informative compliance guidance.
• Execution of monitoring activities of US field teams (e.g., US MSLs, US Account Managers, US Field Sales), communication of results, development and execution of remediation plans, when necessary, and creation and maintenance of documentation.
• Lead the alignment of US monitoring efforts with the global monitoring efforts to ensure the avoidance of duplication.
• Participation and administration in key US committees chaired by the US Commercial Compliance Lead to take notes, capturing action plans for follow-up, calendar maintenance and meeting scheduling (e.g., US Compliance Committee and US Policy Governance Committee).
• Participation on the Global Ethics & Compliance Team initiatives, as may be requested from time to time.

Requirements

• 5+ years of legal, compliance, audit, or commercial roles, of which at least 3 years specifically in the commercial biotech/pharmaceutical compliance role.
• Bachelor’s degree required.
• Experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, False Claims Act, Anti-Kickback Statute, the US Food, Drug, & Cosmetic Act, the Stark Law, and the US Federal Sentencing Guidelines.
• Experience executing compliance monitoring in the biotech or pharmaceutical industries.
• Solid understanding of compliance risks in the context of products governed by the US Food, Drug & Cosmetic Act.
• Experience interacting and collaborating with global colleagues.
• Ability to lead and facilitate discussions with senior leaders at the country and global levels.
• Ability to work independently and deliver on deadlines while managing multiple projects and priorities.
• Ability to work with multiple systems, analytical tools, databases, and reporting platforms.
• Understanding how to translate data into compliance insights that are actionable from a process improvement perspective.
• Proven ability to successfully collaborate with cross-functional teams to identify needs, provide sound and accurate compliance guidance and communicate solutions.
• Proficient in Microsoft Office applications, Sharepoint, LMS, Concur, and other CRM systems used in the pharmaceutical sales environment.

Benefits

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance
• …and more! More details to be shared.