Associate Director, Global R&D Compliance

Associate Director, Global R&D Compliance

Boston, MA | Life Sciences

Our client, a global pharmaceutical company, is seeking an attorney to join its Ethics & Compliance organization in a highly visible role supporting its global R&D and Medical Affairs functions.

This is an excellent opportunity for a life sciences attorney who wants to take on significant responsibility within a sophisticated global organization. The attorney will serve as a key compliance advisor to senior R&D and Medical Affairs leadership and will have broad exposure across the company’s global compliance program.

Responsibilities

• Serve as a primary compliance advisor to the company’s global R&D and Medical Affairs organizations
• Counsel on healthcare compliance matters involving HCPs, HCOs and Key Opinion Leaders
• Advise on fair market value (FMV), transparency reporting and HCP consulting arrangements
• Provide compliance guidance relating to clinical research, Investigator Initiated Studies, research funding and other R&D activities
• Advise on U.S. and international healthcare compliance requirements
• Support compliance risk assessments, monitoring and remediation initiatives
• Develop and deliver compliance training for R&D and Medical Affairs personnel
• Draft and implement compliance policies, procedures and related guidance
• Partner closely with senior business, legal and compliance leaders across a global organization

Qualifications

• JD and active bar membership strongly preferred
• Meaningful legal and compliance experience within the pharmaceutical or biotechnology industry
• Experience advising on healthcare compliance matters, including HCP interactions, transparency and FMV
• Experience supporting R&D and/or Medical Affairs strongly preferred
• Familiarity with applicable healthcare laws and regulations, including the Anti-Kickback Statute, False Claims Act, FDCA and relevant industry guidance
• In-house pharmaceutical or biotechnology experience preferred but not required
• Strong judgment, communication skills and ability to work effectively with senior business leaders
• Ability to operate independently in a fast-paced, global environment

Why This Opportunity

This is a particularly attractive opportunity for an attorney looking to step into a broader and more visible compliance role. The successful candidate will have significant exposure to senior leadership and the opportunity to become a key legal and compliance partner to a global R&D organization.