Associate Director, Advertising and Promotional Compliance, US

Alexion • Boston, MA

5d • $150,000 - $225,000 • Hybrid

About The Position

Are you ready to shape how we communicate life-changing science to patients and healthcare professionals—safely, compliantly, and with impact? This role leads the US advertising and promotional compliance strategy for assigned products, ensuring our external communications are scientifically rigorous, fair-balanced, and fully aligned with FDA requirements. You will partner closely with cross-functional colleagues in medical, legal, regulatory, commercial, and regulatory operations to drive high-quality promotional and scientific materials from concept to submission. Can you anticipate regulatory risk and translate complex guidance into clear, actionable direction for teams? Your work will enable timely launches, confident market presence, and consistent, ethical engagement across a rapidly expanding portfolio serving people with significant unmet needs.

Requirements

• Bachelor’s Degree
• Minimum 5 years of relevant experience and/ or relevant PharmD post-doctoral Fellowship experience
• 5 years of U.S. advertising and promotional regulations
• Experience communicating and negotiating directly with OPDP and /or APLB
• Experience with global standards for advertising and promotion compliance
• Proven track record practicing sound judgment as it relates to risk assessment
• Knowledgeable on industry compliance requirements and non-compliance examples and trends
• Demonstrated ability to influence others and foster team collaboration
• Experience with launching new products and/or new indication
• Solid understanding of business goals and common marketing concepts/tools, including the internet and social media
• Proficiency using promotional review software, such as Veeva Promomats and Veeva Medcomms

Nice To Haves

• Advanced degree
• History having direct reports or mentoring junior team members

Responsibilities

• Reviewing US promotional and non-promotional/scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to global compliance standards and FDA regulations pertaining to prescription drug advertising, promotion, and communication as applicable
• Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and /or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253
• As needed, providing training support within Alexion on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
• In collaboration with their manager, providing advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products
• Ensuring stakeholder awareness of proposed and newly approved labeling changes
• Informing , reviewing and providing clear communication to all key stakeholders in both Promotional Review Committee (PRC) and Medical Review Committee (MRC) on planned label updates and how they may impact promotional and medical materials; provide key stakeholders with specific guidance on appropriate implementation of the label update, including ISI updates, for assigned therapeutic area in a timely manner
• In collaboration with their manager and the Medical Legal Regulatory (MLR) Coordinator, participating in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company products
• Maintaining regulatory expertise in product promotion compliance by keeping current with issued FDA enforcement actions and through attendance at relevant conferences and/or seminars . Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate
• Working with management and cross-functional partners to analyze changes to the regulatory landscape and determine any internal impact and communicate and provide guidance to all impacted key stakeholders
• Collaborate with ad/promo team and Reg Ops on creation and implementation of novel submission processes
• Participating /assisting in US labeling negotiations and FDA meetings as necessary

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level